Simpóni

Italy
Brand name Simpóni
Form solution for injection, in pre-filled pen
Active substance / Dosage
GOLIMUMAB
Prescription type Restricted prescription – dispensable on hospital or specialist prescription
ATC code
L04AB06
Registration number 039541
Manufacturer JANSSEN-CILAG INTERNATIONAL N.V.
Simpóni solution for injection, in pre-filled pen

Table of Contents

Package leaflet: Information for the user

Simponi 45 mg/0.45 mL solution for injection in pre-filled pen

For paediatric patients weighing less than 40 kg
golimumab
Please read all of this leaflet carefully before you start using this medicine because it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Your doctor will provide you with a Patient Alert Card containing important safety information
that you should be aware of before and during treatment with Simponi.
Contents of this leaflet

  1. What Simponi is and what it is used for
  2. What you need to know before using Simponi
  3. How to use Simponi
  4. Possible side effects
  5. How to store Simponi
  6. Contents of the pack and other information

1. What Simponi is and what it is used for

Simponi contains an active substance called golimumab.
Simponi belongs to a group of medicines known as "TNF blockers". It is used in children
aged 2 years and older for the treatment of polyarticular juvenile idiopathic arthritis and in
children aged 2 years and older and weighing more than 15 kg for the treatment
of pediatric ulcerative colitis.
Simponi works by blocking the action of a protein called "tumour necrosis factor alpha" (TNF-
α). This protein is involved in inflammatory processes in the body, and by blocking it, inflammation in the body can be reduced.
Polyarticular juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis is an inflammatory disease that causes pain and swelling
in the joints of children. If you have polyarticular juvenile idiopathic arthritis, other medicines will be tried first. If you do not respond adequately to these medicines, Simponi will be given to you in combination with methotrexate to treat the disease.
Pediatric ulcerative colitis
Ulcerative colitis is an inflammatory disease of the intestine. If you have ulcerative colitis, other medicines will be administered first. If you do not respond adequately to these medicines, Simponi will be administered to treat your disease.

2. What you need to know before using Simponi

Do not use Simponi

  • If you are allergic (hypersensitive) to golimumab or to any of the other ingredients of this medicine (listed in section 6).
  • If you have tuberculosis (TB) or any other serious infection.
  • If you have moderate or severe heart failure.

If you are unsure whether any of the above conditions apply to you, speak with your doctor, pharmacist, or nurse before using Simponi.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Simponi.
Infections
Inform your doctor immediately if you have had or develop symptoms of infection during or after treatment with Simponi. Symptoms of infection include fever, cough, shortness of breath, flu-like symptoms, diarrhoea, wounds, dental problems, or a burning sensation when urinating.

  • You may be more likely to get infections while using Simponi.
  • Infections may progress more quickly and be more severe. In addition, past infections may recur.

Tuberculosis (TB)
Inform your doctor immediately if you notice symptoms of TB during treatment. Symptoms of TB include persistent cough, weight loss, feeling tired, fever, or night sweats.

  • Cases of TB have been reported in patients treated with Simponi, rarely even in patients who have been treated with medicines for TB. Your doctor will perform tests to assess whether you have TB. These tests will be recorded on your Patient Card.
  • It is very important that you inform your doctor if you have previously had TB or if you have been in close contact with someone who has or has had TB.
  • If your doctor believes you are at risk of TB, you may be treated with TB medicines before starting Simponi.

Hepatitis B virus (HBV)

  • Inform your doctor if you are a carrier of, or have or have had hepatitis B, before being given Simponi.
  • Inform your doctor if you think you may be at risk of contracting hepatitis B.
  • Your doctor must perform tests to assess whether you have hepatitis B.
  • Treatment with TNF blockers such as Simponi can cause reactivation of the hepatitis B virus in patients who are carriers of this virus, which in some cases may lead to death.

Invasive fungal infections
Inform your doctor immediately if you have lived in or travelled to an area where infections caused by specific types of fungi that can affect the lungs or other parts of the body are common (called histoplasmosis, coccidioidomycosis, or blastomycosis). Ask your doctor if you are unsure whether these fungal infections are common in the area where you have lived or travelled.
Tumours and lymphoma
Inform your doctor if you have or have ever had lymphoma (a type of blood cancer) or other types of cancer before being given Simponi.

  • Your risk of developing lymphoma or another type of cancer may be increased if you use Simponi or other TNF blockers.
  • Patients with severe rheumatoid arthritis or other inflammatory diseases, especially those who have had the disease for a long time, may have a higher than average risk of developing lymphoma.
  • Cases of tumours, including unusual types, sometimes fatal, have been reported in children and adolescents treated with TNF blocker medicines.
  • In rare cases, a specific and serious type of lymphoma called hepatosplenic T-cell lymphoma has been observed in patients taking other TNF blockers. Most of these patients were adolescent or young adult males. This type of cancer has usually been fatal. Almost all of these patients had also received medications known as azathioprine or 6-mercaptopurine. Inform your doctor if you are taking azathioprine or 6-mercaptopurine with Simponi.
  • Patients with severe persistent asthma, chronic obstructive pulmonary disease (COPD), or regular smokers may have an increased risk of cancer with treatment with Simponi. If you have severe persistent asthma, COPD, or are a regular smoker, discuss with your doctor whether treatment with a TNF blocker is appropriate.
  • Some patients treated with golimumab have developed certain types of skin cancer. If any changes in the appearance of your skin or skin growths appear during or after therapy, inform your doctor.

Heart failure
Inform your doctor immediately if you notice new symptoms of heart failure or worsening of existing symptoms. Symptoms of heart failure include shortness of breath or swelling of the feet.

  • Cases of new-onset congestive heart failure or worsening of pre-existing heart failure have been reported with TNF blockers, including Simponi. Some of these patients died.
  • If you have mild heart failure and are treated with Simponi, your doctor will monitor you closely.

Nervous system disorders
Inform your doctor immediately if you have ever been diagnosed with or develop symptoms of a demyelinating disease, such as multiple sclerosis. Symptoms may include changes in vision, weakness in arms and legs, numbness, or tingling anywhere in the body. Your doctor will decide whether Simponi should be administered.

Surgery or dental procedures

  • Inform your doctor if you are scheduled for any surgery or dental procedures.
  • Inform the surgeon or dentist performing the procedure that you are being treated with Simponi, and show them your Patient Card.

Autoimmune diseases
Inform your doctor if you develop symptoms of a disease called lupus. Symptoms include persistent skin rash, fever, joint pain, and fatigue.

  • In rare cases, people treated with TNF blockers have developed lupus.

Blood disorders
In some patients, the body may not produce enough blood cells that help the body fight infections or help stop bleeding. If you develop persistent fever of unknown origin, bruise easily, bleed easily, or appear very pale, contact your doctor immediately. Your doctor may decide to stop treatment.
If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before using Simponi.
Vaccinations
Inform your doctor if you have recently been vaccinated or if you plan to be vaccinated.

  • You must not receive certain vaccines (live vaccines) while being treated with Simponi.
  • Some vaccinations may cause infections. If you received Simponi while pregnant, your baby may have an increased risk of contracting such an infection for approximately six months after the last dose received during pregnancy. It is important to inform the paediatrician and other healthcare providers about the use of Simponi so they can decide when your baby should receive any vaccine.

Talk to your child’s doctor about vaccinations for your child. If possible, your child should be up to date with all vaccinations before using Simponi.
Therapeutic infectious agents
Talk to your doctor if you have recently taken or plan to take treatment with a therapeutic infectious agent (such as BCG instillation used for cancer treatment).
Allergic reactions
Inform your doctor immediately if you develop symptoms of an allergic reaction after treatment with Simponi. Symptoms of an allergic reaction may include swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing, skin rash, hives, or swelling of hands, feet, and ankles.

  • Some of these reactions may be serious or, rarely, life-threatening.
  • Some of these reactions have occurred after the first dose of Simponi.

Children
Simponi is not recommended for children under 2 years of age with polyarticular juvenile idiopathic arthritis or paediatric ulcerative colitis, as it has not been studied in these populations.
Other medicines and Simponi

  • Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including any other medicines used to treat polyarticular juvenile idiopathic arthritis.
  • You must not take Simponi with medicines containing the active substance anakinra or abatacept. These medicines are used to treat rheumatic diseases.
  • Inform your doctor or pharmacist if you are taking any other medicine that affects the immune system.
  • You must not receive certain vaccines (live vaccines) while being treated with Simponi.

If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before using Simponi.
Pregnancy and breastfeeding
Talk to your doctor before using Simponi if:

  • You are pregnant, planning to become pregnant, or become pregnant while using Simponi. Information on the effects of this medicine in pregnant women is limited. If you need to be treated with Simponi, you must avoid pregnancy by using an effective method of contraception during treatment and for at least 6 months after the last injection of Simponi. Simponi should be used during pregnancy only if strictly necessary.
  • You must wait at least 6 months after your last Simponi treatment before breastfeeding. You must stop breastfeeding if you need to be given Simponi.
  • If you received Simponi during pregnancy, your baby may have an increased risk of contracting an infection. It is important to inform the paediatrician and other healthcare providers about the use of Simponi before your baby receives any vaccine (for more information, see the section on vaccinations). If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Simponi has a minor influence on the ability to drive and use machines. After using Simponi, dizziness may occur. In this case, do not ride a bicycle, drive, or operate tools or machinery.
Simponi contains latex, sorbitol, and polysorbate
Latex sensitivity
A part of the pre-filled pen, the cap covering the needle, contains latex. Since latex can cause severe allergic reactions, inform your doctor before using Simponi if you or the person assisting you is allergic to latex.
Sorbitol intolerance
This medicine contains 18.5 mg of sorbitol (E420) in each pre-filled pen. Each 0.05 mL of medicine contains 2.05 mg of sorbitol (E420).
Polysorbate 80
This medicine contains 0.068 mg of polysorbate 80 (E433) per pre-filled pen. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Simponi

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

How much Simponi is administered

Polyarticular juvenile idiopathic arthritis in children aged 2 years and older:

  • Children weighing less than 40 kg: The recommended dose of Simponi in children weighing less than 40 kg depends on weight and height. Your doctor will tell you the correct dose to use. The dose should be administered once a month, on the same day each month.
  • Children weighing at least 40 kg: For children with a body weight of at least 40 kg, a fixed-dose pre-filled pen or pre-filled syringe containing 50 mg is available. For the 50 mg dose, see section 3 “How to use Simponi” in the package leaflet for Simponi 50 mg pre-filled pen or pre-filled syringe.
  • Please consult your doctor before taking the fourth dose. Your doctor will decide whether you should continue treatment with Simponi.

Paediatric ulcerative colitis in children aged 2 years and older with body weight of at least 15 kg:

  • Children weighing at least 15 kg:
  • The recommended dose of Simponi for children aged 2 years and older with body weight of at least 15 kg depends on weight. Your doctor will tell you the correct dose to use.
  • For children with a body weight of at least 15 kg with ulcerative colitis, a 50 mg pre-filled syringe or a 100 mg pre-filled syringe is available. For the 50 mg dose, see section 3 “How to use Simponi” in the package leaflet for Simponi 50 mg pre-filled syringe. For the 100 mg dose, see section 3 “How to use Simponi” in the package leaflet for Simponi 100 mg pre-filled syringe.

How Simponi is administered

  • Simponi is administered by injection under the skin (subcutaneously).
  • Initially, your doctor or nurse will administer Simponi to you. However, you and your doctor may decide that you can self-inject Simponi or that you can inject it for the child. In this case, you will be instructed on how to inject Simponi. Speak with your doctor if you have any questions about self-administration of the injection. Detailed “Instructions for use” are provided at the end of this leaflet.

If you use more Simponi than you should

If you have used or been administered too much Simponi (by injecting too much in a single administration or using it too frequently), inform your doctor or pharmacist immediately. Always carry this leaflet and the outer packaging with you, even if empty.

If you forget to use Simponi

If you forget to use Simponi on the scheduled day, inject the missed dose as soon as you remember.

Do not use a double dose to make up for a forgotten dose.

When to inject the next dose:

  • If the delay is less than 2 weeks, inject the missed dose as soon as you remember and continue following the original schedule.
  • If the delay is more than 2 weeks, inject the missed dose as soon as you remember, then inform your doctor or pharmacist and ask when you should take the next dose.

If you have any doubts about what to do, consult your doctor or pharmacist.

If you stop using Simponi

If you are considering stopping treatment with Simponi, consult your doctor or pharmacist first.

If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some patients may experience serious side effects that may require medical treatment. Side effects may also occur several months after the last injection.

Inform your doctor immediately if you notice any of the following serious side effects of Simponi, including:

  • Allergic reactions, which can be severe, or rarely, potentially life-threatening (rare). Symptoms of an allergic reaction may include swelling of the face, lips, mouth or throat, which may cause difficulty swallowing or breathing, rash, hives, swelling of the hands, feet and ankles. Some of these reactions have occurred after the first dose of Simponi.
  • Serious infections (including TB, bacterial infections including severe blood infections and pneumonia, serious fungal infections and other opportunistic infections) (common). Symptoms of infection may include fever, tiredness, persistent cough, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, dental problems and a burning sensation when urinating.
  • Reactivation of hepatitis B virus if you are a carrier or have previously had hepatitis B (rare). Symptoms may include yellowing of the skin and eyes, dark brown urine, pain in the right side of the abdomen, fever, feeling unwell, malaise and extreme tiredness.
  • Nervous system disorders such as multiple sclerosis (rare). Symptoms of nervous system disorders may include changes in vision, weakness in arms or legs, numbness or tingling in any part of the body.
  • Lymph node cancer (lymphoma) (rare). Symptoms of lymphoma may include swollen lymph nodes, weight loss or fever.
  • Heart failure (rare). Symptoms of heart failure may include shortness of breath or swelling of the feet.
  • Signs of immune system disorders known as:
  • Lupus (rare). Symptoms may include joint pain or a rash on the cheeks or arms that is sensitive to sunlight.
  • Sarcoidosis (rare). Symptoms may include a persistent cough, shortness of breath, chest pain, fever, swollen lymph nodes, weight loss, skin rashes and blurred vision.
  • Swelling of small blood vessels (vasculitis) (rare). Symptoms may include fever, headache, weight loss, night sweats, rash and nerve problems such as numbness and tingling.
  • Skin cancer (uncommon). Symptoms of skin cancer may include changes in the appearance of the skin or skin growths.
  • Blood disorders (common). Symptoms of blood disorders may include a fever that does not go away, a tendency to bruise or bleed easily, or looking very pale.
  • Blood cancer (leukaemia) (rare). Symptoms of leukaemia may include fever, feeling tired, frequent infections, bruising and night sweats.

Inform your doctor immediately if you notice any of the symptoms listed above.

The following additional side effects have been observed with Simponi:

Very common side effects (may affect more than 1 in 10 people):

  • Upper respiratory tract infections, sore throat or hoarseness, cold

Common side effects (may affect up to 1 in 10 people):

  • Abnormal liver function tests (increased liver enzymes), detected during blood tests performed by your doctor
  • Dizziness
  • Headache
  • Numbness or tingling sensation
  • Superficial fungal infections
  • Abscess
  • Bacterial infections (such as cellulitis)
  • Reduction in red blood cells
  • Reduction in white blood cells
  • Positive blood test for lupus
  • Allergic reactions
  • Indigestion
  • Stomach pain
  • Feeling unwell (nausea)
  • Influenza
  • Bronchitis
  • Sinus infection
  • Facial herpes
  • High blood pressure
  • Fever
  • Asthma, shortness of breath, wheezing
  • Stomach and intestinal disorders including inflammation of the lining of the stomach and colon, which may cause fever
  • Mouth pain and ulcers
  • Injection site reactions (including redness, hardening, pain, bruising, itching, tingling and irritation)
  • Hair loss
  • Skin rash and itching
  • Difficulty sleeping
  • Depression
  • Feeling weak
  • Bone fractures
  • Chest pain

Uncommon side effects (may affect up to 1 in 100 people):

  • Kidney infection
  • Cancer, including skin cancer and non-cancerous swellings or small masses, including moles
  • Skin blisters
  • Severe infection throughout the body (sepsis), sometimes including low blood pressure (septic shock)
  • Psoriasis (including on palms of hands and/or soles of feet and/or in the form of skin blisters)
  • Reduction in platelets
  • Combined reduction in platelets, red blood cells and white blood cells
  • Thyroid disorders
  • Increased blood sugar levels
  • Increased cholesterol levels in the blood
  • Balance disorders
  • Vision disorders
  • Inflamed eye (conjunctivitis)
  • Eye allergy
  • Sensation of irregular heartbeat
  • Constriction of blood vessels in the heart
  • Blood clots
  • Flushing
  • Constipation
  • Chronic lung inflammation
  • Acid reflux
  • Gallstones
  • Liver disorders
  • Breast disorders
  • Menstrual disorders

Rare side effects (may affect up to 1 in 1,000 people):

  • Inability of the bone marrow to produce blood cells
  • Severe reduction in the number of white blood cells
  • Infection of joints or surrounding tissues
  • Poor wound healing
  • Inflammation of blood vessels in internal organs
  • Leukaemia
  • Melanoma (a type of skin tumour)
  • Merkel cell carcinoma (a type of skin tumour)
  • Lichenoid reactions (itchy purple-red rash and/or white-grey thread-like lines on mucous membranes)
  • Skin peeling
  • Immunological disorders that may affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
  • Pain and discoloration in fingers of the hands or feet
  • Taste disorders
  • Bladder disorders
  • Kidney disorders
  • Inflammation of blood vessels in the skin causing a rash

Side effects with unknown frequency:

  • A rare blood tumour affecting mainly young people (hepatosplenic T-cell lymphoma)
  • Kaposi's sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma most commonly presents with purple lesions on the skin
  • Worsening of a condition called dermatomyositis (which presents as a rash associated with muscle weakness)

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Simponi

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date stated on the label and carton following "Exp". The expiry date refers to the last day of that month.
  • Store in a refrigerator (2 °C–8 °C). Do not freeze.
  • Keep the pre-filled pen in the outer packaging to protect the medicine from light.
  • This medicine may also be stored outside the refrigerator at temperatures up to a maximum of 25 °C for a single period of up to 30 days, but not beyond the original expiry date printed on the carton. Write the new expiry date on the carton indicating day/month/year (no more than 30 days after the medicine has been removed from the refrigerator). Do not re-refrigerate this medicine once it has reached room temperature. Dispose of this medicine if not used within the new expiry date or within the printed expiry date on the carton, whichever comes first.
  • Do not use this medicine if you notice that the liquid is not clear to pale yellow, if it is cloudy, or if it contains foreign particles.
  • Do not dispose of any medicine via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Simponi Contains
The active substance is golimumab. A single-use pre-filled pen contains 0.45 mL of solution with 45 mg of golimumab.
1 mL contains 100 mg of golimumab.
The other ingredients are sorbitol (E420), histidine, monohydrochloride monohydrate of histidine, polysorbate 80 (E433), and water for injections. For more information on sorbitol (E420) and polysorbate 80 (E433), see section 2.

