GOBIVAZ 50 mg solution for injection in pre-filled pen

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Your doctor will also give you a Patient Reminder Card, which contains important safety information you need to be aware of before and during your treatment with GOBIVAZ.

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

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

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

Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin. If you have active psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines, you may be given GOBIVAZ to:

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

Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory diseases of the spine. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be given other medicines. If you do not respond well enough to these medicines, you may be given GOBIVAZ to:

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

Ulcerative colitis is an inflammatory disease of the bowel. If you have ulcerative colitis you will first be given other medicines. If you do not respond well enough to these medicines, you will be given GOBIVAZ to treat your disease.

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

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

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using GOBIVAZ.

Talk to your doctor, pharmacist or nurse before using GOBIVAZ

Infections

Tell your doctor straight away if you already have or get any symptoms of infection, during or after your treatment with GOBIVAZ. Symptoms of infection include fever, cough, shortness of breath, flu-like symptoms, diarrhoea, wounds, dental problems or a burning feeling when urinating.

• You may get infections more easily while using GOBIVAZ.
• Infections may progress more rapidly and may be more severe. In addition, some previous infections may reappear.

Tuberculosis (TB)

Tell your doctor straight away if symptoms of TB appear during or after your treatment.

Symptoms of TB include persistent cough, weight loss, tiredness, fever or night sweats.

Cases of TB have been reported in patients treated with GOBIVAZ, in rare occasions even in patients who have been treated with medicines for TB. Your doctor will test you to see if you have TB. Your doctor will record these tests on your Patient Reminder Card.

• It is very important that you tell your doctor if you have ever had TB, or if you have been in close contact with someone who has had or has TB.
• If your doctor feels that you are at risk of TB, you may be treated with medicines for TB before you begin using GOBIVAZ.

Hepatitis B virus (HBV)

• Tell your doctor if you are a carrier or if you have or have had HBV before you are given GOBIVAZ.
• Tell your doctor if you think you might be at risk of contracting HBV.
• Your doctor should test you for HBV.
• Treatment with TNF blockers such as GOBIVAZ may result in reactivation of HBV in patients who carry this virus, which can be life-threatening in some cases.

Invasive fungal infections

If you have lived in or travelled to an area where infections caused by specific type of fungi that can affect the lungs or other parts of the body (called histoplasmosis, coccidioidomycosis, or blastomycosis), are common, tell your doctor straight away. Ask your doctor if you don’t know if these fungal infections are common in the area in which you have lived or travelled.

Cancer and lymphoma

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

• If you use GOBIVAZ or other TNF blockers, your risk for developing lymphoma or another cancer may increase.
• Patients with severe rheumatoid arthritis and other inflammatory diseases, who have had the disease for a long time, may be at higher than average risk of developing lymphoma.
• There have been cases of cancers, including unusual types, in children and teenage patients taking TNF-blocking agents, which sometimes resulted in death.
• On rare occasions, a specific and severe 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 resulted in death. Almost all of these patients had also received medicines known as azathioprine or 6-mercaptopurine.
  Tell your doctor if you are taking azathioprine or 6-mercaptopurine with GOBIVAZ.
• Patients with severe persistent asthma, chronic obstructive pulmonary disease (COPD), or are heavy smokers may be at increased risk for cancer with GOBIVAZ treatment. If you have severe persistent asthma, COPD or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.
• Some patients treated with golimumab have developed certain kinds of skin cancer. If any changes in the appearance of the skin or growths on the skin occur during or after therapy, tell your doctor.

Heart failure

Tell your doctor straight away if you get new or worsening symptoms of heart failure. Symptoms of heart failure include shortness of breath or swelling of your feet.

• New and worsening congestive heart failure has been reported with TNF blockers, including GOBIVAZ. Some of these patients died.
• If you have mild heart failure and you are being treated with GOBIVAZ, you must be closely monitored by your doctor.

Nervous system disease

Tell your doctor straight away if you have ever been diagnosed with or develop symptoms of a demyelinating disease such as multiple sclerosis. Symptoms may include changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body. Your doctor will decide if you should receive GOBIVAZ.

