Gobivaz

Package leaflet: Information for the user

GOBIVAZ 50 mg solution for injection in pre-filled pen

golimumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
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, contact your doctor, pharmacist or nurse. See section 4.

Your doctor will provide you with a Patient Reminder Card containing important safety information that you should be aware of before and during treatment with GOBIVAZ.

Contents of this leaflet

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

1. What GOBIVAZ is and what it is used for

GOBIVAZ contains an active substance called golimumab.
GOBIVAZ 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, GOBIVAZ is used to treat polyarticular juvenile idiopathic arthritis.
GOBIVAZ 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 affecting 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 GOBIVAZ 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 joint disease, usually accompanied by psoriasis, a skin inflammatory 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 GOBIVAZ 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 GOBIVAZ to:

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

Ulcerative colitis
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, you will be given GOBIVAZ to treat your condition.

Polyarticular juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis is an inflammatory disease causing 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 GOBIVAZ in combination with methotrexate to treat the disease.

2. What you should know before using GOBIVAZ

Do not use GOBIVAZ

• 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 GOBIVAZ.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GOBIVAZ.
Infections
Inform your doctor immediately if you have had or develop symptoms of infection during or after treatment with GOBIVAZ. 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 GOBIVAZ.
• 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 GOBIVAZ, occasionally even in patients who had been treated with medications for TB. Your doctor will perform tests to assess whether you have TB. Your doctor will record these tests on the Patient Reminder 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 medications for TB before starting GOBIVAZ.

Hepatitis B virus (HBV)

• Inform your doctor if you are a carrier of, or have or have had hepatitis B, before being given GOBIVAZ.
• Inform your doctor if you believe 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 GOBIVAZ may cause reactivation of 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 tumours before being given GOBIVAZ.

• Your risk of developing lymphoma or another type of tumour may increase if you use GOBIVAZ 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 treated with TNF-blocking 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 GOBIVAZ.
• Patients with severe persistent asthma, chronic obstructive pulmonary disease (COPD), or regular smokers may have an increased risk of cancer with treatment with GOBIVAZ. 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 or worsening congestive heart failure have been reported with TNF blockers, including GOBIVAZ. Some of these patients have died.
• If you have mild heart failure and are treated with GOBIVAZ, 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, or numbness or tingling anywhere in the body. Your doctor will decide whether you should be given GOBIVAZ.
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 GOBIVAZ, and show them your Patient Reminder 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 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 GOBIVAZ.
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 GOBIVAZ.
• Some vaccinations may cause infections. If you received GOBIVAZ 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 GOBIVAZ so they can decide when the baby should receive any vaccine.

Talk to your child’s doctor about vaccinations for your child. If possible, the child should be up to date with all vaccinations before using GOBIVAZ.
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 GOBIVAZ. 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 administration of GOBIVAZ.

Children
GOBIVAZ 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 GOBIVAZ

• 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 GOBIVAZ 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) while using GOBIVAZ.

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

• You are pregnant or planning a pregnancy during treatment with GOBIVAZ. Limited information is available on the effects of this medicine in pregnant women. If you need to be treated with GOBIVAZ, you should avoid pregnancy by using an adequate contraceptive method during treatment and for at least 6 months after the last injection of GOBIVAZ. GOBIVAZ 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 GOBIVAZ. You must stop breastfeeding if you are to be given GOBIVAZ.
• If you received GOBIVAZ 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 GOBIVAZ 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
GOBIVAZ has a minor influence on the ability to drive and use machines. After using GOBIVAZ, dizziness may occur. In this case, do not drive or use tools or machines.
GOBIVAZ contains sorbitol
Sorbitol intolerance
This medicine contains 20.5 mg of sorbitol in each pre-filled pen.

3. How to use GOBIVAZ

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Dosage of GOBIVAZ
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 GOBIVAZ.
• 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 with a body weight of at least 40 kg, 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 GOBIVAZ.

Ulcerative colitis

• The table below shows how you will generally use this medicine.