Description of the Appearance of Simponi and Contents of the Pack
Simponi is supplied as an injectable solution in a single-use pre-filled pen, VarioJect.
Simponi is available in packs containing 1 pre-filled pen.
The solution is from clear to slightly opalescent (pearl-like sheen), from colourless to pale yellow, and may contain a few small translucent or white protein particles. Do not use Simponi if the solution has changed colour, is cloudy, or contains visible foreign particles.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB "JOHNSON & JOHNSON"
Tel/Tél: 0800 93 377 Tel: +370 5 278 68 88
[email protected] [email protected]

България Luxembourg/Luxemburg
„Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Тел.: +359 2 489 94 00 Tél/Tel: 800 29 504
[email protected] [email protected]

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD
Tlf.: +45 4594 8282 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: 0800 242 42 42
[email protected] [email protected]

Eesti Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]

Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε. Tel: +43 1 610 300
Tηλ: +30 210 80 90 000

España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.: +48 22 237 60 00
[email protected]

France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected] [email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor ehf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]

Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Τηλ: +357 22 207 700 Tfn: +46 8 626 50 00
[email protected]

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561
[email protected]

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

Instructions for use

Simponi 45 mg/0.45 mL

prefilled pen injection solution, VarioJect
For pediatric use
SINGLE USE

White and blue medical autoinjector with central transparent window and lateral graduated scale showing 0.45 and 0.1 ml markings, and an orange arrow Stylized logo composed of an upper light blue shape resembling a leaf or petal above a dark blue and light blue geometric figure

Know your dose
Record the prescribed dose in the space above.
If you are unsure of your dose, confirm it with your doctor.
Important
If your doctor determines that Simponi injections may be administered at home by you or by someone assisting you, you must be trained on how to correctly prepare and inject Simponi.
Read these instructions for use before using the Simponi prefilled pen and each time you receive a new prefilled pen, as there may be new information.
Before starting the injection, also read carefully the "Package leaflet: information for the user". These instructions do not replace discussions with your doctor about your condition or treatment.
If you have not been trained or if you have any questions, consult your doctor, nurse, or pharmacist.

White stylized thermometer icon with graduated scale on a square blue background with rounded corners

Storage information
Store in the refrigerator at 2°C – 8°C.
May be stored at room temperature (up to 25°C) for a single period of up to 30 days, but not beyond the original expiry date. Write the new expiry date on the back of the box indicating day/month/year (no more than 30 days after the medicine has been removed from the refrigerator). Do not return this medicine to the refrigerator once it has reached room temperature.
Keep the Simponi prefilled pen and all medicines out of sight and reach of children.
General information
The prefilled pen is a manual injection pen that allows you to set a specific prescribed dose. Each prefilled pen can deliver from 0.1 mL to 0.45 mL (corresponding to 10 mg – 45 mg of golimumab) in 0.05 mL increments.
Before starting to use this prefilled pen, you must have learned how to:

  • Remove air bubbles
  • Set the prescribed dose
  • Manually press the plunger to inject the contents, as with a syringe

The prefilled pen must be used only once. Dispose of the prefilled pen after use.
Do not attempt to use any medicine remaining in the prefilled pen.
Do not share the prefilled pen with others.
Do not shake it.

White stylized telephone handset icon on a bright blue square background

Need help?
If you have questions, consult your doctor, nurse, or pharmacist. For further assistance, refer to the Package leaflet to find information about the local representative.
Preparation steps

Schematic drawing in perspective of a white three-dimensional rectangle with blue borders and light blue gradient sides on a gray background

Inspect the box
Check the expiry date ("Exp.") printed or written on the back of the box.
Do not use the medicine if the expiry date has passed.
Do not administer the injection if the seals on the box are broken. Contact your doctor or pharmacist to obtain a new prefilled pen.

Blue circular icon with black hands indicating a time interval highlighted by a light blue section on the right side of the dial

Remove the prefilled pen from the box
Leave the prefilled pen at room temperature for at least 30 minutes, and keep it out of reach of children.
Do not heat it in any other way.
You will need:

  • 1 alcohol swab
  • 1 cotton ball or gauze pad
  • 1 adhesive bandage
  • 1 sharps disposal container (see step 3)

Overview of the prefilled pen

Diagram of a syringe with labels: tip, hidden needle, viewing window, orange band, dose mark, dose lines, and plunger

Overview of the prefilled pen
Orange
Dose
Thin Viewing Loading
Needle lines
Tip window band
Hidden
Cap*
Orange Dose
Needle Plunger
Protection Selection
Do not remove until
Notch
instructions indicate.
IMPORTANT:
Do not press on the orange needle protection before injection, otherwise it will lock and the dose will not be administered.
Do not lift the prefilled pen from the skin during injection, otherwise the orange needle protection will lock and the full dose will not be administered.
*CHOKING HAZARD! Keep out of reach of children.

1. Prepare the injection

Stylized diagram of a human torso with blue areas indicating application sites on arm, abdomen, and thighs

Choose an injection site
Select one of the following areas for the injection:

  • Front of the thighs (recommended)
  • Lower abdomen Do not use the area within 5 centimeters around the navel.
  • Outer area of the upper arm (if the injection is administered by someone assisting you)
    For each injection, choose a different site within the selected area. Do not administer the injection in areas where the skin is tender, bruised, red, scaly, hard, or has scars.
Stylized drawing showing two hands washing with foam and one hand applying a bandage to a skin surface with a black line

Clean the injection site
Wash your hands thoroughly with soap and warm water.
Wipe the injection site with an alcohol swab and let it dry.
Do not touch, fan, or blow on the injection site after cleaning.

Detail of a white medical device with an oval transparent window showing the liquid inside

Inspect the liquid
Remove the pre-filled pen from its packaging.
Check the liquid in the viewing window. It should appear from clear to slightly
opalescent (pearly-looking) and from colorless to pale yellow, and may contain a few small
particles of translucent or white protein. One or more air bubbles may also be present. This is
normal.
Do not administer the injection if the liquid is discolored, cloudy, or contains large
particles. If in doubt, contact your doctor or pharmacist to obtain a new pre-filled pen.

Illustration of a hand pressing the side button of a white medical injection pen with a dark blue cap

Tap to bring air bubbles to the surface
Hold the pre-filled pen upright with the blue cap facing upwards.
Gently tap the pre-filled pen near the viewing window with your finger. This will help air bubbles rise to the surface.

A hand holding a white and orange medical device while

Remove the cap
Keep holding the pre-filled pen in an upright position, then twist and remove the cap.
IMPORTANT: Do not press on the orange needle shield before injecting, otherwise it will lock and the dose will not be delivered.
Administer the injection within 5 minutes after removing the cap.
Do not reinsert the cap, as this may damage the needle inside the pre-filled pen.
Do not use the pre-filled pen if it has been dropped without the cap.
Contact your doctor or pharmacist to obtain a new pre-filled pen.

Illustration of a medical device held in hand with a blue arrow pointing toward

Remove air bubbles*
Continue holding the pre-filled pen in an upright position.
Gently press the plunger upward with your thumb until it stops. Some liquid will come out. This is
normal.
The orange loading band will disappear.
*Removing air bubbles ensures the correct dose is delivered.
After removing the air bubbles, you may see a line inside the viewing window. This is normal.

2. Injecting Simponi using the pre-filled pen

Illustration of a hand rotating downward the upper part of a white medical device with blue indicators showing X.XX L

Set the prescribed dose
Rotate the plunger until the line corresponding to the prescribed dose aligns with the dose indicator mark. The pre-filled pen is now ready for use.
Dose options:
0.1 mL
0.15 mL
0.2 mL
0.25 mL
0.3 mL
0.35 mL
0.4 mL
0.45 mL

A hand holds an injection pen ready to apply it to the skin with a blue arrow pointing downward and an enlarged detail of the tip

Insert the needle and hold in place
IMPORTANT: Do not lift the pre-filled pen away from the skin during injection, otherwise the orange needle shield will lock and the full dose will not be delivered.
Do not press the plunger while inserting the needle.
Push and hold the tip of the pre-filled pen firmly against the skin so that the orange shield moves upward until it stops. A small amount of orange will become visible.

A hand holds a vertical white injection pen with a blue arrow pointing downward and an enlarged detail of the top part

Inject Simponi
Continue to hold the pre-filled pen against the skin.
Gently press the plunger until it stops.
If a low dose is set, the plunger will move only slightly.
You can verify the administered dose by checking the dose indicator mark.
Do not remove the pre-filled pen yet.

Illustration of a hand pressing a medical device onto the skin next to a timer indicating application time

Continue holding, then lift away
Keep holding the pre-filled pen against the skin for approximately 5 seconds.
It is normal for some medication to remain visible in the viewing window.
Lift the pre-filled pen away from the skin.
The orange needle shield will extend and lock automatically.

3. After the injection

A hand holds an injection pen ready to be placed into a biohazard waste container with biohazard symbol

Dispose of the prefilled pen
Place the used prefilled pen into a sharps container immediately after use. Make sure to dispose of the container according to the instructions provided by your doctor or nurse when the container is full.

A hand holds a white cotton pad and gently presses it onto a small wound or skin area with a light gray circle

Check the injection site
There may be a small amount of blood or liquid at the injection site.
Press a cotton ball or gauze pad against the skin until bleeding stops.
Do not rub the injection site.
If needed, you may cover the injection site with a plaster. The injection is complete!

Package leaflet: Information for the user

Simponi 50 mg solution for injection in pre-filled pen

golimumab
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Your doctor will provide you with a Patient Information Card containing important safety information that you should be aware of before and during treatment with Simponi.
Contents of this leaflet

  1. What Simponi is and what it is used for
  2. What you need to know before using Simponi
  3. How to use Simponi
  4. Possible side effects
  5. How to store Simponi
  6. Contents of the pack and other information

1. What Simponi is and what it is used for

Simponi contains an active substance called golimumab.
Simponi belongs to a group of medicines known as "TNF blockers". It is used in adults
for the treatment of the following inflammatory diseases:

  • Rheumatoid arthritis
  • Psoriatic arthritis
  • Axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis
  • Ulcerative colitis

In children aged 2 years and older, Simponi is used to treat polyarticular juvenile idiopathic arthritis.
Simponi works by blocking the action of a protein called "tumour necrosis factor alpha" (TNF-α). This protein is involved in inflammatory processes in the body, and by blocking it, inflammation in the body can be reduced.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints. If you have active rheumatoid arthritis, you will initially be treated with other medicines. If you do not respond adequately to these medicines, you will be treated with Simponi in combination with another medicine called methotrexate to:

  • Reduce the signs and symptoms of the disease.
  • Slow down damage to bones and joints.
  • Improve physical function.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory skin disease. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you will be treated with Simponi to:

  • Reduce the signs and symptoms of the disease.
  • Slow down damage to bones and joints.
  • Improve physical function.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis
Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory diseases of the spine. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you will be treated with Simponi to:

  • Reduce the signs and symptoms of the disease.
  • Improve physical function.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the intestine. If you have ulcerative colitis, you will first be given other medicines. If you do not respond adequately to these medicines, Simponi will be given to treat your disease.

Polyarticular juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis is an inflammatory disease that causes joint pain and swelling in children. If you have polyarticular juvenile idiopathic arthritis, you will first be given other medicines. If you do not respond adequately to these medicines, you will be given Simponi in combination with methotrexate to treat the disease.

2. What you need to know before using Simponi

Do not use Simponi

  • If you are allergic (hypersensitive) to golimumab or to any of the other ingredients of this medicine (listed in section 6).
  • If you have tuberculosis (TB) or any other serious infection.
  • If you have moderate or severe heart failure.

If you are unsure whether any of the conditions listed above may apply to you, speak with your doctor, pharmacist, or nurse before using Simponi.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Simponi.
Infections
Tell your doctor immediately if you have had or develop symptoms of infection during or after treatment with Simponi. Symptoms of infection include fever, cough, shortness of breath, flu-like symptoms, diarrhoea, wounds, dental problems, or a burning sensation when urinating.

  • You may be more likely to get infections while using Simponi.
  • Infections may progress more quickly and be more severe. In addition, past infections may recur.

Tuberculosis (TB)
Tell your doctor immediately if you notice symptoms of TB during treatment. Symptoms of TB include a persistent cough, weight loss, feeling tired, fever, or night sweats.

  • Cases of TB have been reported in patients treated with Simponi, occasionally even in patients who have been treated with medicines for TB. Your doctor will perform tests to assess whether you have TB. Your doctor will record these tests on the Patient Card.
  • It is very important that you inform your doctor if you have previously had TB or if you have been in close contact with someone who has or has had TB.
  • If your doctor considers you to be at risk of TB, you may be treated with TB medicines before Simponi is administered to you.

Hepatitis B virus (HBV)

  • Inform your doctor if you are a carrier of or have or have had hepatitis B before Simponi is administered to you.
  • Inform your doctor if you think you may be at risk of contracting hepatitis B.
  • Your doctor must perform tests to assess whether you have hepatitis B.
  • Treatment with TNF blockers such as Simponi can cause reactivation of the hepatitis B virus in patients who carry this virus, which in some cases may lead to death.

Invasive fungal infections
Inform your doctor immediately if you have lived in or travelled to an area where infections caused by specific types of fungi that can affect the lungs or other parts of the body (called histoplasmosis, coccidioidomycosis, or blastomycosis) are common. Ask your doctor if you are unsure whether these fungal infections are common in the area where you have lived or travelled.
Tumours and lymphoma
Inform your doctor if you have or have ever had lymphoma (a type of blood cancer) or other types of tumours before Simponi is administered to you.

  • Your risk of developing lymphoma or another type of tumour may increase if you use Simponi or other TNF blockers.
  • Patients with severe rheumatoid arthritis or other inflammatory diseases who have had the disease for a long time may have a higher than average risk of developing lymphoma.
  • Cases of tumours, including unusual types, sometimes fatal, have been reported in children and adolescents taking TNF blocker medicines.
  • In rare cases, a specific and serious type of lymphoma called hepatosplenic T-cell lymphoma has been observed in patients taking other TNF blockers. Most of these patients were adolescent or young adult males. This type of cancer usually led to death. Almost all of these patients had also received medicines known as azathioprine or 6-mercaptopurine. Inform your doctor if you are taking azathioprine or 6-mercaptopurine with Simponi.
  • Patients with severe persistent asthma, chronic obstructive pulmonary disease (COPD), or heavy smokers may have an increased risk of cancer with treatment with Simponi. If you have severe persistent asthma, COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate.
  • Some patients treated with golimumab have developed certain types of skin cancer. If any changes in the appearance of your skin or skin growths appear during or after therapy, inform your doctor.

Heart failure
Inform your doctor immediately if you notice new symptoms of heart failure or worsening of existing symptoms. Symptoms of heart failure include shortness of breath or swelling of the feet.

  • Cases of new-onset or worsening congestive heart failure have been reported with TNF blockers, including Simponi. Some of these patients died.
  • If you have mild heart failure and are treated with Simponi, your doctor will monitor you closely.

Nervous system disorders
Inform your doctor immediately if you have ever been diagnosed with or develop symptoms of a demyelinating disease such as multiple sclerosis. Symptoms may include changes in vision, weakness in arms and legs, numbness, or tingling in any part of the body. Your doctor will decide whether Simponi should be administered to you.
Surgery or dental procedures

  • Inform your doctor if you are scheduled to undergo any surgery or dental procedures.
  • Inform the surgeon or dentist performing the procedure that you are being treated with Simponi, and show them your Patient Card.

Autoimmune diseases
Inform your doctor if you develop symptoms of a disease called lupus. Symptoms include a persistent skin rash, fever, joint pain, and fatigue.

  • In rare cases, people treated with TNF blockers have developed lupus.

Blood disorders
In some patients, the body may not produce enough blood cells that help the body fight infections or help stop bleeding. If you develop persistent fever of unknown origin, bruising easily, bleeding easily, or appear very pale, contact your doctor immediately. Your doctor may decide to discontinue treatment.
If you are unsure whether any of the conditions listed above may apply to you, speak with your doctor or pharmacist before using Simponi.
Vaccinations
Inform your doctor if you have recently been vaccinated or if you are planning to be vaccinated.

  • You must not receive certain vaccines (live vaccines) while being treated with Simponi.
  • Some vaccinations may cause infections. If you received Simponi while pregnant, your baby may have an increased risk of contracting such an infection for approximately six months after your last dose during pregnancy. It is important to inform the paediatrician and other healthcare providers about your use of Simponi so they can decide when your baby should receive any vaccine.