Operations or dental procedures

• Talk to your doctor if you are going to have any operations or dental procedures.
• Tell your surgeon or dentist performing the procedure that you are having treatment with GOBIVAZ by showing them your Patient Reminder Card.

Autoimmune disease

Tell your doctor if you develop symptoms of a disease called lupus. Symptoms include persistent rash, fever, joint pain and tiredness.

• On rare occasions, people treated with TNF blockers have developed lupus.

Blood disease

In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding. If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may decide to stop treatment.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using GOBIVAZ.

Vaccinations

Talk to your doctor if you have had, or are due to have a vaccine.

• You should not receive certain (live) vaccines while using GOBIVAZ.
• Certain vaccinations may cause infections. If you received GOBIVAZ while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately six months after the last dose you received during pregnancy. It is important that you tell your baby's doctors and other health care professionals about your GOBIVAZ use so they can decide when your baby should receive any vaccine.

Talk to your child’s doctor regarding 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 received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer).

Allergic reactions

Tell your doctor straight away if you develop symptoms of an allergic reaction after your treatment with GOBIVAZ. Symptoms of an allergic reaction may include swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing, skin rash, hives, swelling of the hands, feet or ankles.

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

GOBIVAZ is not recommended for children less than 2 years of age with polyarticular juvenile idiopathic arthritis because it has not been studied in this group.

• Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including any other medicines to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
• You should not take GOBIVAZ with medicines containing the active substance anakinra or abatacept. These medicines are used for the treatment of rheumatic diseases.
• Tell your doctor or pharmacist if you are taking any other medicines that affect your immune system.
• You should not receive certain (live) vaccines while using GOBIVAZ.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using GOBIVAZ.

Talk to your doctor before using GOBIVAZ if:

• You are pregnant or are planning to become pregnant while using GOBIVAZ. There is limited information about the effects of this medicine in pregnant women. If you are being treated with GOBIVAZ, you must avoid becoming pregnant by using adequate contraception during your treatment and for at least 6 months after the last GOBIVAZ injection. GOBIVAZ should only be used during pregnancy if it is clearly necessary for you.
• Before starting breast-feeding, your last treatment with GOBIVAZ must be at least 6 months ago.
  You must stop breast-feeding if you are to be given GOBIVAZ.
• If you received GOBIVAZ during your pregnancy, your baby may have a higher risk for getting an infection. It is important that you tell your baby’s doctors and other health care professionals about your GOBIVAZ use before the baby receives any vaccine (for more information see section on vaccination).

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

GOBIVAZ has minor influence on your ability to drive and use tools or machines. Dizziness may however occur after you take GOBIVAZ. If this happens, do not drive or use any tools or machines.

Sorbitol intolerance

This medicine contains 20.5 mg sorbitol in each pre-filled pen.

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) given once a month, on the same date each month.
• Talk to your doctor before taking your fourth dose. Your doctor will determine if you should continue GOBIVAZ treatment.
  • If you weigh more than 100 kg, the dose might be increased to 100 mg (the content of 2 pre-filled pens) given once a month, on the same date each month.

Polyarticular juvenile idiopathic arthritis in children 2 years of age and older:

• For patients weighing at least 40 kg, the recommended dose is 50 mg given once a month, on the same date each month.
• Talk to your doctor before you take the fourth dose. Your doctor will determine if you should continue GOBIVAZ treatment.

Ulcerative colitis

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

Initial treatment

A starting dose of 200 mg (the contents of 4 pre-filled pens) followed by 100 mg (the contents of 2 pre-filled pens) 2 weeks later.

Maintenance treatment

• In patients weighing less than 80 kg, 50 mg (the contents of 1 pre-filled pen) 4 weeks after your last treatment, then every 4 weeks thereafter. Your doctor may decide to prescribe 100 mg (the contents of 2 pre-filled pens), depending on how well GOBIVAZ works for you.
• In patients weighing 80 kg or more, 100 mg (the contents of 2 pre-filled pens) 4 weeks after your last treatment, then every 4 weeks thereafter.