How GOBIVAZ is administered

• GOBIVAZ is administered by injection under the skin (subcutaneously).
• Initially, your doctor or nurse will inject GOBIVAZ for you. However, you and your doctor may decide that you can self-inject GOBIVAZ. In this case, you will be trained on how to inject GOBIVAZ. 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 GOBIVAZ than you should
If you have used or been administered too much GOBIVAZ (by injecting too much in a single dose or using it too frequently), inform your doctor or pharmacist immediately. Always carry the outer packaging and this leaflet with you, even if empty.
If you forget to use GOBIVAZ
If you forget to use GOBIVAZ 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 GOBIVAZ
If you are considering stopping treatment with GOBIVAZ, 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 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 GOBIVAZ, which include:

• 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 GOBIVAZ.
• Serious infections (including TB, bacterial infections including severe blood infections and pneumonia, severe 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, 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 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 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 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 GOBIVAZ:
Very common side effects (may affect more than 1 in 10 people):

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

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

• Liver test abnormalities (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
• Cold sores
• 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
• 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 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 discoloration in fingers of the hand or foot
• 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 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 GOBIVAZ

• 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 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 its 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 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 GOBIVAZ contains
The active substance is golimumab. One pre-filled pen contains 50 mg of golimumab.
The other components are sorbitol, L-histidine, L-histidine monohydrochloride monohydrate, poloxamer 188,
and water for injections. For more information about sorbitol, see section 2.

Description of the appearance of GOBIVAZ and contents of the pack
GOBIVAZ is supplied as an injectable solution in a single-use pre-filled pen. GOBIVAZ is available in packs containing 1 pre-filled pen and multipacks containing 3 pre-filled pens (3 packs of 1). Not all pack sizes may be marketed.
The solution ranges 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 GOBIVAZ if the solution has changed colour, is cloudy, or contains visible foreign particles.

Marketing Authorisation Holder
Advanz Pharma Limited
Unit 17 Northwood House
Northwood Crescent
Dublin 9
D09 V504
Ireland

Manufacturer
Alvotech Hf
Sæmundargata 15-19
Reykjavik, 102
Iceland

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

If you wish to self-inject GOBIVAZ, you must be trained by a healthcare professional on how to
prepare and administer an injection by 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. Choosing and preparing the injection site
3. Administering the medicine
4. After the injection

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

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 blister pack

• Check the security seal on the blister pack lid.
• Do not use the pre-filled pen if the blister pack is damaged. 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 (for example, 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 swab, a cotton ball or gauze, and a sharps container.

Check the liquid in the pre-filled pen

• Look through the viewing window and make sure that the liquid in the pre-filled pen 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.
• You may also notice a small air bubble, but this 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 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 dose, the injections must be given at different injection sites.

Injectable areas
Figure 2

• DO NOT inject into the arm to avoid malfunction of the pre-filled pen and/or accidental injuries.

Handwashing 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 before injecting. Do not blow on or fan the cleaned area.
• Do not touch this area before giving 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 you are ready to inject, pull the cap straight off and discard 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.

Figure 3
Prepare to press the pre-filled pen against the skin (see Figure 4).

Figure 4

• With your other hand, pinch the skin. Prepare to place the pre-filled pen onto the injection site so that the orange needle safety sleeve is facing toward the injection site.
• Hold the pen so that you can see the viewing window.

Press to inject (see Figure 5).

Figure 5

• Press the open end of the pre-filled pen firmly against the skin at a 90-degree angle. (See Figure 5.)
• Wait for the first “click,” which indicates the start of the injection. You may or may not feel the needle entering the skin.
• Begin counting slowly to 15 to ensure the full dose is delivered.

Do not lift the pre-filled pen from the skin. If you lift the pre-filled pen from the skin prematurely,
you may not have delivered the complete dose of medication.
Continue pressing until the orange indicator stops moving or you hear the
second “click” (see Figure 6). It may take up to 15 seconds to hear the second
“click” (indicating the injection is complete and the needle has retracted into the pre-filled pen).

Figure 6

• Note: If you do not hear the second “click,” wait 15 seconds from the time you first pressed the pre-filled pen against the skin, then remove the autoinjector from the injection site.

Check the viewing window – an orange indicator confirms successful administration
(see Figure 7)

• The orange indicator should completely cover the viewing window.
• Lift the pre-filled pen away from the injection site.
• Speak with your doctor or pharmacist if the orange indicator is not visible in the window or if you suspect you did not receive the full dose. Do not administer a second dose without first consulting your doctor.

Figure 7

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.
• If needed, you may cover the injection site with a small adhesive bandage.
• Do not rub the skin.

Dispose of the pre-filled pen (see Figure 8)

• 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.