Talk to your child’s doctor about vaccinations for your child. If possible, your child should be up to date with all vaccinations before using Simponi.
Therapeutic infectious agents
Talk to your doctor if you have recently taken or are planning to take treatment with a therapeutic infectious agent (such as BCG instillation used for cancer treatment).
Allergic reactions
Inform your doctor immediately if you develop symptoms of an allergic reaction after treatment with Simponi. Symptoms of an allergic reaction may include swelling of the face, lips, mouth, or throat that may cause difficulty swallowing or breathing, skin rash, hives, or swelling of hands, feet, and ankles.

  • Some of these reactions may be serious or, rarely, life-threatening.
  • Some of these reactions occurred after the first dose of Simponi.

Children
Simponi is not recommended for children under 2 years of age with polyarticular juvenile idiopathic arthritis, as it has not been studied in this population.
Other medicines and Simponi

  • Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including any other medicines used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
  • You must not take Simponi with medicines containing the active substances anakinra or abatacept. These medicines are used to treat rheumatic diseases.
  • Inform your doctor or pharmacist if you are taking any other medicine that affects the immune system.
  • You cannot receive certain vaccines (live vaccines) while using Simponi.

If you are unsure whether any of the conditions listed above may apply to you, speak with your doctor or pharmacist before using Simponi.
Pregnancy and breastfeeding
Talk to your doctor before using Simponi if:

  • You are pregnant or planning to become pregnant while using Simponi. Limited information is available on the effects of this medicine in pregnant women. If you need to be treated with Simponi, you should avoid pregnancy by using an adequate method of contraception during treatment and for at least 6 months after the last injection of Simponi. Simponi should be used during pregnancy only if strictly necessary for you.
  • At least 6 months must have passed since your last Simponi treatment before breastfeeding. You must stop breastfeeding if Simponi is to be administered to you.
  • If you received Simponi during pregnancy, your baby may have an increased risk of contracting an infection. It is important to inform the paediatrician and other healthcare providers about your use of Simponi before your baby receives any vaccine (for more information, see the section on vaccinations). If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Simponi has a minor influence on the ability to drive and use machines. After using Simponi, dizziness may occur. In this case, do not drive or use tools or machines.
Simponi contains latex, sorbitol, and polysorbate
Latex sensitivity
A part of the pre-filled pen, the cap covering the needle, contains latex. Since latex can cause severe allergic reactions, inform your doctor before using Simponi if you or your caregiver are allergic to latex.
Sorbitol intolerance
This medicine contains 20.5 mg of sorbitol (E420) in each pre-filled pen.
Polysorbate 80
This medicine contains 0.075 mg of polysorbate 80 (E433) per pre-filled pen. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Simponi

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, you must consult your doctor or pharmacist.
How much Simponi is administered

Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis and
non-radiographic axial spondyloarthritis:

  • The recommended dose is 50 mg (the content of 1 pre-filled pen) administered once a month, on the same day each month.
  • Consult your doctor before taking the fourth dose. Your doctor will decide whether you should continue treatment with Simponi. o If you weigh more than 100 kg, the dose may be increased to 100 mg (the content of 2 pre-filled pens), administered once a month, always on the same day each month.

Polyarticular juvenile idiopathic arthritis in children aged 2 years and older:

  • For patients weighing at least 40 kg, the recommended dose is 50 mg administered once a month, on the same day each month. For patients weighing less than 40 kg, a 45 mg/0.45 mL pre-filled pen is available. Your doctor will tell you the correct dose to use.
  • Consult your doctor before taking the fourth dose. Your doctor will decide whether you should continue treatment with Simponi.

Ulcerative colitis

  • The table below shows how you will generally use this medicine.
Initial treatmentAn initial dose of 200 mg (the contents of 4 pre-filled pens) followed by 100 mg (the contents of 2 pre-filled pens) after 2 weeks.
Maintenance treatment
  • In patients weighing less than 80 kg, 50 mg (the contents of 1 pre-filled pen) 4 weeks after their last treatment, then subsequently every 4 weeks. The doctor may decide to prescribe 100 mg (the contents of 2 pre-filled pens), based on the effect that Simponi has on the patient.
    -In patients weighing 80 kg or more, 100 mg (the contents of 2 pre-filled pens) 4 weeks after their last treatment, then subsequently every 4 weeks.

How Simponi is administered

  • Simponi is administered by injection under the skin (subcutaneously).
  • Initially, your doctor or nurse will inject Simponi for you. However, you and your doctor may decide that you can self-inject Simponi or that you can inject it for your child. In this case, you will be instructed on how to inject Simponi. Speak with your doctor if you have any questions about self-administering an injection. At the end of this leaflet, you will find detailed “Instructions for use”.

If you use more Simponi than you should
If you have used or have been given too much Simponi (by injecting too much in a single
administration, or using it too frequently), inform your doctor or pharmacist immediately.
Always take the outer packaging and this leaflet with you, even if they are empty.
If you forget to use Simponi
If you forget to use Simponi on the scheduled day, inject the missed dose as soon as you remember.
Do not use a double dose to make up for the forgotten dose.
When to inject the next dose:

  • If the delay is less than 2 weeks, inject the missed dose as soon as you remember and continue following the original schedule.
  • If the delay is more than 2 weeks, inject the missed dose as soon as you remember, then inform your doctor or pharmacist and ask when you should take the next dose.

If you have any doubts about what to do, consult your doctor or pharmacist.
If you stop using Simponi
If you are considering stopping treatment with Simponi, speak to your doctor or pharmacist first.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some patients may experience serious side effects that may require medical treatment. The risk of certain side effects is higher with the 100 mg dose compared to the 50 mg dose. Side effects may also occur several months after the last injection.

Contact your doctor immediately if you notice any of the following serious side effects of Simponi, including:

  • Allergic reactions, which may be severe or, rarely, potentially life-threatening (rare). Symptoms of an allergic reaction may include swelling of the face, lips, mouth or throat, which may cause difficulty swallowing or breathing, rash, hives, swelling of the hands, feet or ankles. Some of these reactions occurred after the first administration of Simponi.
  • Serious infections (including tuberculosis, bacterial infections such as severe blood infections and pneumonia, serious fungal infections and other opportunistic infections) (common). Symptoms of infection may include fever, fatigue, cough (persistent), shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, sores, dental problems and burning sensation when urinating.
  • Reactivation of hepatitis B virus if you are a carrier or have previously had hepatitis B (rare). Symptoms may include yellowing of the skin and eyes, dark brown urine, pain in the right side of the abdomen, fever, feeling unwell, malaise and extreme tiredness.
  • Nervous system disorders such as multiple sclerosis (rare). Symptoms of nervous system disorders may include changes in vision, weakness in arms or legs, numbness or tingling in any part of the body.
  • Lymph node cancer (lymphoma) (rare). Symptoms of lymphoma may include swollen lymph nodes, weight loss, or fever.
  • Heart failure (rare). Symptoms of heart failure may include shortness of breath or swelling of the feet.
  • Signs of immune system disorders called:
    • Lupus (rare). Symptoms may include joint pain or a rash on the cheeks or arms that is sensitive to sunlight.
    • Sarcoidosis (rare). Symptoms may include a persistent cough, shortness of breath, chest pain, fever, swollen lymph nodes, weight loss, skin rashes and blurred vision.
    • Swelling of small blood vessels (vasculitis) (rare). Symptoms may include fever, headache, weight loss, night sweats, rash and nerve problems such as numbness and tingling.
  • Skin cancer (not common). Symptoms of skin cancer may include changes in the appearance of the skin or skin growths.
  • Blood disorders (common). Symptoms of blood disorders may include a fever that does not go away, a strong tendency to bruise or bleed easily, or looking very pale.
  • Blood cancer (leukaemia) (rare). Symptoms of leukaemia may include fever, feeling tired, frequent infections, bruising and night sweats.

Contact your doctor immediately if you notice any of the symptoms listed above.

The following additional side effects have been observed with Simponi:

Very common side effects (may affect more than 1 in 10 people):

  • Upper respiratory tract infections, sore throat or hoarseness, cold

Common side effects (may affect up to 1 in 10 people):

  • Abnormal liver function tests (increased liver enzymes), detected during blood tests performed by your doctor
  • Dizziness
  • Headache
  • Numbness or tingling sensation
  • Superficial fungal infections
  • Abscess
  • Bacterial infections (such as cellulitis)
  • Reduction in red blood cells
  • Reduction in white blood cells
  • Positive blood test for lupus
  • Allergic reactions
  • Indigestion
  • Stomach pain
  • Feeling unwell (nausea)
  • Influenza
  • Bronchitis
  • Sinus infection
  • Oral herpes
  • High blood pressure
  • Fever
  • Asthma, shortness of breath, wheezing
  • Stomach and intestinal disorders including inflammation of the lining of the stomach and colon, which may cause fever
  • Pain and ulcers in the mouth
  • Injection site reactions (including redness, hardening, pain, bruising, itching, tingling and irritation)
  • Hair loss
  • Skin rash and itching
  • Difficulty sleeping
  • Depression
  • Feeling weak
  • Bone fractures
  • Chest pain

Uncommon side effects (may affect up to 1 in 100 people):

  • Kidney infection
  • Cancer, including skin cancer and non-cancerous swellings or small masses, including moles
  • Skin blisters
  • Severe infection throughout the body (sepsis), sometimes including low blood pressure (septic shock)
  • Psoriasis (including on palms of the hands and/or soles of the feet and/or in the form of skin blisters)
  • Reduction in platelets
  • Combined reduction in platelets, red blood cells and white blood cells
  • Thyroid disorders
  • Increased blood sugar levels
  • Increased blood cholesterol levels
  • Balance disorders
  • Vision disorders
  • Inflamed eye (conjunctivitis)
  • Eye allergy
  • Sensation of irregular heartbeat
  • Narrowing of blood vessels in the heart
  • Blood clots
  • Flushing
  • Constipation
  • Chronic lung inflammation
  • Acid reflux
  • Gallstones
  • Liver disorders
  • Breast disorders
  • Menstrual disorders

Rare side effects (may affect up to 1 in 1,000 people):

  • Inability of the bone marrow to produce blood cells
  • Severe reduction in the number of white blood cells
  • Joint or surrounding tissue infection
  • Poor wound healing
  • Inflammation of blood vessels in internal organs
  • Leukaemia
  • Melanoma (a type of skin tumour)
  • Merkel cell carcinoma (a type of skin tumour)
  • Lichenoid reactions (itchy purple-red rash and/or white-grey thread-like lines on mucous membranes)
  • Skin peeling
  • Immunological disorders that may affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
  • Pain and discolouration in fingers or toes
  • Taste disturbances
  • Bladder disorders
  • Kidney disorders
  • Inflammation of blood vessels in the skin causing a rash

Side effects with unknown frequency:

  • A rare blood tumour affecting mainly young people (hepatosplenic T-cell lymphoma)
  • Kaposi’s sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi’s sarcoma most commonly presents with purple lesions on the skin
  • Worsening of a condition called dermatomyositis (which presents as a rash associated with muscle weakness)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Simponi

  • Keep this medicine out of the sight and reach of children.

  • Do not use this medicine after the expiry date stated on the label and the carton after "Exp". The expiry date refers to the last day of that month.

  • Store in a refrigerator (2 °C–8 °C). Do not freeze.

  • Keep the pre-filled pen in the outer packaging to protect the medicine from light.

  • This medicine can also be stored outside the refrigerator at temperatures up to a maximum of 25 °C for a single period of up to 30 days, but not beyond the original expiry date printed on the carton. Write the new expiry date on the carton, indicating day/month/year (no more than 30 days after the medicine was removed from the refrigerator).
    Do not return this medicine to the refrigerator once it has reached room temperature.
    Dispose of this medicine if not used by the new expiry date or by the printed expiry date on the carton, whichever comes first.

  • Do not use this medicine if you notice that the liquid is not clear to pale yellow, appears cloudy, or contains foreign particles.

  • Do not dispose of any medicine via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Simponi contains
The active substance is golimumab. One pre-filled pen containing 0.5 mL delivers 50 mg of golimumab.
The other ingredients are sorbitol (E420), histidine, histidine monohydrochloride monohydrate, polysorbate 80 (E433), and water for injections. For further information on sorbitol (E420) and polysorbate 80 (E433), see section 2.

Description of the appearance of Simponi and contents of the pack
Simponi is supplied as an injectable solution in a single-use pre-filled pen. Simponi is available in packs containing 1 pre-filled pen and multipacks containing 3 (3 packs of 1) pre-filled pens. Not all pack sizes may be marketed.
The solution is from clear to slightly opalescent (pearl-like sheen), colourless to pale yellow, and may contain a few small translucent or white protein particles. Do not use Simponi if the solution has changed colour, is cloudy, or contains visible foreign particles.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB "JOHNSON & JOHNSON"
Tel/Tél: 0800 93 377 Tel: +370 5 278 68 88
[email protected] [email protected]

България Luxembourg/Luxemburg
„Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Тел.: +359 2 489 94 00 Tél/Tel: 800 29 504
[email protected] [email protected]

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD
Tlf.: +45 4594 8282 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: 0800 242 42 42
[email protected] [email protected]

Eesti Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]

Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε. Tel: +43 1 610 300
Tηλ: +30 210 80 90 000

España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.: +48 22 237 60 00
[email protected]

France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected] [email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor ehf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]

Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Τηλ: +357 22 207 700 Tfn: +46 8 626 50 00
[email protected]

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561
[email protected]

More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

INSTRUCTIONS FOR USE

If you wish to self-inject Simponi, you must be trained by a healthcare professional on how to
prepare and administer the injection yourself. If you have not been trained, inform your doctor,
nurse, or pharmacist to schedule a training session.
These instructions include:

  1. Preparation for using the pre-filled pen
  2. Selection and preparation of the injection site
  3. Administration of the medicine
  4. After the injection

The following figure (see Figure 1) shows what the pre-filled pen “SmartJect” looks like.

Technical diagram of a medical device with labels indicating the green safety sleeve, viewing window, and raised part of the button Diagram with labels indicating the cap, safety seal, transparent cover, and expiration date of a medical container

Figure 1

1. Preparation for using the pre-filled pen

  • Never shake the pre-filled pen.
  • Do not remove the cap from the pre-filled pen until immediately before administering the injection.
  • If removed, do not reinsert the cap into the pre-filled pen to avoid bending the needle.

Check the number of pre-filled pens
Check the pre-filled pens to ensure that

  • the number of pre-filled pens and the dosage are correct.
    • If your dose is 50 mg, you will use one 50 mg pre-filled pen.
    • If your dose is 100 mg, you will use two 50 mg pre-filled pens and must administer two injections. Choose two different injection sites for these injections (e.g., one injection in the right thigh and the other in the left thigh) and perform the injections one after the other.
    • If your dose is 200 mg, you will use four 50 mg pre-filled pens and must administer four injections. Choose different injection sites for these injections and perform the injections one after the other.

Check the expiration date

  • Check the expiration date printed or written on the box.
  • Check the expiration date (indicated by “Exp.”) on the pre-filled pen.
  • Do not use the pre-filled pen if the expiration date has passed. The printed expiration date refers to the last day of the month. Contact your doctor or pharmacist for assistance.

Check the security seal

  • Check the security seal around the cap of the pre-filled pen.
  • Do not use the pre-filled pen if the seal is broken. Contact your doctor or pharmacist.

Wait 30 minutes to allow the pre-filled pen to reach room temperature

  • To ensure proper injection, leave the pre-filled pen at room temperature outside the box for 30 minutes, out of the reach of children.
  • Do not warm the pre-filled pen in any other way (e.g., do not warm it in a microwave or in hot water).
  • Do not remove the cap from the pre-filled pen while allowing it to reach room temperature.

Prepare the remaining supplies

  • While waiting, prepare the remaining supplies, including an alcohol wipe, a cotton ball or gauze, and a sharps container.

Check the liquid in the pre-filled pen

  • Look through the inspection window and make sure that the liquid in the pre-filled pen is from clear to slightly opalescent (pearl-like sheen) and colorless to pale yellow. The solution may be used if it contains a few small translucent or white protein particles.
  • You may also notice a small air bubble, which is normal.
  • Do not use the pre-filled pen if the liquid is not the correct color, if it is cloudy, or if it contains larger particles. In this case, inform your doctor or pharmacist.

2. Choosing and preparing the injection site (see Figure 2)

  • You may inject the medicine in the central front area of the thighs.
  • You may use the abdomen below the navel, except for an area of approximately 5 cm directly below the navel.
  • Do not inject in areas where the skin is tender, bruised, red, scaly, hard, or has scars or stretch marks.
  • If multiple injections are required for a single dose, administer the injections at different injection sites.
Schematic drawing of torso and legs of a person with gray areas indicating injection sites on

Figure 2

Warning symbol with a white exclamation mark inside

DO NOT inject in the arm to avoid malfunction of the pre-filled pen and/or accidental injuries.
Hand washing and cleaning the injection site

  • Wash your hands thoroughly with soap and warm water.
  • Rub the injection site with an alcohol swab.
  • Allow the skin to dry completely before injecting. Do not blow or fan the cleaned area.
  • Do not touch this area before administering the injection.

3. Medication Injection

  • Remove the cap only when you are ready to inject the medication.
  • The medication must be injected within 5 minutes after removing the cap.