• GOBIVAZ is given by injection under the skin (subcutaneously).
• At the start, your doctor or nurse may inject GOBIVAZ. However, you and your doctor may decide that you may inject GOBIVAZ yourself. In this case you will get training on how to inject GOBIVAZ yourself.

Talk to your doctor if you have any questions about giving yourself an injection. You will find detailed “Instructions for Use” at the end of this leaflet.

If you have used or been given too much GOBIVAZ (either by injecting too much on a single occasion, or by using it too often), talk to your doctor or pharmacist straight away. Always take the outer carton and this leaflet with you, even if it is empty.

If you forget to use GOBIVAZ on your planned date, inject the forgotten dose as soon as you remember.

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

When to inject your next dose:

• If you are less than 2 weeks late, inject the forgotten dose as soon as you remember and stay on your original schedule.
• If you are more than 2 weeks late, inject the forgotten dose as soon as you remember and talk to your doctor or pharmacist to ask when you need to take the next dose.

If you are not sure what to do, talk to your doctor or pharmacist.

If you are considering stopping GOBIVAZ, talk to your doctor or pharmacist first.

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

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

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

• Abnormal liver tests (increased liver enzymes) found during blood tests done by your doctor
• Feeling dizzy
• Headache
• Feeling numb or having a tingling feeling
• Superficial fungal infections
• Abscess
• Bacterial infections (such as cellulitis)
• Low red blood cell counts
• Low white blood cell counts
• Positive blood lupus test
• Allergic reactions
• Indigestion
• Stomach pain
• Feeling sick (nausea)
• Flu
• Bronchitis
• Sinus infection
• Cold sores
• High blood pressure
• Fever
• Asthma, shortness of breath, wheezing
• Stomach and bowel disorders which include inflammation of the stomach lining and colon which may cause fever
• Pain and ulcers in the mouth
• Injection site reactions (including redness, hardness, pain, bruising, itching, tingling and
• irritation)
• Hair loss
• Rash and itching of the skin
• Difficulty sleeping
• Depression
• Feeling weak
• Bone fractures
• Chest discomfort

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

• Kidney infection
• Cancers, including skin cancer and non-cancerous growths or lumps, including skin moles
• Skin blisters
• Severe infection throughout the body (sepsis), sometimes including low blood pressure (septic shock)
• Psoriasis (including on the palms of your hand and/or the soles of your feet and/or in the form of skin blisters)
• Low platelet count
• Combined low platelet, red, and white blood cell count
• Thyroid disorders
• Increase in blood sugar levels
• Increase in blood cholesterol levels
• Balance disorders
• Vision disturbances
• Inflamed eye (conjunctivitis)
• Eye allergy
• Sensation of heart beating irregularly
• Narrowing of the blood vessels in the heart
• Blood clots
• Flushing
• Constipation
• Chronic inflammatory condition of the lungs
• Acid reflux
• Gall stones
• 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
• Severely decreased number of white blood cells
• Infection of the joints or the tissue around them
• Impaired healing
• Inflammation of blood vessels in internal organs
• Leukaemia
• Melanoma (a type of skin cancer)
• Merkel cell carcinoma (a type of skin cancer)
• Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes)
• Scaly, peeling skin
• Immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
• Pain and discolouration in the fingers or toes
• Taste disturbances
• Bladder disorders
• Kidney disorders
• Inflammation of the blood vessels in your skin which results in rash

Side effects of which the frequency is not known:

• A rare blood cancer affecting mostly young people (hepatosplenic T-cell lymphoma)
• Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin
• Worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is golimumab. One 0.5 mL pre-filled pen contains 50 mg of golimumab.

The other ingredients are sorbitol, L-histidine, L-histidine monohydrochloride monohydrate, poloxamer 188 and water for injections. For more information on sorbitol, see Section 2.

GOBIVAZ is supplied as solution for injection 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. Not all pack sizes may be marketed.

The solution is clear to slightly opalescent (having a pearl-like shine), colourless to light yellow and may contain a few small translucent or white particles of protein. Do not use GOBIVAZ if the solution is discoloured, cloudy or you can see foreign particles in it.

• Do not shake the pre-filled pen at any time.
• Do not remove the cap from the pre-filled pen until immediately before the injection.
• Do not put the cap of the pre-filled pen back on if removed to avoid bending the needle.

