Gobivaz 50 mg solution for injection in Pre-filled syringe – patient leaflet, side effects, dosage

1. W

GOBIVAZ contains the active substanc GOBIVAZ belongs to a group of medic following inflammatory diseases:

• Rheumatoid arthritis
• Psoriatic arthritis
• Axial spondyloarthritis, including an
• Ulcerative colitis

In children 2 years of age and older, G GOBIVAZ works by blocking the action involved in inflammatory processes of t

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory given other medicines. If you do not re you will take in combination with anoth

• Reduce the signs and symptoms of
• Slow down the damage to your bon
• Improve your physical function

Psoriatic arthritis

Psoriatic arthritis is an inflammatory dis disease of the skin. If you have active p well enough to these medicines, you m

• Reduce the signs and symptoms of
• Slow down the damage to your bon
• Improve your physical function

Ankylosing spondylitis and non-radi

Ankylosing spondylitis and non-radiog have ankylosing spondylitis or non-rad you do not respond well enough to the

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

Ulcerative colitis

Ulcerative colitis is an inflammatory dis medicines. If you do not respond well

Polyarticular juvenile idiopathic arthr

Polyarticular juvenile idiopathic arthritis you have polyarticular juvenile idiopath enough to these medicines, you will be

2. What

Do not use GOBIVAZ

• If you are allergic (hypersensitive) to

  Section 6).

• If you have tuberculosis (TB) or any
• If you have moderate or severe hear If you are not sure if any of the above a GOBIVAZ.

Warnings and precautions

Talk to your doctor, pharmacist or nurs

Infections

Tell your doctor straight away if you alr with GOBIVAZ. Symptoms of infection wounds, dental problems or a burning

• You may get infections more easily

• Infections may progress more rapid

  reappear.

Tuberculosis (TB)

Tell your doctor straight away if sympto Symptoms of TB include persistent co

• Cases of TB have been reported in

  been treated with medicines for TB. tests on your Patient Reminder Card

• It is very important that you tell your

  someone who has had or has TB.

• If your doctor feels that you are at ri

  GOBIVAZ.

Hepatitis B virus (HBV)

• Tell your doctor if you are a carrier o Tell your doctor if you think you mig
• Your doctor should test you for HBV

• Treatment with TNF blockers such a

  which can be life-threatening in som

Invasive fungal infections

If you have lived in or travelled to an ar or other parts of the body (called histo doctor straight away. Ask your doctor i you have lived or travelled.

Cancer and lymphoma

Tell your doctor if you have ever been before you use GOBIVAZ.

• If you use GOBIVAZ or other TNF bl

• Patients with severe rheumatoid arth

  time, may be at higher than average

• There have been cases of cancers,

  TNF-blocking agents, which someti

INSTRUCTIONS FOR USE

If you would like to self inject GOBIV injection and give it to yourself. If yo pharmacist to schedule a training se

In these instructions:

1. 1. Preparing for use of the pre-filled sy
2. 2. Choosing and preparing the injectio
3. 3. Injecting the medicine
4. 4. After the injection

The diagram below (see figure 1) show

1. 1. Preparing for use of the pre-filled Hold the pre-filled syringe by the bo
2. • Do not hold by the plunger, or need
3. • Do not pull back on the plunger at a
4. • Do not shake the pre-filled syringe a
5. • Do not remove the needle cover fro

Check the number of pre-filled syrin

Check the pre-filled syringes to make s

• the number of pre-filled syringes an

  o If your dose is 50 mg, you will ge

  o If your dose is 100 mg, you will g

  injections. Choose two different s injection in the left thigh), and giv

  o If your dose is 200 mg, you will g

  injections. Choose different sites

Check expiry date (see figure 2)

• Check the expiration date printed or
• Check the expiration date (as indica

• Do not use the pre-filled syringe if th

  day of the month. Please contact yo

  l monitoring. This will allow quick identific cts you may get. See the end of section 4

  e you start using this medicine becaus

  ead it again.