Figure 8

Package leaflet: Information for the user

GOBIVAZ 50 mg solution for injection in pre-filled syringe

golimumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
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 they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

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

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

1. What GOBIVAZ is and what it is used for

GOBIVAZ contains an active substance called golimumab.
GOBIVAZ 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, GOBIVAZ is used to treat polyarticular juvenile idiopathic arthritis.
GOBIVAZ 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 affecting 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 GOBIVAZ in combination with another medicine called methotrexate to:

• Reduce the signs and symptoms of the disease.
• Slow down joint and bone damage.
• Improve physical function.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, a skin inflammatory 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 GOBIVAZ to:

• Reduce the signs and symptoms of the disease.
• Slow down joint and bone damage.
• 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 GOBIVAZ 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, you will be given GOBIVAZ to treat your disease.

Polyarticular juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis is an inflammatory disease causing 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 GOBIVAZ in combination with methotrexate to treat the disease.

2. What you should know before using GOBIVAZ

Do not use GOBIVAZ

• 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, discuss this with your doctor, pharmacist, or nurse before using GOBIVAZ.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GOBIVAZ.
Infections
Inform your doctor immediately if you have had or develop symptoms of infection during or after treatment with GOBIVAZ. Symptoms of infection include fever, cough, shortness of breath, flu-like symptoms, diarrhea, wounds, dental problems, or a burning sensation when urinating.

• You may be more likely to get infections while using GOBIVAZ.
• 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 GOBIVAZ, occasionally even in patients who have been treated with medications for TB. Your doctor will perform tests to assess whether you have TB. These tests will be recorded by your doctor on the Patient Reminder 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 medications for TB before receiving GOBIVAZ.

Hepatitis B virus (HBV)

• Inform your doctor if you are a carrier of or have or have had hepatitis B before being administered GOBIVAZ.
• 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 GOBIVAZ 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 traveled 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 traveled.
Cancer 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 administered GOBIVAZ.

• Your risk of developing lymphoma or another type of cancer may increase if you use GOBIVAZ 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.
• In children and adolescent patients treated with TNF blocker medicines, cases of cancer, including unusual types, have been reported, sometimes 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 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 GOBIVAZ.
• Patients with severe persistent asthma, chronic obstructive pulmonary disease (COPD), or who are regular smokers may have an increased risk of cancer with treatment with GOBIVAZ. 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 you notice any changes in the appearance of your skin or skin growths 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 GOBIVAZ. Some of these patients died.
• If you have mild heart failure and are treated with GOBIVAZ, 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 you should be treated with GOBIVAZ.
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 GOBIVAZ, and show them your Patient Reminder 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, 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, discuss this with your doctor or pharmacist before using GOBIVAZ.
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 GOBIVAZ.
• Some vaccinations may cause infections. If you received GOBIVAZ during pregnancy, your baby may have an increased risk of contracting such infections for approximately six months after your last dose during pregnancy. It is important to inform the pediatrician and other healthcare providers about the use of GOBIVAZ so they can determine 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 GOBIVAZ.
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 GOBIVAZ. 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 administration of GOBIVAZ.

Children
GOBIVAZ 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 GOBIVAZ

• 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 GOBIVAZ 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 acts on the immune system.
• You cannot receive certain vaccines (live) while using GOBIVAZ.

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

• You are pregnant or planning a pregnancy during treatment with GOBIVAZ. Limited information is available on the effects of this medicine in pregnant women. If you need to be treated with GOBIVAZ, you should avoid pregnancy by using an adequate method of contraception during treatment and for at least 6 months after the last injection of GOBIVAZ. GOBIVAZ should be used during pregnancy only if strictly necessary for you.
• Breastfeeding should be delayed until at least 6 months have passed since your last treatment with GOBIVAZ. You must stop breastfeeding if you are to be administered GOBIVAZ.
• If you received GOBIVAZ during pregnancy, your baby may have an increased risk of contracting an infection. It is important to inform the pediatrician and other healthcare providers about the use of GOBIVAZ 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, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
GOBIVAZ has a minor influence on the ability to drive and use tools or machines. However, dizziness may occur after using GOBIVAZ. In this case, do not drive or operate tools or machinery.
GOBIVAZ contains sorbitol
Sorbitol intolerance
This medicine contains 20.5 mg of sorbitol in each pre-filled syringe.