Remove the cap (Figure 3)

  • When ready for injection, gently twist the cap to break the safety seal.
  • Pull the cap straight off and dispose of it after injection.
  • Do not reattach the cap, as it may damage the needle inside the pre-filled pen.
  • Do not use the pre-filled pen if it has been dropped without the cap. In this case, contact your doctor or pharmacist.
Two hands rotating a medical device clockwise and two arrows indicating the separation movement between the two parts of the device

Figure 3
Press the pre-filled pen against the skin (see Figures 4 and 5) without pinching the skin

A hand holds a medical device vertically at 90 degrees with an enlargement showing the green safety sleeve

Figure 4

  • Hold the pre-filled pen comfortably in one hand above the blue button.
  • Ensure that the green safety sleeve is stable and pressed as flat as possible against the skin. If the pre-filled pen is not stable during injection, the needle may bend.
  • DO NOT pinch the skin to avoid accidental needle injuries.
  • DO NOT touch or press the blue button while positioning the pre-filled pen on the skin.
A hand holds a medical device vertically at 90 degrees relative to the surface with an enlargement of the lower tip

Figure 5

  • Press the open end of the pre-filled pen perpendicularly (at a 90-degree angle) against the skin. Apply sufficient pressure to make the green safety sleeve slide upward into the transparent cover. Only the wider part of the green safety sleeve remains outside the transparent cover.
  • DO NOT press the blue button until the safety sleeve has fully slid into the transparent cover. If you press the blue button before the safety sleeve has slid in, the pen may not function properly.
  • Inject without pinching the skin.

Press the button to inject (see Figures 6 and 7)

Illustration of a medical device with an arrow indicating the side button to press with the text 'Press button here' Two hands holding a cylindrical medical device with a finger pressing a button and the text '1st CLICK' next to the base

Figure 6 Figure 7

  • Continue pressing the pre-filled pen firmly against the skin. Use your other hand to press the raised portion of the blue button to start the injection. Do not press the button unless the pre-filled pen is pressed firmly against the skin and the safety sleeve has slid into the transparent cover.
  • Once pressed, the button will remain in this position so you do not need to keep applying pressure.
  • If the button feels difficult to press, do not press harder. Release the button, lift the pre-filled pen, and start again. Make sure no pressure is applied to the button until the green safety sleeve is fully pressed against the skin, then press the raised portion of the button.
  • You will hear a loud “click” – do not be alarmed. The first “click” indicates that the needle has been inserted and the injection has started. At this point, you may or may not feel the needle entering the skin.

Do not lift the pre-filled pen from the skin. If you lift the pre-filled pen from the skin, you may not have injected the full dose of medication.
Continue pressing until you hear a second “click” (see Figure 8). This usually takes 3 to 6 seconds, but it may take up to 15 seconds to hear the second “click”.

Black and white drawing of two hands holding a medical device with the thumb pressing a button near the text '2nd CLICK'

Figure 8

  • Keep holding the pre-filled pen against the skin until you hear a second “click” (indicating that the injection is complete and the needle has retracted into the pre-filled pen).
  • Lift the pre-filled pen away from the injection site.
  • Note: If you do not hear the second “click”, wait 15 seconds from the moment you first pressed the button, then remove the autoinjector from the injection site.

4. After the injection

Use a cotton ball or gauze

  • There may be a small amount of blood or liquid at the injection site. This is normal.
  • You may press a cotton ball or gauze over the injection site for 10 seconds.
  • If needed, you may cover the injection site with a small adhesive bandage.
  • Do not rub the skin.

Check the window – a yellow indicator confirms successful delivery (see
Figure 9)

  • The yellow indicator is connected to the plunger of the pre-filled pen. If the yellow indicator does not appear in the window, the plunger has not advanced properly and the injection has not been administered.
  • The yellow indicator will fill approximately half of the viewing window. This is normal.
  • Speak with your doctor or pharmacist if the yellow indicator is not visible in the window or if you suspect you may not have received a complete dose. Do not administer a second dose without first talking to your doctor.
Technical drawing of a medical device with a black arrow pointing to a yellow indicator visible through a transparent window

Figure 9
Dispose of the pre-filled pen (see Figure 10)

  • Immediately place the pen into a sharps disposal container. When the container is full, make sure to dispose of it according to the instructions provided by your doctor or nurse.

If you think something did not work properly during the injection or if you are unsure,
speak with your doctor or pharmacist.

A hand holds a medical device ready to be placed into a biohazard waste container with biohazard symbol and the word BIOHAZARD

Figure 10

Package leaflet: Information for the user

Simponi 50 mg solution for injection in pre-filled syringe

golimumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Your doctor will provide you with a Patient Information Card containing important safety information that you should be aware of before and during treatment with Simponi.
Contents of this leaflet

  1. What Simponi is and what it is used for
  2. What you need to know before using Simponi
  3. How to use Simponi
  4. Possible side effects
  5. How to store Simponi
  6. Contents of the pack and other information

1. What Simponi is and what it is used for

Simponi contains an active substance called golimumab.
Simponi belongs to a group of medicines known as “TNF blockers”. It is used in adults
for the treatment of the following inflammatory diseases:

  • Rheumatoid arthritis
  • Psoriatic arthritis
  • Axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis
  • Ulcerative colitis

Simponi is used in children aged 2 years and older for the treatment of polyarticular juvenile idiopathic arthritis, and in children aged 2 years and older with a body weight above 15 kg for the treatment of pediatric ulcerative colitis.
Simponi works by blocking the action of a protein called “tumour necrosis factor alpha” (TNF-α). This protein is involved in inflammatory processes in the body, and by blocking it, inflammation in the body can be reduced.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints. If you have active rheumatoid arthritis, you will initially be treated with other medicines. If you do not respond adequately to these medicines, you will be treated with Simponi in combination with another medicine called methotrexate to:

  • Reduce the signs and symptoms of the disease.
  • Slow down damage to bones and joints.
  • Improve physical function.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory skin disease. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you will be treated with Simponi to:

  • Reduce the signs and symptoms of the disease.
  • Slow down damage to bones and joints.
  • Improve physical function.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis
Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory diseases of the spine. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you will be treated with Simponi to:

  • Reduce the signs and symptoms of the disease.
  • Improve physical function.

Ulcerative colitis (in adults and pediatric)
Ulcerative colitis is an inflammatory bowel disease. If you have ulcerative colitis, you will first be given other medicines. If you do not respond adequately to these medicines, Simponi will be administered to treat your disease.

Polyarticular juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis is an inflammatory disease that causes pain and swelling in the joints in children. If you have polyarticular juvenile idiopathic arthritis, you will first be given other medicines. If you do not respond adequately to these medicines, you will be given Simponi in combination with methotrexate to treat the disease.

2. What you should know before using Simponi

Do not use Simponi

  • If you are allergic (hypersensitive) to golimumab or to any of the other ingredients of this medicine (listed in section 6).
  • If you have tuberculosis (TB) or any other serious infection.
  • If you have moderate or severe heart failure.

If you are unsure whether any of the above conditions may apply to you, speak with your doctor, pharmacist, or nurse before using Simponi.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Simponi.
Infections
Tell your doctor immediately if you have ever had, or if you develop symptoms of infection during or after treatment with Simponi. Symptoms of infection include fever, cough, shortness of breath, flu-like symptoms, diarrhoea, wounds, dental problems, or a burning sensation when urinating.

  • You may be more likely to get infections while using Simponi.
  • Infections may progress more quickly and be more severe. In addition, past infections may recur.

Tuberculosis (TB)
Tell your doctor immediately if you notice symptoms of TB during treatment. Symptoms of TB include a persistent cough, weight loss, feeling tired, fever, or night sweats.

  • Cases of TB have been reported in patients treated with Simponi, rarely even in patients who had previously been treated for TB. Your doctor will perform tests to assess whether you have TB. Your doctor will record these tests in the Patient Record Card.
  • It is very important that you inform your doctor if you have ever had TB or if you have been in close contact with someone who has or has had TB.
  • If your doctor believes you are at risk of TB, you may be treated with TB medications before starting Simponi.

Hepatitis B virus (HBV)

  • Inform your doctor if you are a carrier of, or have or have had hepatitis B, before Simponi is administered to you.
  • Inform your doctor if you think you may be at risk of contracting hepatitis B.
  • Your doctor must perform tests to determine whether you have hepatitis B.
  • Treatment with TNF blockers such as Simponi may cause reactivation of the hepatitis B virus in patients who are carriers of this virus, which in some cases may lead to death.

Invasive fungal infections
Tell your doctor immediately if you have lived in or travelled to an area where fungal infections that can affect the lungs or other parts of the body are common (called histoplasmosis, coccidioidomycosis, or blastomycosis). Ask your doctor if you are unsure whether these fungal infections are common in the area where you have lived or travelled.
Tumours and lymphoma
Inform your doctor if you have or have ever had lymphoma (a type of blood cancer) or other types of cancer before Simponi is administered to you.

  • Your risk of developing lymphoma or another type of cancer may increase if you use Simponi or other TNF blockers.
  • Patients with severe rheumatoid arthritis or other inflammatory diseases, who have had the disease for a long time, may have a higher than average risk of developing lymphoma.
  • Cases of cancer, including unusual types, sometimes fatal, have been reported in children and adolescents treated with TNF blocker medicines.
  • Rarely, a specific and serious type of lymphoma called hepatosplenic T-cell lymphoma has been observed in patients taking other TNF blockers. Most of these patients were adolescent or young adult males. This type of cancer has usually been fatal. Almost all of these patients had also received medications known as azathioprine or 6-mercaptopurine. Inform your doctor if you are taking azathioprine or 6-mercaptopurine with Simponi.
  • Patients with severe persistent asthma, chronic obstructive pulmonary disease (COPD), or regular smokers may have an increased risk of cancer with Simponi treatment. If you have severe persistent asthma, COPD, or are a regular smoker, discuss with your doctor whether treatment with a TNF blocker is appropriate.
  • Some patients treated with golimumab have developed certain types of skin cancer. If any changes in the appearance of your skin or skin growths appear during or after therapy, inform your doctor.

Heart failure
Tell your doctor immediately if you notice new symptoms of heart failure or worsening of existing symptoms. Symptoms of heart failure include shortness of breath or swelling of the feet.

  • Cases of new-onset congestive heart failure or worsening of existing heart failure have been reported with TNF blockers, including Simponi. Some of these patients have died.
  • If you have mild heart failure and are treated with Simponi, your doctor will monitor you closely.

Nervous system disorders
Tell your doctor immediately if you have ever been diagnosed with, or if you develop symptoms of, a demyelinating disease such as multiple sclerosis. Symptoms may include changes in vision, weakness in arms and legs, numbness, or tingling in any part of the body. Your doctor will decide whether Simponi should be administered to you.
Surgery or dental procedures

  • Inform your doctor if you are scheduled for any surgery or dental procedures.
  • Inform the surgeon or dentist performing the procedure that you are being treated with Simponi, and show them the Patient Record Card.

Autoimmune diseases
Inform your doctor if you develop symptoms of a disease called lupus. Symptoms include a persistent skin rash, fever, joint pain, and fatigue.

  • Rarely, people treated with TNF blockers have developed lupus.

Blood disorders
In some patients, the body may not produce enough blood cells that help fight infections or help stop bleeding. If you develop persistent fever of unknown origin, bruising easily, or bleeding easily, or if you become very pale, call your doctor immediately. Your doctor may decide to stop treatment.
If you are unsure whether any of the above conditions may apply to you, speak with your doctor or pharmacist before using Simponi.
Vaccinations
Inform your doctor if you have recently been vaccinated or if you plan to be vaccinated.

  • You must not receive certain vaccines (live vaccines) while being treated with Simponi.
  • Some vaccinations may cause infections. If you received Simponi during pregnancy, your baby may have an increased risk of contracting such an infection for approximately six months after your last dose during pregnancy. It is important to inform your baby’s paediatrician and other healthcare providers about your use of Simponi so they can decide when your baby should receive any vaccine.

Talk to your baby’s doctor about vaccinations for your baby. If possible, your baby should be up to date with all vaccinations before you use Simponi.
Therapeutic infectious agents
Talk to your doctor if you have recently taken or plan to take treatment with a therapeutic infectious agent (such as BCG instillation used to treat cancer).
Allergic reactions
Tell your doctor immediately if you develop symptoms of an allergic reaction after treatment with Simponi. Symptoms of an allergic reaction may include swelling of the face, lips, mouth, or throat that may cause difficulty swallowing or breathing, skin rash, hives, or swelling of hands, feet, and ankles.

  • Some of these reactions may be serious or, rarely, life-threatening.
  • Some of these reactions have occurred after the first dose of Simponi.

Children
Simponi is not recommended for children under 2 years of age with polyarticular juvenile idiopathic arthritis or paediatric ulcerative colitis, as it has not been studied in these populations.
Other medicines and Simponi

  • Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including any other medicines used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
  • You must not take Simponi with medicines containing the active substances anakinra or abatacept. These medicines are used to treat rheumatic diseases.
  • Inform your doctor or pharmacist if you are taking any other medicine that affects the immune system.
  • You cannot receive certain vaccines (live vaccines) while using Simponi.

If you are unsure whether any of the above conditions may apply to you, speak with your doctor or pharmacist before using Simponi.
Pregnancy and breastfeeding
Talk to your doctor before using Simponi if:

  • You are pregnant or planning to become pregnant during treatment with Simponi. Limited information is available on the effects of this medicine in pregnant women. If you are to be treated with Simponi, you must avoid pregnancy by using an appropriate method of contraception during treatment and for at least 6 months after the last injection of Simponi. Simponi should be used during pregnancy only if strictly necessary for you.
  • Breastfeeding must be avoided for at least 6 months after your last Simponi treatment. You must stop breastfeeding if Simponi is to be administered to you.
  • If you received Simponi during pregnancy, your baby may have an increased risk of infection. It is important to inform your baby’s paediatrician and other healthcare providers about your use of Simponi before your baby receives any vaccine (for more information, see the section on vaccinations). If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Simponi has a minor influence on the ability to drive and use tools or machines. After using Simponi, dizziness may occur. If this happens, do not drive or use tools or machines.
Simponi contains latex, sorbitol, and polysorbate
Latex sensitivity
A part of the pre-filled syringe, the needle cap, contains latex. Since latex may cause severe allergic reactions, inform your doctor before using Simponi if you or your caregiver is allergic to latex.
Sorbitol intolerance
This medicine contains 20.5 mg of sorbitol (E420) in each pre-filled syringe.
Polysorbate 80
This medicine contains 0.075 mg of polysorbate 80 (E433) per pre-filled syringe. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Simponi

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, you should consult your doctor or pharmacist.
How much Simponi is administered
Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis and
non-radiographic axial spondyloarthritis:

  • The recommended dose is 50 mg (the content of 1 pre-filled syringe) administered once a month, on the same day each month.
  • Consult your doctor before taking the fourth dose. Your doctor will decide whether you should continue treatment with Simponi. If you weigh more than 100 kg, the dose may be increased to 100 mg (the content of 2 pre-filled syringes), administered once a month, always on the same day each month.

Polyarticular juvenile idiopathic arthritis:

  • In patients weighing at least 40 kg, the recommended dose is 50 mg administered once a month, on the same day each month. For patients weighing less than 40 kg, a 45 mg/0.45 ml pre-filled pen is available. Your doctor will tell you the correct dose to use.
  • Consult your doctor before taking the fourth dose. Your doctor will decide whether you should continue treatment with Simponi.

Ulcerative colitis in adults

  • The table below shows how you will generally use this medicine.
Initial treatmentAn initial dose of 200 mg (the contents of 4 pre-filled syringes) followed by 100 mg (the contents of 2 pre-filled syringes) after 2 weeks.
Maintenance treatment
  • In patients weighing less than 80 kg, 50 mg (the contents of 1 pre-filled syringe) 4 weeks after their last treatment, then subsequently every 4 weeks. Your doctor may decide to prescribe 100 mg (the contents of 2 pre-filled syringes), based on the effect that Simponi has on you.
    -In patients weighing 80 kg or more, 100 mg (the contents of 2 pre-filled syringes) 4 weeks after their last treatment, then subsequently every 4 weeks.

Pediatric ulcerative colitis in children aged 2 years and older weighing at least 15 kg:

  • The following table shows how you will use this medicine.
Initial treatment
  • In patients weighing at least 15 kg but less than 40 kg, an initial dose of 100 mg (the contents of 2 pre-filled syringes), followed by 50 mg (the contents of 1 pre-filled syringe) 2 weeks later.
    -In patients weighing 40 kg or more, an initial dose of 200 mg (the contents of 4 pre-filled syringes), followed by 100 mg (the contents of 2 pre-filled syringes) 2 weeks later.
Maintenance treatment
  • In patients weighing at least 15 kg but less than 40 kg, 50 mg (the contents of 1 pre-filled syringe) 4 weeks after the last dose, then every 4 weeks thereafter.
    -In patients weighing at least 40 kg but less than 80 kg, 100 mg (the contents of 2 pre-filled syringes) 4 weeks after the last dose, then every 4 weeks thereafter.
    -In patients weighing 80 kg or more, 100 mg (the contents of 2 pre-filled syringes) 4 weeks after the last dose, then every 4 weeks thereafter.

Your doctor will tell you the correct dose to use.
How Simponi is administered

  • Simponi is administered by injection under the skin (subcutaneously).
  • Initially, your doctor or nurse will inject Simponi for you. However, you and your doctor may decide that you can self-inject Simponi or that you can inject it for your child. In this case, you will be instructed on how to inject Simponi. Talk to your doctor if you have any questions about self-administering an injection. At the end of this leaflet, you will find detailed “Instructions for use”.

If you use more Simponi than you should
If you have used or have been given too much Simponi (by injecting too much in a single
administration, or by using it too frequently), inform your doctor or pharmacist immediately.
Always take the outer packaging and this leaflet with you, even if they are empty.
If you forget to use Simponi
If you forget to use Simponi on the scheduled day, inject the missed dose as soon as you remember.
Do not use a double dose to make up for the forgotten dose.
When to inject the next dose:

  • If the delay is less than 2 weeks, inject the missed dose as soon as you remember and continue following the original schedule.
  • If the delay is more than 2 weeks, inject the missed dose as soon as you remember and inform your doctor or pharmacist, and ask when you should take the next dose.