  k your doctor, pharmacist or nurse. for you only. Do not pass it on to others. I rs.

  ur doctor, or pharmacist or nurse. This inc

  Reminder Card, which contains importan ent with GOBIVAZ.

  d for

  use GOBIVAZ

  mation

  GOBIVAZ

  ation of new safety information. for how to report side effects.

  e it contains important

  t may harm them, even if their

  ludes any possible side effects not

  t safety information you need to be

  ults for the treatment of the

  axial spondyloarthritis

  rticular juvenile idiopathic arthritis. r alpha’ (TNF-α). This protein is nflammation in your body.

  heumatoid arthritis you will first be ou may be given GOBIVAZ which

  y psoriasis, an inflammatory er medicines. If you do not respond

  tory diseases of the spine. If you first be given other medicines. If Z to:

  olitis you will first be given other ven GOBIVAZ to treat your disease.

  int pain and swelling in children. If dicines. If you do not respond well hotrexate to treat the disease.

  IVAZ

  ts of this medicine (listed in

  cist or nurse before using

  on, during or after your treatment flu-like symptoms, diarrhoea,

  ome previous infections may

  tment.

  sweats.

  asions even in patients who have e TB. Your doctor will record these

  have been in close contact with

  es for TB before you begin using

  are given GOBIVAZ.

  BV in patients who carry this virus,

  pe of fungi that can affect the lungs mycosis), are common, tell your are common in the area in which

  d cancer) or any other cancer

  a or another cancer may increase.

  o have had the disease for a long

  eenage patients taking

  Package leaflet: Infor ® 50 mg solution for

  golimu

  hat GOBIVAZ is and what it is used for

  e called golimumab.

  ines called ‘TNF blockers’. It is used in ad

  kylosing spondylitis and non-radiographic

  OBIVAZ is used for the treatment of polya of a protein called ‘tumour necrosis facto he body, and blocking it can reduce the i

  disease of the joints. If you have active r spond well enough to these medicines, y er medicine called methotrexate to: your disease.

  es and joints.

  ease of the joints, usually accompanied b soriatic arthritis you will first be given oth ay be given GOBIVAZ to:

  your disease.

  es and joints.

  ographic axial spondyloarthritis

  raphic axial spondyloarthritis are inflamma iographic axial spondyloarthritis, you will se medicines, you may be given GOBIVA your disease.

  ease of the bowel. If you have ulcerative c enough to these medicines, you will be gi

  itis

  is an inflammatory disease that causes jo ic arthritis you will first be given other me given GOBIVAZ in combination with met

  you need to know before you use GOB

  golimumab or any of the other ingredien

  other severe infection.

  t failure.

  pplies to you, talk to your doctor, pharma

  e before using GOBIVAZ

  eady have or get any symptoms of infecti include fever, cough, shortness of breath, feeling when urinating.

  while using GOBIVAZ.

  ly and may be more severe. In addition, s

  ms of TB appear during or after your trea ugh, weight loss, tiredness, fever or night patients treated with GOBIVAZ, in rare occ Your doctor will test you to see if you hav .

  doctor if you have ever had TB, or if you

  sk of TB, you may be treated with medicin

  r if you have or have had HBV before you ht be at risk of contracting HBV. .

  s GOBIVAZ may result in reactivation of H e cases.

  ea where infections caused by specific ty plasmosis, coccidioidomycosis, or blasto f you don’t know if these fungal infections

  diagnosed with lymphoma (a type of bloo

  ockers, your risk for developing lymphom ritis and other inflammatory diseases, wh risk of developing lymphoma.

  including unusual types, in children and t mes resulted in death.

  • On rare occasions, a specific and se

    observed in patients taking other TN This type of cancer has usually resu known as azathioprine or 6-mercapt with GOBIVAZ.

  • Patients with severe persistent asth

    may be at increased risk for cancer a heavy smoker, you should discuss you.