3. How to use GOBIVAZ

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much GOBIVAZ 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 GOBIVAZ.
  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 children aged 2 years and older:

• In patients weighing at least 40 kg, 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 GOBIVAZ.

Ulcerative colitis

• The table below shows how you will generally use this medicine.

How GOBIVAZ is administered

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

If you use more GOBIVAZ than you should
If you have used or have been given too much GOBIVAZ (by injecting too much in a single dose, 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 GOBIVAZ
If you forget to use GOBIVAZ 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 and inform 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 treatment with GOBIVAZ
If you are considering stopping treatment with GOBIVAZ, speak to 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. 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 GOBIVAZ, which include:

• 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 GOBIVAZ.
• 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 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 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 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.

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

The following additional side effects have been observed with GOBIVAZ

Side effects very common (may affect more than 1 in 10 people):

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

Side effects common (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
• Cold sores
• 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

Side effects uncommon (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

Side effects rare (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 discolouration in fingers of the hands or feet
• 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 get any side effects, including ones 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 GOBIVAZ

• 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 syringe in its 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 original expiry date printed 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 GOBIVAZ contains
The active substance is golimumab. A 0.5 mL pre-filled syringe contains 50 mg of golimumab. The
other components are sorbitol, histidine, L-histidine monohydrochloride monohydrate, poloxamer 188 and
water for injections. For more information on sorbitol, see section 2.
Description of the appearance of GOBIVAZ and contents of the pack
GOBIVAZ is supplied as an injectable solution in a single-use pre-filled syringe. GOBIVAZ 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 (pearl-like sheen), colourless to pale yellow, and may contain a few small translucent or white protein particles.
Do not use GOBIVAZ if the solution has changed colour, is cloudy, or contains visible foreign particles.
Marketing Authorisation Holder
Advanz Pharma Limited
Unit 17 Northwood House
Northwood Crescent
Dublin 9
D09 V504
Ireland
Manufacturer
Alvotech Hf
Sæmundargata 15-19
Reykjavik, 102
Iceland
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 GOBIVAZ, you must be trained by a healthcare professional on how to
prepare and administer the injection 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 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 pre-filled syringe looks like.

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 or by the needle protective cap.
• Never pull back the plunger.
• Never shake the prefilled syringe.
• Do not remove the needle protective cap from the prefilled syringe until instructed to do so.

Check the number of prefilled syringes
Check the prefilled syringes to make sure that:

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

Check the expiration date (see Figure 2)

• Check the expiration date printed or written on the box and on the blister pack.
• Check the expiration date (indicated by “Exp.”) on the label on the barrel of the prefilled syringe.
• 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.

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

• To ensure proper injection, leave the prefilled syringe outside the box at room temperature 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 protective cap while allowing the syringe to warm to room temperature.

Prepare the remaining supplies
While waiting, prepare the rest of the necessary 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 inspection window of the prefilled syringe and make sure it 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.
• If you cannot see the liquid through the inspection window, hold the prefilled syringe by the barrel and rotate the needle protective 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 thigh, on the front side.
• 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 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 administration, they must be given at different body sites.

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 mentioned sites can be used regardless of body type or size.

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 administering the injection.

3. Injection of the Medicinal Product

The needle protective cap must be removed only 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 to inject, hold the pre-filled syringe body in one hand.
• Pull the needle protective cap straight off and dispose of it after the injection. Do not touch the plunger during this process.
• 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 must not be removed.
• Inject the dose immediately after removing the needle protective cap.

Do not touch the needle and avoid letting it come into 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.

Figure 5
Positioning the pre-filled syringe for injection

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

Injecting the medicine

• Insert the needle at an angle of approximately 45 degrees to the pinched skin. In one quick, single motion, insert the needle through the skin until it stops (see Figure 6).

Figure 6

• Release the skin and reposition your hand. Use your free hand to grasp the body of the pre-filled syringe. Position your thumb on the plunger and press it down completely until it stops (see Figure 7).

Figure 7

• Stop applying pressure to the plunger; the automatic safety shield will then cover and lock the needle. Remove the needle from the skin (see Figure 8).

Figure 8

4. After the injection

Use a cotton ball or gauze

• You may see 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 pre-filled syringe (see Figure 10)

• Immediately place the pre-filled 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 pre-filled syringe, for your safety and the safety of others.