If you have any doubts about what to do, consult your doctor or pharmacist.
If you stop treatment with Simponi
If you are considering stopping treatment with Simponi, speak to your doctor or pharmacist first.
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Some patients may experience serious side effects that may require medical treatment. The risk of certain side effects is higher with the 100 mg dose compared to the 50 mg dose. Side effects may also occur several months after the last injection.

Tell your doctor immediately if you notice any of the following serious side effects of Simponi, including:

  • Allergic reactions which may be severe, or rarely, potentially life-threatening (rare). Symptoms of an allergic reaction may include swelling of the face, lips, mouth or throat, which may cause difficulty swallowing or breathing, rash, hives, swelling of hands, feet or ankles. Some of these reactions occurred after the first dose of Simponi.
  • Serious infections (including TB, bacterial infections such as severe blood infections and pneumonia, serious fungal infections and other opportunistic infections) (common). Symptoms of infection may include fever, tiredness, cough (persistent), shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, dental problems and burning sensation when urinating.
  • Reactivation of hepatitis B virus if you are a carrier or have previously had hepatitis B (rare). Symptoms may include yellowing of the skin and eyes, dark brown urine, pain in the right side of the abdomen, fever, feeling unwell, malaise and severe tiredness.
  • Nervous system disorders such as multiple sclerosis (rare). Symptoms of nervous system disorders may include changes in vision, weakness in arms or legs, numbness or tingling in any part of the body.
  • Lymph node cancer (lymphoma) (rare). Symptoms of lymphoma may include swollen lymph nodes, weight loss, or fever.
  • Heart failure (rare). Symptoms of heart failure may include shortness of breath or swelling of the feet.
  • Signs of immune system disorders called:
  • Lupus (rare). Symptoms may include joint pain or a rash on cheeks or arms that is sensitive to sunlight.
  • Sarcoidosis (rare). Symptoms may include a persistent cough, shortness of breath, chest pain, fever, swollen lymph nodes, weight loss, skin rashes and blurred vision.
  • Swelling of small blood vessels (vasculitis) (rare). Symptoms may include fever, headache, weight loss, night sweats, rash and nerve problems such as numbness and tingling.
  • Skin cancer (uncommon). Symptoms of skin cancer may include changes in the appearance of the skin or skin growths.
  • Blood disorders (common). Symptoms of blood disorders may include a fever that does not go away, a strong tendency to bruise or bleed, or looking very pale.
  • Blood cancer (leukaemia) (rare). Symptoms of leukaemia may include fever, feeling tired, frequent infections, bruising and night sweats.

Tell your doctor immediately if you notice any of the symptoms listed above.

The following additional side effects have been observed with Simponi:

Very common side effects (may affect more than 1 in 10 people):

  • Infections of the upper respiratory tract, sore throat or hoarseness, common cold

Common side effects (may affect up to 1 in 10 people):

  • Abnormal liver function tests (increased liver enzymes), found during blood tests performed by your doctor
  • Dizziness
  • Headache
  • Numbness or tingling sensation
  • Superficial fungal infections
  • Abscess
  • Bacterial infections (such as cellulitis)
  • Reduction in red blood cells
  • Reduction in white blood cells
  • Positive blood test for lupus
  • Allergic reactions
  • Indigestion
  • Stomach pain
  • Feeling unwell (nausea)
  • Influenza
  • Bronchitis
  • Sinus infection
  • Facial herpes
  • High blood pressure
  • Fever
  • Asthma, shortness of breath, wheezing
  • Stomach and intestinal disorders including inflammation of the lining of the stomach and colon, which may cause fever
  • Pain and ulcers in the mouth
  • Injection site reactions (including redness, hardening, pain, bruising, itching, tingling and irritation)
  • Hair loss
  • Skin rash and itching
  • Difficulty sleeping
  • Depression
  • Feeling weak
  • Bone fractures
  • Chest pain

Uncommon side effects (may affect up to 1 in 100 people):

  • Kidney infection
  • Cancer, including skin cancer and non-cancerous growths or small masses, including moles
  • Skin blisters
  • Severe infection throughout the body (sepsis), sometimes including low blood pressure (septic shock)
  • Psoriasis (including on palms of hands and/or soles of feet and/or in the form of skin blisters)
  • Reduction in platelets
  • Combined reduction in platelets, red blood cells and white blood cells
  • Thyroid disorders
  • Increased blood sugar levels
  • Increased blood cholesterol levels
  • Balance disorders
  • Vision disorders
  • Inflamed eye (conjunctivitis)
  • Eye allergy
  • Sensation of irregular heartbeat
  • Narrowing of blood vessels in the heart
  • Blood clots
  • Flushing
  • Constipation
  • Chronic lung inflammation
  • Acid reflux
  • Gallstones
  • Liver disorders
  • Breast disorders
  • Menstrual disorders

Rare side effects (may affect up to 1 in 1,000 people):

  • Inability of the bone marrow to produce blood cells
  • Severe reduction in the number of white blood cells
  • Infection of joints or surrounding tissues
  • Poor wound healing
  • Inflammation of blood vessels in internal organs
  • Leukaemia
  • Melanoma (a type of skin tumour)
  • Merkel cell carcinoma (a type of skin tumour)
  • Lichenoid reactions (itchy purple-red rash and/or white-grey thread-like lines on mucous membranes)
  • Peeling skin
  • Immunological disorders affecting the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
  • Pain and discolouration in fingers or toes
  • Taste disturbances
  • Bladder disorders
  • Kidney disorders
  • Inflammation of blood vessels in the skin causing a rash

Side effects with unknown frequency:

  • A rare blood tumour affecting mainly young people (hepatosplenic T-cell lymphoma)
  • Kaposi’s sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi’s sarcoma most commonly presents with purple skin lesions
  • Worsening of a condition called dermatomyositis (which presents as a rash associated with muscle weakness)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Simponi

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date stated on the label and the carton after "Exp". The expiry date refers to the last day of that month.
  • Store in a refrigerator (2 °C–8 °C). Do not freeze.
  • Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
  • This medicine can also be stored outside the refrigerator at temperatures up to a maximum of 25 °C for a single period of up to 30 days, but not beyond the original expiry date printed on the carton. Write the new expiry date on the carton indicating day/month/year (no more than 30 days after the medicine has been removed from the refrigerator). Do not re-refrigerate this medicine once it has reached room temperature. Dispose of this medicine if not used by the new expiry date or by the printed expiry date on the carton, whichever comes first.
  • Do not use this medicine if you notice that the liquid is not clear to pale yellow, appears cloudy, or contains foreign particles.
  • Do not dispose of any medicine via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Simponi contains
The active substance is golimumab. One pre-filled syringe of 0.5 mL contains 50 mg of golimumab.
The other components are sorbitol (E420), histidine, monohydrate histidine hydrochloride, polysorbate 80 (E433), and water for injectable preparations. For further information on sorbitol (E420) and polysorbate 80 (E433), see section 2.

Description of the appearance of Simponi and contents of the pack
Simponi is supplied as an injectable solution in a single-use pre-filled syringe. Simponi is available in packs containing 1 pre-filled syringe and multipacks containing 3 (3 packs of 1) pre-filled syringes. Not all pack sizes may be marketed.

The solution is from clear to slightly opalescent (pearly appearance), from colourless to pale yellow, and may contain small translucent or white protein particles.

Do not use Simponi if the solution has changed colour, is cloudy, or contains visible foreign particles.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB "JOHNSON & JOHNSON"
Tel/Tél: 0800 93 377 Tel: +370 5 278 68 88
[email protected] [email protected]

България Luxembourg/Luxemburg
"Джонсън & Джонсън България" ЕООД Janssen-Cilag NV
Тел.: +359 2 489 94 00 Tél/Tel: 800 29 504 [email protected]
[email protected]

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD
Tlf.: +45 4594 8282 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: 0800 242 42 42
[email protected] [email protected]

Eesti Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]

Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε. Tel: +43 1 610 300
Tηλ: +30 210 80 90 000

España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.: +48 22 237 60 00
[email protected]

France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected] [email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor ehf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]

Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Τηλ: +357 22 207 700 Tfn: +46 8 626 50 00
[email protected]

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561
[email protected]

More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

INSTRUCTIONS FOR USE

If you wish to self-inject Simponi, you must be trained by a healthcare professional on how to
prepare an injection and administer it yourself. If you have not been trained, please inform your doctor,
nurse, or pharmacist to schedule a training session.
These instructions include:

  1. Preparation for using the prefilled syringe
  2. Choosing and preparing the injection site
  3. Administering the medicine by injection
  4. After the injection

The following figure (see Figure 1) shows what the prefilled syringe looks like.

Technical schematic of a syringe with descriptive labels for plunger, barrel, needle, protective cap, activation clip, and viewing window

Figure 1

1. Preparation for using the prefilled syringe

Hold the prefilled syringe by the barrel of the syringe

  • Do not hold it by the plunger rod, the plunger, the needle guard wings, or the needle cap.
  • Never pull back the plunger.
  • Never shake the prefilled syringe.
  • Do not remove the needle cap from the prefilled syringe until instructed to do so.
  • Do not touch the needle safety activation clips (indicated by asterisks * in Figure 1) to prevent the needle safety guard from prematurely covering the needle.

Check the number of prefilled syringes
Check the prefilled syringes to ensure that

  • the number of prefilled syringes and dosages are correct
    or
    If your dose is 50 mg, you will use one 50 mg prefilled syringe
    or
    If your dose is 100 mg, you will use two 50 mg prefilled syringes and will need to administer two injections. Choose two different injection sites for these injections (e.g., one injection in the right thigh and the other in the left thigh) and proceed with the injections one after the other.
    or
    If your dose is 200 mg, you will use four 50 mg prefilled syringes and will need to administer four injections. Choose different injection sites for these injections and proceed with the injections one after the other.

Check the expiration date (see Figure 2)

  • Check the expiration date printed or written on the carton.
  • Check the expiration date (indicated by “Exp.”) on the label by looking through the inspection window located in the barrel of the prefilled syringe.
  • If you cannot see the expiration date through the inspection window, hold the prefilled syringe by the barrel and rotate the needle cap until the expiration date aligns with the inspection window.

Do not use the prefilled syringe if the expiration date has passed. The printed expiration date refers to the last day of the month. Contact your doctor or pharmacist for assistance.

Two hands rotating a syringe with curved arrows indicating rotational movement for drug preparation

Figure 2
Wait 30 minutes to allow the prefilled syringe to reach room temperature

  • To ensure proper injection, leave the prefilled syringe at room temperature outside the carton for 30 minutes, out of the reach of children. Do not warm the prefilled syringe in any other way (for example, do not warm it in a microwave or in hot water). Do not remove the needle cap from the prefilled syringe while allowing it to reach room temperature.

Prepare the remaining supplies
While waiting, prepare the remaining supplies, including an alcohol swab, a cotton ball or gauze, and a sharps disposal container.
Check the liquid in the prefilled syringe

  • Hold the prefilled syringe by the barrel with the covered needle pointing downward.
  • Observe the liquid through the inspection window of the prefilled syringe and make sure it is clear to slightly opalescent (pearl-like sheen) and colorless to pale yellow. The solution may be used if it contains a few small translucent or white protein particles.
  • If you cannot see the liquid through the inspection window, hold the prefilled syringe by the barrel and rotate the needle cap until the liquid aligns with the inspection window (see Figure 2). Do not use the prefilled syringe if the solution is not the correct color, if it is cloudy, or if it contains larger particles. In this case, inform your doctor or pharmacist.

2. Selection and preparation of the injection site (see Figure 3)

  • The medicine is usually injected in the middle of the front of the thigh.
  • You may also use the lower abdominal area (abdomen) below the navel, except for the area within approximately 5 cm directly below the navel.
  • Do not inject in areas where the skin is tender, bruised, red, scaly, hard, or has scars or stretch marks.
  • If multiple injections are required for a single dose, the injections should be administered at different body sites.
Schematic drawing of a male torso with a gray area on

Figure 3
Injection site selection for the person assisting the patient (see Figure 4)

  • If the injection is to be administered by the person assisting the patient, the outer area of the upper arm may also be used.
  • All the sites mentioned above may be used regardless of body type or size.
Schematic drawing of a male torso with a rectangular gray area applied on the upper part of the right arm

Figure 4
Preparation of the injection site

  • Wash your hands thoroughly with soap and warm water.
  • Clean the injection site with an alcohol swab.
  • Allow the skin to dry before injecting. Do not blow on or fan the cleaned area. Do not touch this area before administering the injection.

3. Injection of the medicine

The needle protective cap should only be removed when you are ready to inject the medicine.
The medicine must be injected within 5 minutes after removing the needle protective cap.
Do not touch the plunger when removing the needle protective cap.
Remove the needle protective cap (see Figure 5)

  • When ready for injection, hold the pre-filled syringe body with one hand.
  • Pull the needle protective cap straight off and dispose of it after injection. Do not touch the plunger during this step.
  • You may notice an air bubble in the pre-filled syringe or a drop of liquid at the tip of the needle. This is normal and should not be removed.
  • Inject the dose immediately after removing the needle protective cap.

Do not touch the needle and avoid contact with any surface.
Do not use the pre-filled syringe if it has been dropped without the needle protective cap. In this case,
contact your doctor or pharmacist.

Technical drawing showing a hand holding a syringe and

Figure 5
Position the pre-filled syringe for injection

  • Hold the body of the pre-filled syringe between your index and middle fingers with one hand, place your thumb on the plunger head, and use your other hand to gently pinch the previously cleaned skin area. Hold the syringe firmly. Never pull back on the plunger.

Injecting the medicine

  • Angle the needle at approximately 45 degrees to the pinched skin. With one quick, smooth motion, insert the needle through the skin until it stops (see Figure 6).
Two drawings show the

Figure 6

  • Inject the entire dose by pressing the plunger until its head is completely within the needle safety guard wings (see Figure 7).
Two hands holding and rotating the upper part of a medical injection pen with the expiration date visible on the device body

Figure 7

  • When the plunger stops, continue applying pressure on the plunger head, withdraw the needle, and release the skin (see Figure 8).
A hand holds an injection pen to bring it closer to

Figure 8

  • Slowly remove your thumb from the plunger head to allow the empty pre-filled syringe to move upward until the needle is fully covered by the integrated safety shield, as shown in Figure 9:
Two hands holding and manipulating a cylindrical medical device with internal spring mechanism and transparent components for

Figure 9

4. After the injection

Use a cotton ball or gauze

  • There may be a small amount of blood or liquid at the injection site. This is normal.
  • You may press a cotton ball or gauze pad against the injection site for 10 seconds.
  • You may cover the injection site with a small adhesive bandage if needed. Do not rub the skin.

Dispose of the prefilled syringe (see Figure 10)

  • Immediately place the prefilled syringe in a sharps container. Make sure to dispose of the container according to the instructions provided by your doctor or nurse. Do not attempt to recap the needle. Never reuse the prefilled syringe—for your health and safety and for the safety of others.

If you think something went wrong with the injection, or if you are unsure, talk to your doctor or pharmacist.

A hand holds a syringe above a biohazard waste container with the biohazard symbol and the word BIOHAZARD

Figure 10

Package leaflet: Information for the user

Simponi 100 mg solution for injection in pre-filled pen

golimumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, because it could be harmful.
  • If any adverse reaction occurs, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Your doctor will provide you with a Patient Information Card containing important safety information that you should be aware of before and during treatment with Simponi.
Contents of this leaflet

  1. What Simponi is and what it is used for
  2. What you need to know before using Simponi
  3. How to use Simponi
  4. Possible side effects
  5. How to store Simponi
  6. Contents of the pack and other information

1. What Simponi is and what it is used for

Simponi contains an active substance called golimumab.
Simponi belongs to a group of medicines known as "TNF blockers". It is used in adults
for the treatment of the following inflammatory diseases:

  • Rheumatoid arthritis
  • Psoriatic arthritis
  • Axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis
  • Ulcerative colitis

Simponi works by blocking the action of a protein called "tumour necrosis factor alpha"
(TNF-α). This protein is involved in inflammatory processes in the body, and by blocking it,
inflammation in the body can be reduced.
Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints. If you have active rheumatoid arthritis,
you will initially be treated with other medicines. If you do not respond adequately to these
medicines, you will be treated with Simponi in combination with another medicine called
methotrexate to:

  • Reduce the signs and symptoms of the disease.
  • Slow down damage to bones and joints.
  • Improve physical function.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory skin disease. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you will be treated with Simponi to:

  • Reduce the signs and symptoms of the disease.
  • Slow down damage to bones and joints.
  • Improve physical function.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis
Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory diseases of the spine. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you will be treated with Simponi to:

  • Reduce the signs and symptoms of the disease.
  • Improve physical function.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the intestine. If you have ulcerative colitis, you will first be given other medicines. If you do not respond adequately to these medicines, Simponi will be given to treat your disease.

2. What you should know before using Simponi

Do not use Simponi

  • If you are allergic (hypersensitive) to golimumab or to any of the other ingredients of this medicine (listed in section 6).
  • If you have tuberculosis (TB) or any other serious infection.
  • If you have moderate or severe heart failure.

If you are unsure whether any of the conditions listed above may apply to you, speak with your doctor, pharmacist, or nurse before using Simponi.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Simponi.
Infections
Inform your doctor immediately if you have had or develop symptoms of infection during or after treatment with Simponi. Symptoms of infection include fever, cough, shortness of breath, flu-like symptoms, diarrhoea, wounds, dental problems, or a burning sensation when urinating.