  • Some patients treated with golimum

    appearance of the skin or growths o

Heart failure

Tell your doctor straight away if you ge include shortness of breath or swelling

• New and worsening congestive hea

  these patients died.

• If you have mild heart failure and yo

  doctor.

Nervous system disease

Tell your doctor straight away if you ha disease such as multiple sclerosis. Sy or numbness or tingling in any part of y

Operations or dental procedures

• Talk to your doctor if you are going t

• Tell your surgeon or dentist perform

  them your Patient Reminder Card.

Autoimmune disease

Tell your doctor if you develop sympto pain and tiredness.

• On rare occasions, people treated w

Blood disease

In some patients the body may fail to p you to stop bleeding. If you develop a f your doctor right away. Your doctor ma If you are not sure if any of the above a

Vaccinations

Talk to your doctor if you have had, or

• You should not receive certain (live)

• Certain vaccinations may cause infe

  be at higher risk for getting such an during pregnancy. It is important tha GOBIVAZ use so they can decide w Talk to your child’s doctor regarding va vaccinations before using GOBIVAZ.

Therapeutic infectious agents Talk to your doctor if you have recently agent (such as BCG instillation used fo

Allergic reactions

Tell your doctor straight away if you de Symptoms of an allergic reaction may i in swallowing or breathing, skin rash, h

• Some of these reactions may be ser
• Some of these reactions occurred a

Children

GOBIVAZ is not recommended for chil because it has not been studied in this

Other medicines and GOBIVAZ

• Tell your doctor or pharmacist if you

  any other medicines to treat rheuma ankylosing spondylitis, non-radiogra

• You should not take GOBIVAZ with

  medicines are used for the treatmen

• Tell your doctor or pharmacist if you
• You should not receive certain (live) If you are not sure if any of the above a

Pregnancy and breast-feeding

Talk to your doctor before using GOBIV

• You are pregnant or are planning to

  the effects of this medicine in pregn becoming pregnant by using adequ last GOBIVAZ injection. GOBIVAZ s

• Before starting breast-feeding, your You must stop breast-feeding if you

• If you received GOBIVAZ during you

  important that you tell your baby’s d the baby receives any vaccine (for m If you are pregnant or breast-feeding, t or pharmacist for advice before taking

Driving and using machines

GOBIVAZ has minor influence on your after you take GOBIVAZ. If this happen

GOBIVAZ contains sorbitol

Sorbitol intolerance

This medicine contains 20.5 mg sorbit

Always use this medicine exactly as yo if you are not sure.

How much GOBIVAZ is given

Rheumatoid arthritis, psoriatic arthritis, non-radiographic axial spondyloarthriti

• The recommended dose is 50 mg (t

  each month.

• Talk to your doctor before taking yo

  treatment.

  o If you weigh more than 100 kg, th

  given once a month, on the same Polyarticular juvenile idiopathic arthritis

• For patients weighing at least 40 kg,

  each month.

• Talk to your doctor before you take t

  treatment.

Ulcerative colitis

• The table below shows how you will mation for the user

injection in pre-filled

mab

vere type of lymphoma called hepatosp F-blockers. Most of these patients were lted in death. Almost all of these patient opurine. Tell your doctor if you are takin ma, chronic obstructive pulmonary disea with GOBIVAZ treatment. If you have se with your doctor whether treatment wit ab have developed certain kinds of skin n the skin occur during or after therapy, t new or worsening symptoms of heart f of your feet.

rt failure has been reported with TNF blo u are being treated with GOBIVAZ, you ve ever been diagnosed with or develop mptoms may include changes in your vis our body. Your doctor will decide if you

o have any operations or dental proced ing the procedure that you are having tr ms of a disease called lupus. Symptoms ith TNF blockers have developed lupus roduce enough of the blood cells that h ever that does not go away, bruise or bl y decide to stop treatment.

pplies to you, talk to your doctor or pha are due to have a vaccine.