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

Figure 9

Patient Information Leaflet: Information for the User

GOBIVAZ 100 mg solution for injection in a prefilled pen

golimumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine, as 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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

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

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

1. What GOBIVAZ is and what it is used for

GOBIVAZ contains an active substance called golimumab.
GOBIVAZ 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

GOBIVAZ 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 GOBIVAZ in combination with another medicine called
methotrexate to:

• Reduce the signs and symptoms of the disease.
• Slow down joint and bone damage.
• 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
GOBIVAZ to:

• Reduce the signs and symptoms of the disease.
• Slow down joint and bone damage.
• 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 GOBIVAZ to:

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

Ulcerative colitis
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, you will be
given GOBIVAZ to treat your disease.

2. What you should know before using GOBIVAZ

Do not use GOBIVAZ

• 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 GOBIVAZ.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GOBIVAZ.
Infections
Tell your doctor immediately if you have ever had an infection or if you develop symptoms of infection during or after treatment with GOBIVAZ. Symptoms of infection include fever, cough, shortness of breath, flu-like symptoms, diarrhea, wounds, dental problems, or a burning sensation when urinating.

• You may be more likely to get infections while using GOBIVAZ.
• Infections may progress more quickly and become 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 persistent cough, weight loss, feeling tired, fever, or night sweats.

• Cases of TB have been reported in patients treated with GOBIVAZ, rarely even in patients who have been treated with medications for TB. Your doctor will perform tests to assess whether you have TB. These tests will be recorded by your doctor on the Patient Reminder 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 medications for TB before starting GOBIVAZ.

Hepatitis B virus (HBV)

• Inform your doctor if you are a carrier of, or have or have had hepatitis B, before being given GOBIVAZ.
• 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 GOBIVAZ can cause reactivation of the hepatitis B virus in patients who are carriers of this virus, which in some cases can lead to death.

Invasive fungal infections
Inform your doctor immediately if you have lived in or traveled to areas 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 areas where you have lived or traveled.
Cancer 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 GOBIVAZ.

• Your risk of developing lymphoma or another type of cancer may increase if you use GOBIVAZ 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-blocking 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 GOBIVAZ.
• Patients with severe persistent asthma, chronic obstructive pulmonary disease (COPD), or habitual smokers may have an increased risk of cancer with treatment with GOBIVAZ. 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 you notice any changes in the appearance of your skin or skin growths 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 pre-existing heart failure have been reported with TNF blockers, including GOBIVAZ. Some of these patients have died.
• If you have mild heart failure and are treated with GOBIVAZ, your doctor will closely monitor you.

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 and legs, numbness, or tingling anywhere in the body. Your doctor will decide whether you should be given GOBIVAZ.
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 GOBIVAZ, and show them your Patient Reminder 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 stop bleeding. If you develop unexplained persistent fever, bruise easily, bleed easily, or appear 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 GOBIVAZ.
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 GOBIVAZ.
• Some vaccinations may cause infections. If you received GOBIVAZ during pregnancy, your 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 your pediatrician and other healthcare providers about the use of GOBIVAZ so they can decide when your 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 for cancer treatment).
Allergic reactions
Tell your doctor immediately if you develop symptoms of an allergic reaction after treatment with GOBIVAZ. 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 can be serious or, rarely, life-threatening.
• Some of these reactions have occurred after the first dose of GOBIVAZ.

Children and adolescents
GOBIVAZ 100 mg is not recommended for the treatment of children and adolescents (under 18 years of age).
Other medicines and GOBIVAZ

• 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 GOBIVAZ 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) while using GOBIVAZ.

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

• You are pregnant or planning a pregnancy during treatment with GOBIVAZ. Limited information is available on the effects of this medicine in pregnant women. If you need to be treated with GOBIVAZ, you must avoid pregnancy by using an effective method of contraception during treatment and for at least 6 months after the last injection of GOBIVAZ. GOBIVAZ should be used during pregnancy only if strictly necessary for you.
• Breastfeeding should not occur until at least 6 months after your last treatment with GOBIVAZ. You must stop breastfeeding if you are to be given GOBIVAZ.
• If you received GOBIVAZ during pregnancy, your baby may have an increased risk of contracting an infection. It is important to inform your pediatrician and other healthcare providers about the use of GOBIVAZ before your baby receives any vaccine (for more information, see the section on vaccinations). If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
GOBIVAZ has a minor influence on the ability to drive and use machines. After using GOBIVAZ, dizziness may occur. In this case, do not drive or operate tools or machinery.
GOBIVAZ contains sorbitol
Sorbitol intolerance
This medicine contains 41 mg of sorbitol in each pre-filled pen.

