Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Simponi 100mg solution for injection in a pre-filled pen

golimumab

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

In addition, your doctor will provide you with a Patient Information Card containing important safety information you need to know before and during treatment with Simponi.

Leaflet contents

What Simponi is and what it is used for
What you need to know before using Simponi
How to use Simponi
Possible side effects
How to store Simponi
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, which includes 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 plays a role in inflammatory processes in the body, and blocking it may reduce inflammation.

Rheumatoid arthritis

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

Reduce the signs and symptoms of your disease.
Slow down damage to bones and joints.
Improve your 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 given other medicines. If you do not respond adequately to these medicines, Simponi may be given to you to:

Reduce the signs and symptoms of your disease.
Slow down damage to bones and joints.
Improve your 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 given other medicines. If you do not respond adequately to these medicines, Simponi may be given to you to:

Reduce the signs and symptoms of your disease
Improve your 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 you 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 apply to you, consult your doctor, pharmacist, or nurse before using Simponi.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting treatment with Simponi.

Infections

Tell your doctor immediately if you currently have or develop any signs of infection during or after treatment with Simponi. Signs of infection may include fever, cough, difficulty breathing, flu-like symptoms, diarrhoea, wounds, dental problems, or a burning sensation when urinating.

While using Simponi, you may be more likely to get infections.
Infections may progress more quickly and may be more severe. In addition, previous infections may recur.

Tuberculosis (TB)

Tell your doctor immediately if you develop symptoms of TB during or after treatment. Symptoms of TB include persistent cough, weight loss, fatigue, fever, or night sweats.

Cases of tuberculosis have been reported in patients treated with Simponi, and in rare cases even in patients who have been treated with medications for TB. Your doctor will perform tests to check whether you have TB. Your doctor will record these test results on your Patient Information Card.
It is very important that you inform your doctor if you have ever had TB or if you have had close contact with someone who has or had TB.
If your doctor believes you are at risk of developing TB, you may be treated with TB medications before starting Simponi treatment.

Hepatitis B virus (HBV)

Inform your doctor if you are a carrier of or have had or currently have hepatitis B before receiving Simponi.
Tell your doctor if you think you may be at risk of contracting HBV.
Your doctor should test you for HBV.
Treatment with TNF blockers such as Simponi may cause reactivation of hepatitis B virus in carriers of this virus, which in some cases may be potentially fatal.

Invasive fungal infections

Tell your doctor immediately if you have lived in or travelled to areas where certain types of fungal infections that can affect the lungs or other parts of the body are common (called histoplasmosis, coccidioidomycosis, or blastomycosis). If you are unsure whether these infections are common in areas where you have lived or travelled, consult your doctor.

Cancer and lymphoma

Tell your doctor if you have ever been diagnosed with lymphoma (a type of blood cancer) or any other cancer before using Simponi.

If you use Simponi or another TNF blocker, your risk of developing lymphoma or another cancer may be increased.
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.
In children and adolescents treated with TNF blockers, cases of cancer have occurred, some of which were rare types and occasionally fatal.
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 is usually fatal. Almost all of these patients had also received medications such 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 developing cancer when treated with Simponi. If you have severe persistent asthma, COPD, or are a heavy smoker, you should consult with your doctor whether treatment with a TNF blocker is appropriate for you.
Some patients treated with golimumab have developed certain types of skin cancer. Inform your doctor if you notice changes in the appearance of your skin or abnormal skin growths during or after treatment.

Heart failure

Tell your doctor immediately if you develop new symptoms of heart failure or if your existing symptoms worsen. Symptoms of heart failure include difficulty breathing or swelling of the feet.

During treatment with TNF blockers, including Simponi, new onset or worsening of congestive heart failure has been reported. Some of these patients died.
If you have mild heart failure and are being treated with Simponi, your doctor should monitor you carefully.

Nervous system disorders

Tell 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, or numbness or tingling in any part of your body. Your doctor will decide whether you should receive Simponi.

Surgery or dental procedures

Inform your doctor if you are scheduled for any surgery or dental procedure.
Inform the surgeon or dentist performing the procedure that you are being treated with Simponi by showing them your Patient Information Card.

Autoimmune disease

Tell your doctor if you develop symptoms of a condition 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 stop producing enough blood cells that help fight infections or stop bleeding. If you develop persistent fever, bruising easily, bleeding easily, or paleness, inform your doctor immediately. Your doctor may decide to stop treatment.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before using Simponi.

Vaccinations

Inform your doctor if you have been vaccinated or are planning to be vaccinated.