  • You may be more likely to get infections while using Simponi.
  • Infections may progress more quickly and be more severe. In addition, past infections may recur.

Tuberculosis (TB)
Inform your doctor immediately if you notice symptoms of TB during treatment. Symptoms of TB include persistent cough, weight loss, feeling tired, fever, or night sweats.

  • Cases of TB have been reported in patients treated with Simponi, rarely even in patients who had been treated with TB medications. Your doctor will perform tests to assess whether you have TB. Your doctor will record these tests on the Patient Card.
  • It is very important that you inform your doctor if you have previously had TB or if you have been in close contact with someone who has or has had TB.
  • If your doctor believes you are at risk of TB, you may be treated with TB medications before starting Simponi.

Hepatitis B virus (HBV)

  • Inform your doctor if you are a carrier of or have or have had hepatitis B before being given Simponi.
  • Inform your doctor if you think you may be at risk of contracting hepatitis B.
  • Your doctor must perform tests to assess whether you have hepatitis B.
  • Treatment with TNF blockers such as Simponi can cause reactivation of the hepatitis B virus in patients who carry this virus, which in some cases may lead to death.

Invasive fungal infections
Inform your doctor immediately if you have lived in or travelled to an area where infections caused by specific types of fungi that can affect the lungs or other parts of the body are common (called histoplasmosis, coccidioidomycosis, or blastomycosis). Ask your doctor if you are unsure whether these fungal infections are common in the area where you have lived or travelled.
Tumours and lymphoma
Inform your doctor if you have or have ever had lymphoma (a type of blood cancer) or other types of cancer before being given Simponi.

  • If you use Simponi or other TNF blockers, your risk of developing lymphoma or another type of cancer may increase.
  • Patients with severe rheumatoid arthritis or other inflammatory diseases who have had the disease for a long time may have a higher than average risk of developing lymphoma.
  • Cases of cancer, including unusual types, sometimes fatal, have been reported in children and adolescents treated with TNF blocker medicines.
  • Rarely, a specific and serious type of lymphoma called hepatosplenic T-cell lymphoma has been observed in patients taking other TNF blockers. Most of these patients were adolescent or young adult males. This type of cancer has usually been fatal. Almost all of these patients had also received medications known as azathioprine or 6-mercaptopurine. Inform your doctor if you are taking azathioprine or 6-mercaptopurine with Simponi.
  • Patients with severe persistent asthma, chronic obstructive pulmonary disease (COPD), or habitual smokers may have an increased risk of cancer with treatment with Simponi. If you have severe persistent asthma, COPD, or are a habitual smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate.
  • Some patients treated with golimumab have developed certain types of skin cancer. If any changes in the appearance of your skin or skin growths appear during or after therapy, inform your doctor.

Heart failure
Inform your doctor immediately if you notice new symptoms of heart failure or worsening of existing symptoms. Symptoms of heart failure include shortness of breath or swelling of the feet.

  • Cases of new-onset or worsening congestive heart failure have been reported with TNF blockers, including Simponi. Some of these patients have died.
  • If you have mild heart failure and are treated with Simponi, your doctor will closely monitor you.

Nervous system disorders
Inform your doctor immediately if you have ever been diagnosed with or develop symptoms of a demyelinating disease such as multiple sclerosis. Symptoms may include changes in vision, weakness in arms and legs, numbness, or tingling in any part of the body. Your doctor will decide whether Simponi should be administered to you.
Surgery or dental procedures

  • Inform your doctor if you are scheduled for any surgery or dental procedures.
  • Inform the surgeon or dentist performing the procedure that you are being treated with Simponi, and show them your Patient Card.

Autoimmune diseases
Inform your doctor if you develop symptoms of a disease called lupus. Symptoms include persistent rash, fever, joint pain, and fatigue.

  • Rarely, people treated with TNF blockers have developed lupus.

Blood disorders
In some patients, the body may not produce enough blood cells that help the body fight infections or help stop bleeding. If you develop persistent fever of unknown origin, bruising easily, bleeding easily, or appear very pale, contact your doctor immediately. Your doctor may decide to stop treatment.
If you are unsure whether any of the conditions listed above may apply to you, speak with your doctor or pharmacist before using Simponi.
Vaccinations
Inform your doctor if you have recently been vaccinated or if you plan to be vaccinated.

  • You must not receive certain vaccines (live) while being treated with Simponi.
  • Some vaccinations may cause infections. If you received Simponi during pregnancy, the baby may have an increased risk of contracting such infection for approximately six months after the last dose received during pregnancy. It is important to inform the paediatrician and other healthcare providers about the use of Simponi so they can decide when the baby should receive any vaccine.

Therapeutic infectious agents
Talk to your doctor if you have recently taken or plan to take treatment with a therapeutic infectious agent (such as BCG instillation used to treat cancer).
Allergic reactions
Inform your doctor immediately if you develop symptoms of an allergic reaction after treatment with Simponi. Symptoms of an allergic reaction may include swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing, rash, hives, or swelling of hands, feet, and ankles.

  • Some of these reactions can be serious or, rarely, life-threatening.
  • Some of these reactions have occurred after the first dose of Simponi.

Children and adolescents
Simponi 100 mg in a pre-filled pen is not recommended for the treatment of children and adolescents (under 18 years of age).
Other medicines and Simponi

  • Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including any other medicines used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
  • You must not take Simponi with medicines containing the active substance anakinra or abatacept. These medicines are used to treat rheumatic diseases.
  • Inform your doctor or pharmacist if you are taking any other medicine that affects the immune system.
  • You must not receive certain vaccines (live) while using Simponi.

If you are unsure whether any of the conditions listed above may apply to you, speak with your doctor or pharmacist before using Simponi.
Pregnancy and breastfeeding
Talk to your doctor before using Simponi if:

  • You are pregnant, planning to become pregnant, or become pregnant while using Simponi. Limited information is available on the effects of this medicine in pregnant women. If you need to be treated with Simponi, you should avoid pregnancy by using an adequate contraceptive method during treatment and for at least 6 months after the last injection of Simponi. Simponi should be used during pregnancy only if strictly necessary for you.
  • You must wait at least 6 months after your last Simponi treatment before breastfeeding. You must stop breastfeeding if you are to be given Simponi.
  • If you received Simponi during pregnancy, the baby may have an increased risk of contracting an infection. It is important to inform the paediatrician and other healthcare providers about the use of Simponi before the baby receives any vaccine (for more information, see the section on vaccinations). If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Simponi has a minor influence on the ability to drive and use tools or machines. However, dizziness may occur after using Simponi. In this case, do not drive or use tools or machinery.
Simponi contains latex, sorbitol, and polysorbate
Latex sensitivity
A part of the pre-filled pen, the cap covering the needle, contains latex. Since latex can cause severe allergic reactions, inform your doctor before using Simponi if you or the person assisting you is allergic to latex.
Sorbitol intolerance
This medicine contains 41 mg of sorbitol (E420) in each pre-filled pen.
Polysorbate 80
This medicine contains 0.15 mg of polysorbate 80 (E433) per pre-filled pen. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Simponi

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, you must consult your doctor or pharmacist.
How much Simponi is administered
Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis and
non-radiographic axial spondyloarthritis:

  • The recommended dose is 50 mg administered once a month, on the same day each month.
  • Consult your doctor before taking the fourth dose. Your doctor will decide whether you should continue treatment with Simponi.
    If you weigh more than 100 kg, the dose may be increased to 100 mg (the content of 1 pre-filled pen), administered once a month, always on the same day each month.

Ulcerative colitis

  • The table below shows how you will generally use this medicine.
Initial treatmentAn initial dose of 200 mg (the contents of 2 pre-filled pens) followed by 100 mg (the contents of 1 pre-filled pen) after 2 weeks.
Maintenance treatment
  • In patients weighing less than 80 kg, 50 mg (to administer this dose, the 50 mg pre-filled pen or pre-filled syringe must be used) 4 weeks after their last treatment, then every 4 weeks thereafter. Your doctor may decide to prescribe 100 mg (the contents of 1 pre-filled pen) based on the effect that Simponi has on you.
    -In patients weighing 80 kg or more, 100 mg (the contents of 1 pre-filled pen) 4 weeks after their last treatment, then every 4 weeks thereafter.

How Simponi is administered

  • Simponi is administered by injection under the skin (subcutaneously).
  • Initially, your doctor or nurse will inject Simponi for you. However, you and your doctor may decide that you can self-inject Simponi or that you can inject it for your child. In this case, you will be instructed on how to inject Simponi. Speak with your doctor if you have any questions about self-administering an injection. At the end of this leaflet, you will find detailed “Instructions for use”.

If you use more Simponi than you should
If you have used or have been given too much Simponi (by injecting too much in a single
administration, or using it too frequently), inform your doctor or pharmacist immediately.
Always take the outer packaging and this leaflet with you, even if they are empty.
If you forget to use Simponi
If you forget to use Simponi on the scheduled day, inject the missed dose as soon as you remember.
Do not use a double dose to make up for the forgotten dose.
When to inject the next dose:

  • If the delay is less than 2 weeks, inject the missed dose as soon as you remember and continue following the original schedule.
  • If the delay is more than 2 weeks, inject the missed dose as soon as you remember and inform your doctor or pharmacist, asking when you should take the next dose.

If you have any doubts about what to do, consult your doctor or pharmacist.
If you stop treatment with Simponi
If you are considering stopping treatment with Simponi, consult your doctor or pharmacist first.
If you have any questions about using this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. Some patients may experience serious side effects that may require medical treatment. The risk of certain side effects is higher with the 100 mg dose compared to the 50 mg dose. Side effects may also occur several months after the last injection.

Inform your doctor immediately if you notice any of the following serious side effects of Simponi, including:

  • Allergic reactions, which may be severe, or rarely, potentially life-threatening (rare). Symptoms of an allergic reaction may include swelling of the face, lips, mouth or throat, which may cause difficulty swallowing or breathing, rash, hives, swelling of hands, feet or ankles. Some of these reactions occurred after the first administration of Simponi.
  • Serious infections (including TB, bacterial infections such as severe blood infections and pneumonia, serious fungal infections and other opportunistic infections) (common). Symptoms of infection may include fever, fatigue, cough (persistent), shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, dental problems and a burning sensation when urinating.
  • Reactivation of hepatitis B virus if you are a carrier or have previously had hepatitis B (rare). Symptoms may include yellowing of the skin and eyes, dark brown urine, pain in the right side of the abdomen, fever, feeling unwell, malaise and a strong feeling of fatigue.
  • Nervous system disorders such as multiple sclerosis (rare). Symptoms of nervous system disorders may include changes in vision, weakness in arms or legs, numbness or tingling in any part of the body.
  • Lymph node cancer (lymphoma) (rare). Symptoms of lymphoma may include swollen lymph nodes, weight loss, or fever.
  • Heart failure (rare). Symptoms of heart failure may include shortness of breath or swelling of the feet.
  • Signs of immune system disorders called:
  • Lupus (rare). Symptoms may include joint pain or a rash on cheeks or arms that is sensitive to sunlight.
  • Sarcoidosis (rare). Symptoms may include a persistent cough, shortness of breath, chest pain, fever, swollen lymph nodes, weight loss, skin rashes and blurred vision.
  • Swelling of small blood vessels (vasculitis) (rare). Symptoms may include fever, headache, weight loss, night sweats, rash and nerve problems such as numbness and tingling.
  • Skin cancer (uncommon). Symptoms of skin cancer may include changes in the appearance of the skin or skin growths.
  • Blood disorders (common). Symptoms of blood disorders may include persistent fever, a strong tendency to bruise or bleed, or a very pale appearance.
  • Blood cancer (leukaemia) (rare). Symptoms of leukaemia may include fever, feeling tired, frequent infections, bruising and night sweats.

Inform your doctor immediately if you notice any of the symptoms listed above.

The following additional side effects have been observed with Simponi:

Very common side effects (may affect more than 1 in 10 people):

  • Upper respiratory tract infections, sore throat or hoarseness, cold

Common side effects (may affect up to 1 in 10 people):

  • Abnormal liver function tests (increased liver enzymes), detected during blood tests performed by your doctor
  • Dizziness
  • Headache
  • Numbness or tingling sensation
  • Superficial fungal infections
  • Abscess
  • Bacterial infections (such as cellulitis)
  • Reduction in red blood cells
  • Reduction in white blood cells
  • Positive blood test for lupus
  • Allergic reactions
  • Indigestion
  • Stomach pain
  • Feeling unwell (nausea)
  • Influenza
  • Bronchitis
  • Sinus infection
  • Oral herpes
  • High blood pressure
  • Fever
  • Asthma, shortness of breath, wheezing
  • Stomach and intestinal disorders, including inflammation of the inner lining of the stomach and colon, which may cause fever
  • Pain and ulcers in the mouth
  • Injection site reactions (including redness, hardening, pain, bruising, itching, tingling and irritation)
  • Hair loss
  • Skin rash and itching
  • Difficulty sleeping
  • Depression
  • Feeling weak
  • Bone fractures
  • Chest pain

Uncommon side effects (may affect up to 1 in 100 people):

  • Kidney infection
  • Cancer, including skin cancer and non-cancerous swellings or small masses, including moles
  • Skin blisters
  • Severe infection throughout the body (sepsis), sometimes including low blood pressure (septic shock)
  • Psoriasis (including on palms of hands and/or soles of feet and/or in the form of skin blisters)
  • Reduction in platelets
  • Combined reduction in platelets, red blood cells and white blood cells
  • Thyroid disorders
  • Increased blood sugar levels
  • Increased cholesterol levels in the blood
  • Balance disorders
  • Vision disorders
  • Inflamed eye (conjunctivitis)
  • Eye allergy
  • Sensation of irregular heartbeat
  • Narrowing of blood vessels in the heart
  • Blood clots
  • Flushing
  • Constipation
  • Chronic lung inflammation
  • Acid reflux
  • Gallstones
  • Liver disorders
  • Breast disorders
  • Menstrual disorders

Rare side effects (may affect up to 1 in 1,000 people):

  • Inability of the bone marrow to produce blood cells
  • Severe reduction in the number of white blood cells
  • Infection of joints or surrounding tissues
  • Poor wound healing
  • Inflammation of blood vessels in internal organs
  • Leukaemia
  • Melanoma (a type of skin tumour)
  • Merkel cell carcinoma (a type of skin tumour)
  • Lichenoid reactions (itchy purple-red rash and/or white-grey thread-like lines on mucous membranes)
  • Skin peeling
  • Immunological disorders that may affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
  • Pain and discoloration in fingers of the hands or feet
  • Taste disturbances
  • Bladder disorders
  • Kidney disorders
  • Inflammation of blood vessels in the skin causing a skin rash

Side effects with unknown frequency:

  • A rare blood tumour affecting mainly young people (hepatosplenic T-cell lymphoma)
  • Kaposi’s sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi’s sarcoma most commonly presents with purple skin lesions
  • Worsening of a condition called dermatomyositis (which manifests as a rash associated with muscle weakness)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Simponi

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date stated on the label and on the carton after “Exp”. The expiry date refers to the last day of that month.
  • Store in a refrigerator (2 °C–8 °C). Do not freeze.
  • Keep the pre-filled pen in the outer packaging to protect the medicine from light.
  • This medicine can also be stored outside the refrigerator at temperatures up to a maximum of 25 °C for a single period of up to 30 days, but not beyond the original expiry date printed on the carton. Write the new expiry date on the carton indicating day/month/year (no more than 30 days after the medicine has been removed from the refrigerator). Do not re-refrigerate this medicine once it has reached room temperature. Dispose of this medicine if not used by the new expiry date or by the printed expiry date on the carton, whichever comes first.
  • Do not use this medicine if you notice that the liquid is not clear to slightly yellow, appears cloudy, or contains foreign particles.
  • Do not dispose of any medicine via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Simponi contains
The active substance is golimumab. A single-use pre-filled pen containing 1 mL solution contains 100 mg of golimumab.
The other components are sorbitol (E420), histidine, monohydrochloride monohydrate histidine, polysorbate 80 (E433), and water for injections. For further information on sorbitol (E420) and polysorbate 80 (E433), see section 2.

Description of the appearance of Simponi and contents of the pack
Simponi is supplied as an injectable solution in a single-use pre-filled pen. Simponi is available in packs containing 1 pre-filled pen and multipacks containing 3 (3 packs of 1) pre-filled pens. Not all pack sizes may be marketed.
The solution is from clear to slightly opalescent (pearl-like sheen), from colourless to pale yellow, and may contain a few small translucent or white protein particles.
Do not use Simponi if the solution has changed colour, is cloudy, or contains visible foreign particles.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB "JOHNSON & JOHNSON"
Tel/Tél: 0800 93 377 Tel: +370 5 278 68 88
[email protected] [email protected]

България Luxembourg/Luxemburg
„Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Тел.: +359 2 489 94 00 Tél/Tel: 800 29 504
[email protected] [email protected]

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD
Tlf.: +45 4594 8282 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: 0800 242 42 42
[email protected] [email protected]

Eesti Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]

Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε. Tel: +43 1 610 300
Tηλ: +30 210 80 90 000

España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.: +48 22 237 60 00
[email protected]

France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected] [email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor ehf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]

Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Τηλ: +357 22 207 700 Tfn: +46 8 626 50 00
[email protected]

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561
[email protected]

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

INSTRUCTIONS FOR USE

If you wish to self-inject Simponi, you must be trained by a healthcare professional on how to
prepare an injection and administer it yourself. If you have not been trained, please inform your doctor,
nurse, or pharmacist to schedule a training session.
These instructions include:

  1. Preparation for using the pre-filled pen
  2. Selection and preparation of the injection site
  3. Administration of the medicine
  4. After the injection

The following figure (see Figure 1) shows what the pre-filled pen “SmartJect” looks like.