3. How to use GOBIVAZ

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

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 GOBIVAZ.
• 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.

How GOBIVAZ is administered

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

If you use more GOBIVAZ than you should
If you have used or been given too much GOBIVAZ (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 empty.

If you forget to use GOBIVAZ
If you forget to use GOBIVAZ 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 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 GOBIVAZ
If you are considering stopping treatment with GOBIVAZ, speak to 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 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.

Contact your doctor immediately if you notice any of the following serious side effects of GOBIVAZ, which include:

• 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 GOBIVAZ.

• Serious infections (including TB, bacterial infections including severe blood infections and pneumonia, serious fungal infections and other opportunistic infections) (common). Symptoms of an 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.

• Cancer of the lymph nodes (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 fever that does not go away, a marked 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.

Contact your doctor immediately if you notice any of the symptoms listed above.
The following additional side effects have been observed with GOBIVAZ:
Very common side effects (may affect more than 1 in 10 people):

• Respiratory tract infections, sore throat or hoarseness, common cold

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

• Liver test abnormalities (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
• Cold sores (herpes labialis)
• 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), 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 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 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 appears as 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 get any side effects, including any 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 GOBIVAZ

• 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 the refrigerator (2 °C-8 °C). Do not freeze.
• Keep the pre-filled pen in its 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. Contents of the pack and other information

What GOBIVAZ contains
The active substance is golimumab. One pre-filled pen containing 1 mL contains 100 mg of golimumab.
The other components are sorbitol, histidine, monohydrate histidine hydrochloride, polysorbate 80 and water for
injections. For further information about sorbitol, see section 2.
Description of the appearance of GOBIVAZ and contents of the pack
GOBIVAZ is supplied as an injectable solution in a single-use pre-filled pen. GOBIVAZ is available in packs containing 1 pre-filled pen and multipacks containing 3 (3 packs of 1) pre-filled pens. It is possible that not all pack sizes will 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 GOBIVAZ if the solution has changed colour, is cloudy, or contains visible foreign particles.
Marketing Authorisation Holder
Advanz Pharma Limited
Unit 17 Northwood House
Northwood Crescent
Dublin 9
D09 V504
Ireland
Manufacturer
Alvotech Hf
Sæmundargata 15-19
Reykjavik, 102
Iceland
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 GOBIVAZ, 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 looks like.

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 just 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 100 mg, you will use one 100 mg pre-filled pen.
  • If your dose is 200 mg, you will use two 100 mg pre-filled 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 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 blister pack

• Check the security seal on the blister pack lid.
• Do not use the pre-filled pen if the blister pack is damaged. 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 its box for 30 minutes, out of the reach of children.
• Do not heat the pre-filled pen in any other way (for example, do not heat it in a microwave or in warm 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 swab, 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 the liquid in the pre-filled pen 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.
• 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 middle front area 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 dose, administer the injections at different injection sites.

• Injectable areas

Figure 2

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

Washing hands and cleaning 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 Medicinal Product

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

Remove the cap (Figure 3)

• When you are ready for injection, 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.

Figure 3
Prepare to press the pre-filled pen against the skin (see Figure 4)

Figure 4

• Pinch the skin with your other hand. Prepare to place the pre-filled pen at the injection site so that the orange needle safety shield is directed toward the injection site.
• Hold the pen so that you can see the viewing window.

Press to inject (see Figure 5)

Figure 5

• Press the open end of the pre-filled pen firmly against the skin at a 90-degree angle.
• Wait for the first “click,” which indicates the start of the injection. You may or may not feel the needle entering the skin.
• Begin counting to 15 to ensure that all of the medicine is injected.

Do not lift the pre-filled pen from the skin. If you lift the pre-filled pen from the skin prematurely,
you may not have injected the full dose of the medicine.
Continue pressing until the orange indicator stops moving or until you hear the second “click”
(see Figure 6). It may take up to 15 seconds to hear the second “click” (which indicates that the
injection is complete and the needle has retracted into the pre-filled pen).

Figure 6

• Note: If you do not hear the second “click,” wait 15 seconds from the moment you first pressed the pre-filled pen, then remove the autoinjector from the injection site.