You should not receive certain vaccines (live vaccines) while using Simponi.
Some vaccines may cause infections. If you received Simponi treatment during pregnancy, your baby may have an increased risk of contracting such infections for approximately six months after your last dose received during pregnancy. It is important to inform your baby's doctors and other healthcare professionals about your Simponi treatment so they can determine when your baby should be vaccinated.

Therapeutic infectious agents

Inform your doctor if you have recently received or are scheduled to receive treatment with therapeutic infectious agents (such as BCG instillation used for cancer treatment).

Allergic reactions

Tell your doctor immediately if you develop symptoms of an allergic reaction after receiving 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 the hands, feet, or ankles.

Some of these reactions may be serious or, rarely, potentially fatal.
Some of these reactions occurred after the first administration of Simponi.

Children and adolescents

Simponi 100 mg is not recommended for use in 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 need to take any other medicines, including other medicines used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
You must not use 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 your immune system.
You should not receive certain vaccines (live virus vaccines) while being treated with Simponi.

If you are unsure whether you are taking any of the medicines mentioned above, consult 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. There is limited information on the effects of this medicine in pregnant women. If you are being treated with Simponi, you should avoid pregnancy by using effective contraceptive methods during treatment and for at least 6 months after the last injection of Simponi. Simponi should only be used during pregnancy if strictly necessary.
At least 6 months must have passed since your last Simponi treatment before starting breastfeeding. You must stop breastfeeding if you are to be given Simponi.
If you received Simponi treatment during pregnancy, your baby may have an increased risk of infection. It is important to inform your baby's doctors and other healthcare professionals about your Simponi treatment before your baby receives any vaccinations (see the section on vaccinations for more information).

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Simponi has minor influence on the ability to drive and use machines. However, dizziness may occur after administration of Simponi. If this occurs, do not drive or operate any tools or machinery.

Simponi contains latex and sorbitol

Latex sensitivity

A part of the pre-filled pen, the needle cap, contains latex. Since latex may cause severe allergic reactions, consult your doctor before using Simponi if you or your caregiver are allergic to latex.

Sorbitol intolerance

This medicine contains 41 mg of sorbitol (E-420) in each pre-filled pen.

3. How to use Simponi

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

What dose of 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 administering the fourth dose. Your doctor will determine whether you should continue treatment with Simponi.
- If you weigh more than 100 kg, the dose may be increased up to 100 mg (the content of 1 pre-filled pen) administered once a month, on the same day each month.

Ulcerative colitis

The following table shows how you will usually use this medicine.

Initial treatment

An initial dose of 200 mg (the contents of 2 pre-filled pens) followed by 100 mg (the contents of 1 pre-filled pen) 2 weeks later.

Maintenance treatment

For patients weighing less than 80 kg, 50 mg (to administer this dose, use the contents of 1 pre-filled pen or 1 pre-filled syringe of 50 mg) 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), depending on your response to Simponi.
For 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 subcutaneous injection (under the skin).
Initially, your doctor or nurse may give you the Simponi injection. However, you and your doctor may decide that you can self-inject Simponi. In this case, you will be instructed on how to self-administer the Simponi injection.

Consult your doctor if you have any questions about how to self-administer an injection. Detailed “Instructions for Use” can be found at the end of this leaflet.

If you use more Simponi than you should

If you have used or have been given too much Simponi (given too much in a single injection or used it too frequently), consult your doctor or pharmacist immediately. Always carry the outer packaging, even if it is empty, and this leaflet with you.

If you forget to use Simponi

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

Do not administer a double dose to make up for the missed dose.

When to inject the next dose:

If the dose is delayed by less than 2 weeks, inject the missed dose as soon as you remember and continue with your original schedule.
If the dose is delayed by more than 2 weeks, inject the missed dose as soon as you remember and consult your doctor or pharmacist to determine when the next dose should be administered.

If you are unsure 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 further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

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

Allergic reactions, which may be serious, or rarely, potentially fatal (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) (frequent). Symptoms of infection may include fever, fatigue, (persistent) cough, difficulty breathing, flu-like symptoms, weight loss, night sweats, diarrhea, 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 eyes and skin, dark brown urine, abdominal pain on the right side, fever, feeling dizzy, vomiting, and feeling very tired.
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 your 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 difficulty breathing or swelling of your 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 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 abnormal skin growth.
Blood disorders (frequent). Symptoms of blood disorders may include persistent fever, bruising easily, or excessive bleeding or paleness.
Blood cancer (leukemia) (rare). Symptoms of leukemia may include fever, feeling tired, frequent infections, easy bruising, and night sweats.