Check the number of pre-filled pens

Check the pre-filled pens to make sure

• the number of pre-filled pens and strength is correct
  • If your dose is 50 mg, you will get one 50 mg pre-filled pen
  • If your dose is 100 mg, you will get two 50 mg pre-filled pens and you will need to give yourself two injections. Choose two different sites for these injections (e.g. one injection in the right thigh and the other injection in the left thigh) and give the injections one right after the other.
  • If your dose is 200 mg, you will get four 50 mg pre-filled pens and you will need to give yourself four injections. Choose different sites for these injections and give the injections one right after the other.

Check expiry date

• Check the expiration date printed or written on the carton.
• Check the expiration date (as indicated as “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. Please contact your doctor or pharmacist for assistance.

Check the blister

• Check the sealed security lid on the blister.
• Do not use if the blister is broken. Please contact your doctor or pharmacist.

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

• To ensure proper injection, allow the pre-filled pen to sit 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 pre-filled pen’s cap while allowing it to reach room temperature.

Get the rest of your equipment ready

• While you are waiting you can get the rest of your equipment ready, 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 to make sure that the liquid in the pre-filled pen is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow. The solution can be used if it contains a few small translucent or white particles of protein.
• You will also notice an air bubble, which is normal.
• Do not use the pre-filled pen if the liquid is the wrong colour, cloudy, or contains larger particles. If this happens, talk to your doctor or pharmacist.

• You can inject the medicine into the front of the middle thighs.
• You can use the stomach (abdomen) below the belly button, except for approximately the 5 cm area directly underneath the belly button.
• Do not inject into areas where the skin is tender, bruised, red, scaly, hard or has scars or stretch marks.
• If multiple injections are required for a single administration, the injections should be administered at different injection sites.

DO NOT inject into the arm to avoid failure of the pre-filled pen and/or unintentional injury.

Wash hands and clean the injection site

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

• The cap should not be removed until you are ready to inject the medicine.
• The medicine should be injected within 5 minutes after the cap has been removed.

Remove the cap (figure 3)

• When you are ready to inject, pull the cap off and throw it away after your injection.
• Do not put the cap back on because it may damage the needle inside the pre-filled pen.
• Do not use the pre-filled pen if it is dropped without the cap in place. If this happens please contact your doctor or pharmacist.

Prepare to push the pre-filled pen against the skin (see figure 4).

• Pinch the skin with other hand. Prepare to position the pre-filled pen over the injection site so that the orange needle shield points toward the injection site.
• Hold the pen so that you can see the inspection window.

Push to inject (see figure 5).

• Push the open end of the pre-filled pen against the skin at a 90-degree angle (see Figure 5).
• Wait for the first “click” that signals the start of injection. You may or may not feel a needle prick.
• Start counting to 15 to ensure that all drug gets injected.

Do not lift the pre-filled pen away from your skin. If you pull the pre-filled pen away from your skin, you may not get your full dose of medicine.

Continue to hold until the orange indicator has stopped moving or you hear the second ‘click’ (see figure 6). It can take up to 15 seconds for you to hear the second ‘click’ sound (indicating that the injection has finished and the needle has gone back into the pre-filled pen).

• Note: If you do not hear the second ‘click’, wait 15 seconds from the time you first press the pre-filled pen against the skin and then lift the autoinjector from the injection site.

Check the viewing window – an orange indicator confirms proper administration (see figure 7)

• The orange indicator will completely fill in the viewing window.
• Lift the pre-filled pen from the injection site.
• Talk to your doctor or pharmacist if the orange indicator is not visible in the window or if you suspect that you may not have received a complete dose. Do not administer a second dose without speaking to your doctor.

Use a cotton ball or gauze

• There may be a small amount of blood or liquid at the injection site. This is normal.
• You can 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 necessary.
• Do not rub your skin.

Throw the pre-filled pen away (see figure 8)

• Place your pen in a sharps container straight away. Make sure you dispose of the bin as instructed by your doctor or nurse when the container is full.

If you feel that something has gone wrong with the injection or if you are not sure, talk to your doctor or pharmacist.