Diagram of a medical device with labels indicating the green safety sleeve, viewing window, and raised part of the button Medical diagram with labels indicating cap, safety seal, transparent cover, and expiration date

Figure 1

1. Preparation for using the prefilled pen

  • Never shake the prefilled pen.
  • Do not remove the cap from the prefilled pen until immediately before injecting.
  • If removed, do not reinsert the cap into the prefilled pen to avoid bending the needle.

Check the number of prefilled pens
Check the prefilled pens to ensure that:

  • the number of prefilled pens and the dosage are correct.
    • If your dose is 100 mg, you will use one 100 mg prefilled pen.
    • If your dose is 200 mg, you will use two 100 mg prefilled pens and must administer two injections. Choose different injection sites for these injections and perform the injections one after the other.

Check the expiration date

  • Check the expiration date printed or written on the box.
  • Check the expiration date (indicated by “Exp.”) on the prefilled pen.
  • Do not use the prefilled pen if the expiration date has passed. The printed expiration date refers to the last day of the month. Contact your doctor or pharmacist for assistance.

Check the security seal

  • Check the security seal around the cap of the prefilled pen.
  • Do not use the prefilled pen if the seal is broken. Contact your doctor or pharmacist.

Wait 30 minutes to allow the prefilled pen to reach room temperature

  • To ensure proper injection, leave the prefilled pen at room temperature outside the box for 30 minutes, out of the reach of children.
  • Do not warm the prefilled pen in any other way (for example, do not warm it in a microwave or in hot water).
  • Do not remove the cap from the prefilled pen while allowing it to reach room temperature.

Prepare the remaining supplies

  • While waiting, prepare the remaining supplies, including an alcohol swab, a cotton ball or gauze, and a sharps container.

Check the liquid in the prefilled pen

  • Look through the inspection window and make sure that the liquid in the prefilled pen is from clear to slightly opalescent (pearl-like luster) and colorless to pale yellow. The solution may be used if it contains a few small translucent or white protein particles.
  • You may also notice an air bubble, but this is normal.
  • Do not use the prefilled pen if the liquid is not the correct color, if it is cloudy, or if it contains larger particles. In this case, inform your doctor or pharmacist.

2. Selection and preparation of the injection site (see Figure 2)

  • You may inject the medicine in the central front part of the thighs.
  • You may use the abdomen below the navel, except for an area of about 5 cm directly below the navel.
  • Do not inject in areas where the skin is tender, bruised, red, scaly, hard, or has scars or stretch marks.
  • If multiple injections are required for a single administration, the injections must be given at different injection sites.
Schematic drawing of torso and legs of a person with gray areas indicating zones of

Figure 2

Danger symbol with a white exclamation mark inside

DO NOT inject in the arm to avoid malfunction of the pre-filled pen and/or accidental injury.
Hand washing and cleaning of the injection site

  • Wash your hands thoroughly with soap and warm water.
  • Rub the injection site with an alcohol swab.
  • Allow the skin to dry completely before injecting. Do not blow or fan the cleaned area.
  • Do not touch this area before administering the injection.

3. Medication Injection

  • Remove the cap only when you are ready to inject the medication.
  • The medication must be injected within 5 minutes after removing the cap.

Remove the cap (Figure 3)

  • When ready to inject, gently twist the cap to break the safety seal.
  • Pull the cap straight off and dispose of it after injection.
  • Do not reinsert the cap, as it may damage the needle inside the pre-filled pen.
  • Do not use the pre-filled pen if it has been dropped without the cap. In this case, contact your doctor or pharmacist.
Two hands rotating a medical device clockwise and two hands separating it by moving laterally to the left

Figure 3
Press the pre-filled pen against the skin (see Figures 4 and 5) without pinching the skin

A hand holds a medical device vertically at 90 degrees with an enlargement showing the green safety sleeve

Figure 4

  • Hold the pre-filled pen comfortably in one hand above the blue button.
  • Ensure that the green safety shield is stable and pressed as flat as possible against the skin. If the pre-filled pen is not stable during injection, the needle may bend.
  • DO NOT pinch the skin to avoid accidental needle injuries.
  • DO NOT touch or press the blue button while positioning the pen on the skin.
A hand holds a medical device vertically at 90 degrees relative to the surface with an enlargement of the contact tip

Figure 5

  • Press the open end of the pre-filled pen perpendicularly (at a 90-degree angle) against the skin. Apply enough pressure to make the green safety shield slide upward into the transparent cover. Only the wider part of the green safety shield remains outside the transparent cover.
  • DO NOT press the blue button until the safety shield has fully slid into the transparent cover. If the blue button is pressed before the safety shield has slid in, the pen may not function properly.
  • Inject without pinching the skin.

Press the button to inject (see Figures 6 and 7)

Illustration of a medical device with a circle highlighting the button to press and the text 'Press button here' Two hands holding a cylindrical medical device with a finger pressing a central button and the text '1st CLICK' next to the base

Figure 6 Figure 7

  • Continue pressing the pre-filled pen firmly against the skin. Use your other hand to press the raised portion of the blue button to start the injection. Do not press the button if the pre-filled pen is not pressed firmly against the skin and the safety shield has not fully slid into the transparent cover.
  • Once pressed, the button will remain depressed, so you do not need to keep applying pressure.
  • If the button feels difficult to press, do not press harder. Release the button, lift the pre-filled pen, and start again. Make sure no pressure is applied to the button until the green safety shield is fully pressed against the skin, then press the raised portion of the button.
  • You will hear a loud “click” – do not be alarmed. The first “click” indicates that the needle has been inserted and the injection has started. At this point, you may or may not feel the needle insertion.

Do not lift the pre-filled pen from the skin. If you lift the pre-filled pen from the skin,
you may not have injected the full dose of medication.
Continue pressing until you hear the second “click” (see Figure 8). This usually takes 3 to
6 seconds, but it may take up to 15 seconds to hear the second “click”.

Black and white drawing showing two hands holding a medical device with a finger pressing a button and the text '2nd CLICK'

Figure 8

  • Keep holding the pre-filled pen against the skin until you hear a second “click” (indicating that the injection is complete and the needle has retracted into the pre-filled pen).
  • Lift the pre-filled pen away from the injection site.
  • Note: If you do not hear the second “click”, wait 15 seconds from the moment you first pressed the button, then remove the autoinjector from the injection site.

4. After the injection

Use a cotton ball or gauze

  • A small amount of blood or fluid at the injection site may occur. This is normal.
  • You may press a cotton ball or gauze against the injection site for 10 seconds.
  • If needed, you may cover the injection site with a small adhesive bandage.
  • Do not rub the skin.

Check the window – a yellow indicator confirms successful administration (see
Figure 9)

  • The yellow indicator is connected to the plunger of the pre-filled pen. If the yellow indicator does not appear in the window, the plunger has not advanced properly and the injection has not been administered.
  • The yellow indicator will fill approximately half of the viewing window. This is normal.
  • Consult your doctor or pharmacist if the yellow indicator is not visible in the window or if you suspect you may not have received a complete dose. Do not administer a second dose without first speaking to your doctor.
Technical drawing of a medical device with a black arrow pointing to an internal window labeled 'Yellow indicator'

Figure 9
Dispose of the pre-filled pen (see Figure 10)

  • Immediately place the pen into a sharps disposal container. When the container is full, make sure to dispose of it according to the instructions provided by your doctor or nurse.

If you think something did not work properly during the injection or if you are unsure,
talk to your doctor or pharmacist.

A hand holds a medical device above a biohazard waste container with the biohazard symbol and the word BIOHAZARD

Figure 10

Package leaflet: Information for the user

Simponi 100 mg solution for injection in pre-filled syringe

golimumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, consult your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Never give it to others, even if their symptoms are the same as yours, because it could be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Your doctor will provide you with a Patient Information Card containing important safety information that you should be aware of before and during treatment with Simponi.
Contents of this leaflet

  1. What Simponi is and what it is used for
  2. What you need to know before using Simponi
  3. How to use Simponi
  4. Possible side effects
  5. How to store Simponi
  6. Contents of the pack and other information

1. What Simponi is and what it is used for

Simponi contains an active substance called golimumab.
Simponi belongs to a group of medicines known as "TNF blockers". It is used in adults
for the treatment of the following inflammatory diseases:

  • Rheumatoid arthritis
  • Psoriatic arthritis
  • Axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis
  • Ulcerative colitis

Simponi is used in children aged 2 years and older and weighing more than 15 kg for the treatment of pediatric ulcerative colitis.
Simponi works by blocking the action of a protein called "tumor necrosis factor alpha" (TNF-α). This protein is involved in inflammatory processes in the body, and by blocking it, inflammation in the body can be reduced.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints. If you have active rheumatoid arthritis, you will initially be treated with other medicines. If you do not respond adequately to these medicines, you will be treated with Simponi in combination with another medicine called methotrexate to:

  • Reduce the signs and symptoms of the disease.
  • Slow down damage to bones and joints.
  • Improve physical function.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory skin disease. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you will be treated with Simponi to:

  • Reduce the signs and symptoms of the disease.
  • Slow down damage to bones and joints.
  • Improve physical function.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis
Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory diseases of the spine. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you will be treated with Simponi to:

  • Reduce the signs and symptoms of the disease.
  • Improve physical function.

Ulcerative colitis (in adults and pediatric patients)
Ulcerative colitis is an inflammatory disease of the intestine. If you have ulcerative colitis, you will first be given other medicines. If you do not respond adequately to these medicines, Simponi will be administered to treat your disease.

2. What you need to know before using Simponi

Do not use Simponi

  • If you are allergic (hypersensitive) to golimumab or to any of the other ingredients of this medicine (listed in section 6).
  • If you have tuberculosis (TB) or any other serious infection.
  • If you have moderate or severe heart failure.

If you are unsure whether any of the conditions listed above may apply to you, speak with your doctor, pharmacist, or nurse before using Simponi.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Simponi.
Infections
Inform your doctor immediately if you have previously had or develop symptoms of infection during or after treatment with Simponi. Symptoms of infection include fever, cough, shortness of breath, flu-like symptoms, diarrhoea, wounds, dental problems, or a burning sensation when urinating.

  • You may be more likely to get infections while using Simponi.
  • Infections may progress more quickly and be more severe. In addition, past infections may recur.

Tuberculosis (TB)
Inform your doctor immediately if you notice symptoms of TB during treatment. Symptoms of TB include a persistent cough, weight loss, feeling tired, fever, or night sweats.

  • Cases of TB have been reported in patients treated with Simponi, rarely even in patients who have been treated with medicines for TB. Your doctor will perform tests to assess whether you have TB. Your doctor will record these tests on the Patient Card.
  • It is very important that you inform your doctor if you have previously had TB or if you have been in close contact with someone who has or has had TB.
  • If your doctor believes you are at risk of TB, you may be treated with TB medicines before Simponi is administered.

Hepatitis B virus (HBV)

  • Inform your doctor if you are a carrier or have or have had hepatitis B before Simponi is administered.
  • Inform your doctor if you think you may be at risk of contracting hepatitis B.
  • Your doctor must perform tests to assess whether you have hepatitis B.
  • Treatment with TNF blockers such as Simponi may cause reactivation of the hepatitis B virus in patients who are carriers of this virus, which in some cases may lead to death.

Invasive fungal infections
Inform your doctor immediately if you have lived in or travelled to an area where infections caused by specific types of fungi that can affect the lungs or other parts of the body (called histoplasmosis, coccidioidomycosis, or blastomycosis) are common. Ask your doctor if you are unsure whether these fungal infections are common in the area where you have lived or travelled.
Tumours and lymphoma
Inform your doctor if you have or have ever had lymphoma (a type of blood cancer) or other types of cancer before Simponi is administered.

  • If you use Simponi or other TNF blockers, your risk of developing lymphoma or another type of cancer may increase.
  • Patients with severe rheumatoid arthritis or other inflammatory diseases who have had the disease for a long time may have a higher than average risk of developing lymphoma.
  • Cases of cancer, including unusual types, sometimes fatal, have been reported in children and adolescents treated with TNF blocker medicines.
  • Rarely, a specific and serious type of lymphoma called hepatosplenic T-cell lymphoma has been observed in patients taking other TNF blockers. Most of these patients were adolescent or young adult males. This type of cancer has usually been fatal. Almost all of these patients had also received medicines known as azathioprine or 6-mercaptopurine. Inform your doctor if you are taking azathioprine or 6-mercaptopurine with Simponi.
  • Patients with severe persistent asthma, chronic obstructive pulmonary disease (COPD), or regular smokers may have an increased risk of cancer with treatment with Simponi. If you have severe persistent asthma, COPD, or are a regular smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate.
  • Some patients treated with golimumab have developed certain types of skin cancer. If any changes in the appearance of your skin or skin growths develop during or after therapy, inform your doctor.

Heart failure
Inform your doctor immediately if you notice new symptoms of heart failure or worsening of existing symptoms. Symptoms of heart failure include shortness of breath or swelling of the feet.

  • Cases of new-onset congestive heart failure or worsening of existing heart failure have been reported with TNF blockers, including Simponi. Some of these patients have died.
  • If you have mild heart failure and are treated with Simponi, your doctor will closely monitor you.

Nervous system disorders
Inform your doctor immediately if you have ever been diagnosed with or develop symptoms of a demyelinating disease such as multiple sclerosis. Symptoms may include changes in vision, weakness in arms or legs, numbness, or tingling anywhere in the body. Your doctor will decide whether Simponi should be administered.

Surgery or dental procedures

  • Inform your doctor if you are scheduled for any surgery or dental procedures.
  • Inform the surgeon or dentist performing the procedure that you are being treated with Simponi, and show them your Patient Card.

Autoimmune diseases
Inform your doctor if you develop symptoms of a disease called lupus. Symptoms include persistent skin rash, fever, joint pain, and fatigue.

  • Rarely, people treated with TNF blockers have developed lupus.

Blood disorders
In some patients, the body may not produce enough blood cells that help fight infections or help stop bleeding. If you develop persistent fever of unknown origin, bruise easily, bleed easily, or become very pale, call your doctor immediately. Your doctor may decide to stop treatment.
If you are unsure whether any of the conditions listed above may apply to you, speak with your doctor or pharmacist before using Simponi.
Vaccinations
Inform your doctor if you have recently been vaccinated or if you plan to be vaccinated.

  • You must not receive certain vaccines (live) while being treated with Simponi.
  • Some vaccinations may cause infections. If you received Simponi during pregnancy, the baby may have an increased risk of contracting such infections for approximately six months after the last dose received during pregnancy. It is important to inform the paediatrician and other healthcare providers about the use of Simponi so they can decide when the baby should receive any vaccine.

Therapeutic infectious agents
Talk to your doctor if you have recently taken or plan to take treatment with a therapeutic infectious agent (such as BCG instillation used to treat cancer).
Allergic reactions
Inform your doctor immediately if you develop symptoms of an allergic reaction after treatment with Simponi. Symptoms of an allergic reaction may include swelling of the face, lips, mouth, or throat that may cause difficulty swallowing or breathing, rash, hives, or swelling of hands, feet, and ankles.

  • Some of these reactions may be serious or, rarely, life-threatening.
  • Some of these reactions have occurred after the first dose of Simponi.

Children
Simponi is not recommended for the treatment of children under two years of age with paediatric ulcerative colitis, as it has not been studied in this population.
Other medicines and Simponi

  • Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including any other medicines used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
  • You must not take Simponi with medicines containing the active substance anakinra or abatacept. These medicines are used to treat rheumatic diseases.
  • Inform your doctor or pharmacist if you are taking any other medicine that affects the immune system.
  • You cannot be treated with certain vaccines (live) while using Simponi.

If you are unsure whether any of the conditions listed above may apply to you, speak with your doctor or pharmacist before using Simponi.
Pregnancy and breastfeeding
Talk to your doctor before using Simponi if:

  • You are pregnant, planning to become pregnant, or become pregnant while using Simponi. Limited information is available on the effects of this medicine in pregnant women. If you need to be treated with Simponi, you should avoid pregnancy by using an adequate method of contraception during treatment and for at least 6 months after the last injection of Simponi. Simponi should be used during pregnancy only if strictly necessary for you.
  • Breastfeeding should be delayed until at least 6 months after your last treatment with Simponi. You must stop breastfeeding if Simponi is to be administered to you.
  • If you received Simponi during pregnancy, the baby may have an increased risk of contracting an infection. It is important to inform the paediatrician and other healthcare providers about the use of Simponi before the baby receives any vaccine (for more information, see the section on vaccinations). If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Simponi has a minor influence on the ability to drive and use machines. After using Simponi, dizziness may occur. In this case, do not drive or use tools or machines.
Simponi contains latex, sorbitol, and polysorbate
Latex sensitivity
A part of the pre-filled syringe, the cap covering the needle, contains latex. Since latex can cause severe allergic reactions, inform your doctor before using Simponi if you or your caregiver are allergic to latex.
Sorbitol intolerance
This medicine contains 41 mg of sorbitol (E420) in each pre-filled syringe.
Polysorbate 80
This medicine contains 0.15 mg of polysorbate 80 (E433) per pre-filled syringe. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Simponi

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, you must consult your doctor or pharmacist.
How much Simponi is administered
Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis and
non-radiographic axial spondyloarthritis:

  • The recommended dose is 50 mg administered once a month, on the same day each month.
  • Consult your doctor before taking the fourth dose. Your doctor will decide whether you should continue treatment with Simponi. If you weigh more than 100 kg, the dose may be increased to 100 mg (the content of 1 pre-filled syringe), administered once a month, always on the same day each month.