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

The following additional adverse effects have been observed with Simponi:

Very common adverse effects (may affect more than 1 in 10 patients):

Upper respiratory tract infections, sore throat or hoarseness, runny nose

Common adverse effects (may affect up to 1 in 10 patients):

Abnormal liver function tests (increased liver enzymes) detected during blood tests ordered by your doctor
Dizziness
Headache
Numbness or tingling sensation
Superficial fungal infections
Abscess
Bacterial infections (such as cellulitis)
Low red blood cell count
Low white blood cell count
Positive blood test for lupus
Allergic reactions
Indigestion
Stomach pain
Feeling unwell (nausea)
Flu
Bronchitis
Sinusitis
Herpes
High blood pressure
Fever
Asthma, feeling of suffocation, difficulty breathing
Stomach and intestinal disorders including inflammation of the inner lining of the stomach and colon, which may cause fever
Mouth pain and sores
Injection site reactions (including redness, hardness, pain, bruising, itching, tingling, and irritation)
Hair loss
Skin rash and itching
Difficulty sleeping
Depression
Weakness
Bone fractures
Chest discomfort

Uncommon adverse effects (may affect up to 1 in 100 patients):

Kidney infection
Cancers, such as skin cancer and non-cancerous tumors or lumps, including moles
Blisters on the skin
Serious body-wide infection (sepsis), sometimes including low blood pressure (septic shock)
Psoriasis (including on the palms of the hands and/or soles of the feet and/or types that present with blisters on the skin)
Low platelet count
Combined low count of platelets, red blood cells, and white blood cells
Thyroid disorders
Increased blood sugar levels
Increased blood cholesterol levels
Balance disorders
Visual disturbances
Eye inflammation (conjunctivitis)
Eye allergy
Sensation of irregular heartbeat
Narrowing of blood vessels in the heart
Blood clots
Flushing
Constipation
Chronic inflammatory lung disease
Reflux
Gallstones
Liver disorders
Breast disorders
Menstrual cycle disorders

Rare adverse effects (may affect up to 1 in 1,000 patients):

Bone marrow failure to produce blood cells
Severe decrease in the number of white blood cells in the blood
Infection of joints or surrounding tissue
Wound healing problems
Inflammation of blood vessels in internal organs
Leukemia
Melanoma (a type of skin cancer)
Merkel cell carcinoma (a type of skin cancer)
Lichenoid reactions (pruritic reddish-purple rash and/or thick whitish-grey lines on mucous membranes)
Scaly and peeling skin
Immune system disorders that could affect the lungs, skin, and lymph nodes (usually presenting as sarcoidosis)
Pain and discoloration in fingers or toes
Taste disturbances
Bladder disorders
Kidney disorders
Inflammation of blood vessels in the skin causing rash

Adverse effects with unknown frequency:

A rare blood cancer affecting mainly young people (hepatosplenic T-cell lymphoma)
Kaposi’s sarcoma, an uncommon cancer related to human herpesvirus 8 infection. Kaposi’s sarcoma usually presents more frequently as purplish skin lesions
Worsening of a disease called dermatomyositis (manifested as a rash accompanied by muscle weakness)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 packaging after “EXP”. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.
Keep the pre-filled pen in the outer packaging to protect it 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, including day/month/year (no more than 30 days after the medicine is removed from the refrigerator). Once the medicine has reached room temperature, do not return it to the refrigerator. Dispose of this medicine if it has not been used by the new expiry date or by the original expiry date printed on the carton, whichever comes first.
Do not use this medicine if you notice that the liquid is not clear or pale yellow, if it is cloudy, or if it contains foreign particles.
Medicines must not be disposed of via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Simponi

The active substance is golimumab. A 1 ml pre-filled pen contains 100 mg of golimumab.

The other components are sorbitol (E-420), histidine, histidine monohydrochloride monohydrate, polysorbate 80, and water for injections. For further information on sorbitol (E-420), see section 2.

Appearance of the product and contents of the container

Simponi is presented as a solution for injection in a single-use pre-filled pen. Simponi is available in packs containing 1 pre-filled pen and multiple packs containing 3 pre-filled pens (3 packs of 1). Only certain pack sizes may be marketed.

The solution is from transparent to slightly opalescent (with a pearly sheen), colourless to pale yellow, and may contain small translucent or white protein particles. Do not use Simponi if the solution changes colour, becomes cloudy, or if foreign particles are visible in it.

Marketing Authorization Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340

Belgium

Manufacturer

Janssen Biologics B.V.

Einsteinweg 101

2333 CB Leiden

The Netherlands

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Belgium/Belgique/Belgien

Janssen-Cilag NV

Tel/Tél: +32 14 64 94 11

Simponi 100 mg solution for injection in pre-filled pen