Check the viewing window – an orange indicator confirms successful administration
(see Figure 7)

• The orange indicator will completely cover the viewing window.
• Remove the pre-filled pen from the injection site.
• Speak with your doctor or pharmacist if the yellow indicator is not visible in the viewing window or if you suspect that you may not have received a complete dose. Do not administer a second dose without first discussing it with your doctor.

Figure 7

4. After the injection

Use a cotton ball or gauze

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

Dispose of the pre-filled pen (see Figure 8)

• Immediately place the pen into a sharps 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.

Figure 8

Package leaflet: information for the user

GOBIVAZ 100 mg solution for injection in pre-filled syringe

golimumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine as 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 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, consult your doctor, pharmacist or nurse. See section 4.

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

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

1. What GOBIVAZ is and what it is used for

GOBIVAZ contains an active substance called golimumab.
GOBIVAZ 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

GOBIVAZ 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 can be reduced.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease affecting 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 GOBIVAZ in combination with another medicine called methotrexate to:

• Reduce the signs and symptoms of the disease.
• Slow down joint and bone damage.
• Improve physical function.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis, an inflammatory skin condition. 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 GOBIVAZ to:

• Reduce the signs and symptoms of the disease.
• Slow down joint and bone damage.
• 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 GOBIVAZ to:

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

Ulcerative colitis
Ulcerative colitis is an inflammatory bowel disease. If you have ulcerative colitis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you will be given GOBIVAZ to treat your condition.

2. What you need to know before using GOBIVAZ

Do not use GOBIVAZ

• 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 GOBIVAZ.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GOBIVAZ.
Infections
Inform your doctor immediately if you have had or develop symptoms of infection during or after treatment with GOBIVAZ. 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 GOBIVAZ.
• Infections may progress more quickly and be more severe. In addition, past infections may reappear.

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 GOBIVAZ, 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 by your doctor on the Patient Reminder 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 thinks you are at risk of TB, you may be treated with medicines for TB before you are given GOBIVAZ.

Hepatitis B virus (HBV)

• Inform your doctor if you are a carrier of or have or have had hepatitis B before you are given GOBIVAZ.
• 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 GOBIVAZ may cause reactivation of the hepatitis B virus in patients carrying 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.
Cancer and lymphoma
Inform your doctor if you have or have ever had lymphoma (a type of blood cancer) or other types of cancer before you are given GOBIVAZ.

• If you use GOBIVAZ 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 this disease for a long time may have a higher than average risk of developing lymphoma.
• In children and adolescent patients treated with TNF-blocking medicines, cases of cancer, including unusual types, sometimes fatal, have been reported.
• 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 GOBIVAZ.
• Patients with severe persistent asthma, chronic obstructive pulmonary disease (COPD), or habitual smokers may have an increased risk of cancer with treatment with GOBIVAZ. 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 congestive heart failure or worsening of pre-existing heart failure have been reported with TNF blockers, including GOBIVAZ. Some of these patients have died.
• If you have mild heart failure and are treated with GOBIVAZ, 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 you should be given GOBIVAZ.
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 GOBIVAZ, by showing them the Patient Reminder 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 the body 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 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 GOBIVAZ.
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 GOBIVAZ.
• Some vaccinations may cause infections. If you received GOBIVAZ while pregnant, 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 GOBIVAZ 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 GOBIVAZ. 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, 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 administration of GOBIVAZ.

Children and adolescents
GOBIVAZ 100 mg is not recommended for the treatment of children and adolescents (under 18 years of age).
Other medicines and GOBIVAZ

• 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 GOBIVAZ 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) while using GOBIVAZ.

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

• You are pregnant or planning a pregnancy during treatment with GOBIVAZ. Limited information is available on the effects of this medicine in pregnant women. If you need to be treated with GOBIVAZ, you should avoid pregnancy by using an adequate method of contraception during treatment and for at least 6 months after the last injection of GOBIVAZ. GOBIVAZ should be used during pregnancy only if strictly necessary for you.
• Breastfeeding should be delayed until at least 6 months after the last treatment with GOBIVAZ. You must stop breastfeeding if you are to be given GOBIVAZ.
• If you received GOBIVAZ 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 GOBIVAZ before the baby receives any vaccine (for more information see the section on vaccinations). If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
GOBIVAZ has a minor influence on the ability to drive and use machines. However, dizziness may occur after using GOBIVAZ. In this case, do not drive or operate tools or machinery.
GOBIVAZ contains sorbitol
Sorbitol intolerance
This medicine contains 41 mg of sorbitol in each pre-filled syringe.