Ulcerative colitis in adults

  • The table below shows how you will generally use this medicine.
Initial treatmentAn initial dose of 200 mg (the contents of 2 pre-filled syringes) followed by 100 mg (the contents of 1 pre-filled syringe) after 2 weeks.
Maintenance treatment
  • In patients weighing less than 80 kg, 50 mg (to administer this dose, use the pre-filled pen or the 50 mg pre-filled syringe) 4 weeks after their last treatment, then every 4 weeks thereafter. The physician may decide to prescribe 100 mg (the contents of 1 pre-filled syringe), based on the effect that Simponi has on the patient.
    -In patients weighing 80 kg or more, 100 mg (the contents of 1 pre-filled syringe) 4 weeks after their last treatment, then every 4 weeks thereafter.

Pediatric ulcerative colitis in children aged 2 years and older weighing at least 15 kg:

  • The following table shows how you will use this medicine.
Initial treatment
  • In patients weighing at least 15 kg to less than 40 kg, an initial dose of 100 mg (the contents of 1 pre-filled syringe) followed by 50 mg (the 50 mg pre-filled syringe must be used to administer this dose) 2 weeks later.-In patients weighing more than 40 kg, an initial dose of 200 mg (the contents of 2 pre-filled syringes) followed by 100 mg (the contents of 1 pre-filled syringe) 2 weeks later.
Maintenance treatment
  • In patients weighing at least 15 kg to less than 40 kg, 50 mg (the 50 mg pre-filled syringe must be used to administer this dose) 4 weeks after the last treatment, then every 4 weeks.-In patients weighing at least 40 kg to less than 80 kg, 100 mg (the contents of 1 pre-filled syringe) 4 weeks after the last treatment, then every 4 weeks.-In patients weighing 80 kg or more, 100 mg (the contents of 1 pre-filled syringe) 4 weeks after the last treatment, then every 4 weeks.

Your doctor will tell you the correct dose to use.
How Simponi is administered

  • Simponi is administered by injection under the skin (subcutaneously).
  • Initially, your doctor or nurse will inject Simponi for you. However, you and your doctor may decide that you can self-inject Simponi or administer it to a child. In this case, you will be trained on how to inject Simponi. Speak with your doctor if you have any questions about self-administering an injection. At the end of this leaflet, you will find detailed “Instructions for use”.

If you use more Simponi than you should
If you have used or have been given too much Simponi (by injecting too much in a single administration, or using it too frequently), contact your doctor or pharmacist immediately.
Always take the outer packaging and this leaflet with you, even if they are empty.

If you forget to use Simponi
If you forget to use Simponi on the scheduled day, inject the missed dose as soon as you remember.
Do not use a double dose to make up for the forgotten dose.
When to inject the next dose:

  • If the delay is less than 2 weeks, inject the missed dose as soon as you remember and continue following the original schedule.
  • If the delay is more than 2 weeks, inject the missed dose as soon as you remember and contact your doctor or pharmacist to ask when you should take the next dose.

If you have any doubts about what to do, consult your doctor or pharmacist.

If you stop using Simponi
If you are considering stopping treatment with Simponi, speak to your doctor or pharmacist first.
If you have any questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some patients may experience serious side effects that may require medical treatment. The risk of certain side effects is higher with the 100 mg dose compared to the 50 mg dose. Side effects may also occur several months after the last injection.

Immediately inform your doctor if you notice any of the following serious side effects of Simponi, including:

  • Allergic reactions, which may be severe or, rarely, potentially life-threatening (rare). Symptoms of an allergic reaction may include swelling of the face, lips, mouth or throat, which may cause difficulty swallowing or breathing, rash, hives, swelling of hands, feet or ankles. Some of these reactions occurred after the first dose of Simponi.
  • Serious infections (including TB, bacterial infections such as serious blood infections and pneumonia, serious fungal infections and other opportunistic infections) (common). Symptoms of infection may include fever, fatigue, cough (persistent), shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, sores, dental problems and a burning sensation when urinating.
  • Reactivation of hepatitis B virus if you are a carrier or have previously had hepatitis B (rare). Symptoms may include yellowing of the skin and eyes, dark brown urine, pain in the right side of the abdomen, fever, feeling unwell, malaise and severe tiredness.
  • Nervous system disorders such as multiple sclerosis (rare). Symptoms of nervous system disorders may include changes in vision, weakness in arms or legs, numbness or tingling in any part of the body.
  • Lymph node cancer (lymphoma) (rare). Symptoms of lymphoma may include swollen lymph nodes, weight loss, or fever.
  • Heart failure (rare). Symptoms of heart failure may include shortness of breath or swelling of the feet.
  • Signs of immune system disorders known as:
  • Lupus (rare). Symptoms may include joint pain or a rash on cheeks or arms that is sensitive to sunlight.
  • Sarcoidosis (rare). Symptoms may include persistent cough, shortness of breath, chest pain, fever, swollen lymph nodes, weight loss, skin rashes and blurred vision.
  • Swelling of small blood vessels (vasculitis) (rare). Symptoms may include fever, headache, weight loss, night sweats, rash and nerve problems such as numbness and tingling.
  • Skin cancer (uncommon). Symptoms of skin cancer may include changes in the appearance of the skin or skin growths.
  • Blood disorders (common). Symptoms of blood disorders may include persistent fever, tendency to bruise or bleed easily, or looking very pale.
  • Blood cancer (leukaemia) (rare). Symptoms of leukaemia may include fever, feeling tired, frequent infections, bruising and night sweats.

Immediately inform your doctor if you notice any of the symptoms listed above.

The following additional side effects have been observed with Simponi:

Very common side effects (may affect more than 1 in 10 people):

  • Upper respiratory tract infections, sore throat or hoarseness, cold

Common side effects (may affect up to 1 in 10 people):

  • Abnormal liver function tests (increased liver enzymes), detected during blood tests performed by your doctor
  • Dizziness
  • Headache
  • Numbness or tingling sensation
  • Superficial fungal infections
  • Abscess
  • Bacterial infections (such as cellulitis)
  • Reduction in red blood cells
  • Reduction in white blood cells
  • Positive blood test for lupus
  • Allergic reactions
  • Indigestion
  • Stomach pain
  • Feeling unwell (nausea)
  • Influenza
  • Bronchitis
  • Sinus infection
  • Facial herpes
  • High blood pressure
  • Fever
  • Asthma, shortness of breath, wheezing
  • Stomach and intestinal disorders including inflammation of the lining of the stomach and colon, which may cause fever
  • Pain and ulcers in the mouth
  • Injection site reactions (including redness, hardening, pain, bruising, itching, tingling and irritation)
  • Hair loss
  • Skin rash and itching
  • Difficulty sleeping
  • Depression
  • Feeling weak
  • Bone fractures
  • Chest pain

Uncommon side effects (may affect up to 1 in 100 people):

  • Kidney infection
  • Cancer, including skin cancer and non-cancerous swellings or small masses, including moles
  • Skin blisters
  • Severe infection throughout the body (sepsis), which sometimes includes low blood pressure (septic shock)
  • Psoriasis (including on palms of hands and/or soles of feet and/or in the form of skin blisters)
  • Reduction in platelets
  • Combined reduction in platelets, red blood cells and white blood cells
  • Thyroid disorders
  • Increased blood sugar levels
  • Increased blood cholesterol levels
  • Balance disorders
  • Vision disorders
  • Inflamed eye (conjunctivitis)
  • Eye allergy
  • Sensation of irregular heartbeat
  • Narrowing of blood vessels in the heart
  • Blood clots
  • Flushing
  • Constipation
  • Chronic lung inflammation
  • Acid reflux
  • Gallstones
  • Liver disorders
  • Breast disorders
  • Menstrual disorders

Rare side effects (may affect up to 1 in 1,000 people):

  • Failure of bone marrow to produce blood cells
  • Severe reduction in white blood cell count
  • Joint or surrounding tissue infection
  • Poor wound healing
  • Inflammation of blood vessels in internal organs
  • Leukaemia
  • Melanoma (a type of skin tumour)
  • Merkel cell carcinoma (a type of skin tumour)
  • Lichenoid reactions (itchy purple-red rash and/or white-grey thread-like lines on mucous membranes)
  • Skin peeling
  • Immunological disorders affecting the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
  • Pain and discolouration in fingers or toes
  • Taste disturbances
  • Bladder disorders
  • Kidney disorders
  • Inflammation of blood vessels in the skin causing a rash

Side effects with unknown frequency:

  • A rare blood tumour mainly affecting young people (hepatosplenic T-cell lymphoma)
  • Kaposi’s sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi’s sarcoma most commonly presents with purple skin lesions
  • Worsening of a condition called dermatomyositis (which presents as a rash associated with muscle weakness)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Simponi

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the label and on the carton after “Exp”. The expiry date refers to the last day of that month.
  • Store in a refrigerator (2 °C–8 °C). Do not freeze.
  • Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
  • This medicine may also be stored outside the refrigerator at temperatures up to a maximum of 25 °C for a single period of up to 30 days, but not beyond the original expiry date printed on the carton. Write the new expiry date on the carton indicating day/month/year (no more than 30 days after the medicine has been removed from the refrigerator). Do not re-refrigerate this medicine once it has reached room temperature. Dispose of this medicine if not used by the new expiry date or by the printed expiry date on the carton, whichever comes first.
  • Do not use this medicine if you notice that the liquid is not clear to slightly yellow, appears cloudy, or contains foreign particles.
  • Do not dispose of any medicine via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Simponi contains
The active substance is golimumab. One pre-filled syringe of 1 mL contains 100 mg of golimumab.
The other ingredients are sorbitol (E420), histidine, histidine hydrochloride monohydrate, polysorbate 80 (E433), and water for injections. For further information on sorbitol (E420) and polysorbate 80 (E433), see section 2.

Description of the appearance of Simponi and contents of the pack
Simponi is supplied as an injectable solution in a single-use pre-filled syringe. Simponi is available in packs containing 1 pre-filled syringe and multipacks containing 3 (3 packs of 1) pre-filled syringes. Not all pack sizes may be marketed.
The solution is from clear to slightly opalescent (pearly appearance), from colourless to pale yellow, and may contain a few small translucent or white protein particles.
Do not use Simponi if the solution has changed colour, is cloudy, or contains visible foreign particles.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB "JOHNSON & JOHNSON"
Tel/Tél: 0800 93 377 Tel: +370 5 278 68 88
[email protected] [email protected]

България Luxembourg/Luxemburg
"Джонсън & Джонсън България" ЕООД Janssen-Cilag NV
Tel: +359 2 489 94 00 Tél/Tel: 800 29 504
[email protected] [email protected]

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD
Tlf.: +45 4594 8282 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: 0800 242 42 42
[email protected] [email protected]

Eesti Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]

Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε. Tel: +43 1 610 300
Tηλ: +30 210 80 90 000

España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.: +48 22 237 60 00
[email protected]

France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected] [email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor ehf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]

Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Τηλ: +357 22 207 700 Tfn: +46 8 626 50 00
[email protected]

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561
[email protected]

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

INSTRUCTIONS FOR USE

If you wish to self-inject Simponi, you must be trained by a healthcare professional on how to
prepare and administer the injection yourself. If you have not been trained, please contact your doctor,
nurse, or pharmacist to schedule a training session.
These instructions include:

  1. Preparation for using the prefilled syringe
  2. Choosing and preparing the injection site
  3. Injecting the medicine
  4. After the injection

The following figure (see Figure 1) shows what the prefilled syringe looks like.

Technical diagram of a syringe with labels indicating plunger, barrel, needle, protective cap, viewing window, and activation clip

Figure 1

1. Preparation for using the prefilled syringe

Hold the prefilled syringe by the barrel of the syringe

  • Do not hold it by the plunger tip, the plunger, the needle guard wings, or the needle cap.
  • Never pull back the plunger.
  • Never shake the prefilled syringe.
  • Do not remove the needle cap from the prefilled syringe until instructed to do so.
  • Do not touch the needle safety activation clips (indicated by asterisks * in Figure 1) to avoid premature activation of the needle safety guard.

Check the number of prefilled syringes
Check the prefilled syringes to ensure that

  • the number of syringes and the dosage are correct.
    • If your dose is 100 mg, you will use one 100 mg prefilled syringe.
    • If your dose is 200 mg, you will use two 100 mg prefilled syringes and administer two injections. Choose different injection sites for these injections and perform the injections one after the other.

Check the expiration date (see Figure 2)

  • Check the expiration date printed or written on the box.
  • Check the expiration date (indicated by “Exp.”) on the label by looking through the viewing window located on the syringe barrel.
  • If you cannot see the expiration date through the viewing window, hold the prefilled syringe by the barrel and rotate the needle cap until the expiration date aligns with the viewing window.

Do not use the prefilled syringe if the expiration date has passed. The printed expiration date refers to the last day of the month. Contact your doctor or pharmacist for assistance.

Two hands holding a syringe with curved arrows indicating rotational movement to prepare the medical device

Figure 2
Wait 30 minutes to allow the prefilled syringe to reach room temperature

  • To ensure proper injection, leave the prefilled syringe at room temperature outside the box for 30 minutes, out of the reach of children. Do not warm the prefilled syringe in any other way (for example, do not warm it in a microwave or in hot water). Do not remove the needle cap of the prefilled syringe while allowing it to warm to room temperature.

Prepare the remaining supplies
While waiting, prepare the remaining supplies, including an alcohol swab, a cotton ball or gauze, and a sharps container.
Check the liquid in the prefilled syringe

  • Hold the prefilled syringe by the barrel, with the covered needle pointing downward.
  • Look at the liquid through the viewing window of the prefilled syringe and make sure it is clear to slightly opalescent (pearl-like) and colorless to pale yellow. The solution may be used if it contains a few small translucent or white protein particles.
  • If you cannot see the liquid through the viewing window, hold the prefilled syringe by the barrel and rotate the needle cap until the liquid aligns with the viewing window (see Figure 2). Do not use the prefilled syringe if the solution is not the correct color, if it is cloudy, or if it contains larger particles. In this case, contact your doctor or pharmacist.

2. Selection and preparation of the injection site (see Figure 3)

  • The medicine is usually injected in the middle of the thigh, on the front side.
  • You may also use the lower part of the abdomen (abdominal area) below the navel, except for the area within approximately 5 cm directly below the navel.
  • Do not administer the injection in areas where the skin is tender, bruised, red, scaly, hard, or has scars or stretch marks.
  • If multiple injections are required for a single dose, the injections should be given at different body sites.
Line drawing of a male torso showing two gray areas for

Figure 3
Injection site selection for the caregiver (see Figure 4)

  • If the injection is to be administered by the person assisting the patient, the outer area of the upper arm may also be used.
  • All the sites mentioned above may be used regardless of body type or size.
Schematic drawing of a male torso with a gray circle indicating the application site on the upper part of the right arm

Figure 4
Preparation of the injection site

  • Wash your hands thoroughly with soap and warm water.
  • Clean the injection site with an alcohol swab.
  • Allow the skin to dry completely before injecting. Do not blow on or fan the cleaned area. Do not touch this area before giving the injection.

3. Injection of the medicine

The needle cap should only be removed when you are ready to inject the medicine.
The medicine must be injected within 5 minutes after removing the protective needle cap.
Do not touch the plunger when removing the protective needle cap.
Remove the protective needle cap (see Figure 5)

  • When you are ready to inject, hold the pre-filled syringe body in one hand.
  • Pull the protective needle cap straight off and dispose of it after injection. Do not touch the plunger during this step.
  • You may notice an air bubble in the pre-filled syringe or a drop of liquid at the tip of the needle. This is normal and does not need to be removed.
  • Inject the dose immediately after removing the protective needle cap.

Do not touch the needle and avoid contact with any surface.
Do not use the pre-filled syringe if it has been dropped without the protective needle cap. In this case,
contact your doctor or pharmacist.

Two hands demonstrating how to apply a protective cap to the tip of

Figure 5
Positioning the pre-filled syringe for injection

  • Hold the body of the pre-filled syringe between the middle and index fingers of one hand, place your thumb on the plunger head, and use your other hand to gently pinch the previously cleaned area of skin. Hold the syringe firmly. Never pull back on the plunger.

Injecting the medicine

  • Tilt the needle at approximately a 45-degree angle to the pinched skin. With one quick, smooth motion, insert the needle through the skin until it stops (see Figure 6).
Two drawings show the

Figure 6

  • Inject all the medicine by pushing the plunger all the way down until the plunger head is completely within the needle guard wings (see Figure 7).
Two hands holding and rotating the upper part of a medical injection pen with the expiration date visible on the device body

Figure 7

  • When the plunger stops, continue to apply pressure on the plunger head, withdraw the needle, and release the skin (see Figure 8).
A hand holds an injection pen to bring it closer to

Figure 8

  • Slowly remove your thumb from the plunger head to allow the empty pre-filled syringe to move upward until the needle is fully covered by the built-in needle shield, as shown in Figure 9:
Two hands holding a transparent cylindrical medical device with detailed internal spring mechanism and mechanical components

Figure 9

4. After the injection

Use a cotton ball or gauze

  • A small amount of blood or fluid at the injection site may occur. This is normal.
  • You may press a cotton ball or gauze pad against the injection site for 10 seconds.
  • You may cover the injection site with a small adhesive bandage if needed. Do not rub the skin.

Dispose of the prefilled syringe (see Figure 10)

  • Immediately place the prefilled syringe into a sharps disposal container. Make sure to dispose of the container according to the instructions provided by your doctor or nurse. Do not attempt to recap the needle. Never reuse the prefilled syringe—for your health and safety and for the safety of others.

If you think something went wrong with the injection, or if you are unsure, talk to your
doctor or pharmacist.

A hand holds a sharps container above a biohazard waste container with the biohazard symbol and the word BIOHAZARD

Figure 10