3. How to use GOBIVAZ

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

• The table below shows how you will generally use this medicine.

How GOBIVAZ is administered

• GOBIVAZ is administered by injection under the skin (subcutaneously).
• Initially, your doctor or nurse will inject GOBIVAZ for you. However, you and your doctor may decide that you can self-inject GOBIVAZ. In this case, you will be instructed on how to inject GOBIVAZ. 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 GOBIVAZ than you should
If you have used or have been given too much GOBIVAZ (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 GOBIVAZ
If you forget to use GOBIVAZ 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 GOBIVAZ
If you are considering stopping treatment with GOBIVAZ, speak to your doctor or pharmacist first.
If you have any doubts 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 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 GOBIVAZ, which include:

• 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 GOBIVAZ.
• 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, 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 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.

Tell your doctor immediately if you notice any of the symptoms listed above.
The following additional side effects have been observed with GOBIVAZ:
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), 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
• Cold sores (herpes labialis)
• 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 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 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 affecting the lungs, skin and lymph nodes (very commonly presenting as sarcoidosis)
• Pain and discoloration 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 get any side effects, including ones 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 GOBIVAZ

• 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-store this medicine in the refrigerator once it has reached room temperature. Dispose of this medicine if not used before the new expiry date or 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 in use. This will help protect the environment.

6. Package contents and other information

What GOBIVAZ contains
The active substance is golimumab. One 1 mL pre-filled syringe contains 100 mg of golimumab.
The other ingredients are sorbitol, histidine, histidine monohydrochloride monohydrate, poloxamer 188, and
water for injections. For more information on sorbitol, see section 2.
Description of the appearance of GOBIVAZ and contents of the pack
GOBIVAZ is supplied as an injectable solution in a single-use pre-filled syringe. GOBIVAZ 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 GOBIVAZ if the solution has changed colour, is cloudy, or contains visible foreign particles.
Marketing Authorisation Holder
Advanz Pharma Limited
Unit 17 Northwood House
Northwood Crescent
Dublin 9
D09 V504
Ireland
Manufacturer
Alvotech Hf
Sæmundargata 15-19
Reykjavik, 102
Iceland
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 GOBIVAZ, 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.

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 or by the needle protective cap.
• Never pull back the plunger.
• Never shake the prefilled syringe.
• Do not remove the needle protective cap from the prefilled syringe until instructed to do so.

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 will need to 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 carton and on the blister pack.
• Check the expiration date (indicated by “Exp.”) on the label on the barrel of the prefilled syringe.
• 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.

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 heat the prefilled syringe in any other way (for example, do not heat it in a microwave oven or in hot water). Do not remove the needle protective 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 wipe, 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.
• Observe the liquid through the inspection window of the prefilled syringe and make sure it is from clear to slightly opalescent (pearly appearance) and from 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 protective 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. Choosing and preparing 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 part of the abdomen (abdominal area) 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.

Figure 3
Selection of injection site when the caregiver is administering the injection (see Figure 4)

• If the injection is to be given 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.

Figure 4
Preparing 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 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 you are ready to inject, hold the pre-filled syringe body in one hand.
• Pull the needle protective cap straight off and dispose of it after the 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 letting it come into 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.

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 area of skin. Hold the syringe firmly. Never pull back on the plunger.

Injecting the medicine

• Insert the needle at an angle of approximately 45 degrees to the pinched skin. In one quick, smooth motion, insert the needle through the skin until it stops (see Figure 6).

Figure 6

• Release the skin and reposition your hand. Use your free hand to hold the body of the pre-filled syringe. Place the thumb of your other hand on the plunger and press it down completely until it stops (see Figure 7).

Figure 7

• Stop applying pressure to the plunger; the automatic safety shield will cover and lock the needle, then remove the needle from the skin (see Figure 8).

Figure 8

4. After the injection

Use a cotton ball or gauze

• A small amount of blood or liquid at the injection site may occur. This is normal.
• You may press a cotton ball or gauze over 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 9)

• Immediately place the prefilled syringe into 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 safety and the safety of others.

If you think something did not go right with the injection, or if you are unsure, talk to your
doctor or pharmacist.

Figure 9