vaccines while using GOBIVAZ. ctions. If you received GOBIVAZ while y infection for up to approximately six mo t you tell your baby's doctors and other hen your baby should receive any vacci ccinations for your child. If possible, you received or are scheduled to receive tre r the treatment of cancer).

velop symptoms of an allergic reaction a nclude swelling of the face, lips, mouth ives, swelling of the hands, feet or ankle ious or, rarely, life-threatening. fter the first administration of GOBIVAZ dren less than 2 years of age with polyar group.

are using, have recently used or might toid arthritis, polyarticular juvenile idiop phic axial spondyloarthritis, or ulcerativ medicines containing the active substan t of rheumatic diseases.

are taking any other medicines that affe vaccines while using GOBIVAZ. pplies to you, talk to your doctor or pha

AZ if:

become pregnant while using GOBIVAZ ant women. If you are being treated with ate contraception during your treatment hould only be used during pregnancy if i last treatment with GOBIVAZ must be at are to be given GOBIVAZ.

r pregnancy, your baby may have a hig octors and other health care profession ore information see section on vaccinat hink you may be pregnant or are planni this medicine.

ability to drive and use tools or machine s, do not drive or use any tools or mach ol in each pre-filled syringe.

syringe

lenic T-cell lymphoma has been adolescent or young adult males. s had also received medicines g azathioprine or 6-mercaptopurine se (COPD), or are heavy smokers vere persistent asthma, COPD or are h a TNF blocker is appropriate for cancer. If any changes in the tell your doctor.

ailure. symptoms of heart failure ckers, including GOBIVAZ. Some of must be closely monitored by your symptoms of a demyelinating ion, weakness in your arms or legs should receive GOBIVAZ.

ures.

eatment with GOBIVAZ by showing include persistent rash, fever, joint

.

elp your body fight infections or help eed very easily or look very pale, call rmacist before using GOBIVAZ.

ou were pregnant, your baby may nths after the last dose you received health care professionals about your ne.

r child should be up to date with all atment with a therapeutic infectious fter your treatment with GOBIVAZ. or throat which may cause difficulty s.

ticular juvenile idiopathic arthritis use any other medicines, including athic arthritis, psoriatic arthritis, e colitis.

ce anakinra or abatacept. These ct your immune System.

rmacist before using GOBIVAZ.

. There is limited information about GOBIVAZ, you must avoid and for at least 6 months after the t is clearly necessary for you. least 6 months ago.

her risk for getting an infection. It is als about your GOBIVAZ use before ion).

ng to have a baby, ask your doctor s. Dizziness may however occur ines.

heck with your doctor or pharmacist kylosing spondylitis and once a month, on the same date e if you should continue GOBIVAZ he content of 2 pre-filled syringes)

once a month, on the same date ne if you should continue GOBIVAZ ture outside the box for 30 minutes, m it in a microwave or in hot water). room temperature.

g an alcohol swab, a cotton ball or nward.

ake sure that it is clear to slightly ution can be used if it contains a few yringe by its body and rotate the tains larger particles. If this happens, ept for approximately the 5 cm area has scars or stretch marks. hould be administered at different he upper arms.

1. 3. How to use GOBIVAZ ur doctor or pharmacist has told you. C and axial spondyloarthritis, including an s:

he content of 1 pre-filled syringe) given ur fourth dose. Your doctor will determin e dose might be increased to 100 mg (t date each month.

in children 2 years of age and older: the recommended dose is 50 mg given he fourth dose. Your doctor will determi usually use this medicine.

AZ, you must be trained by a healthcar u have not been trained, please contac ssion.

ringe

n site

s what the pre-filled syringe looks like.

e professional to prepare an t your doctor, nurse or

do so.

will need to give yourself two in the right thigh and the other

will need to give yourself four s one right after the other.

the pre-filled syringe.

expiration date refers to the last

Wait 30 minutes to allow pre-filled sy

• To ensure proper injection, allow the

  out of the reach of children.

• Do not warm the pre-filled syringe in
• Do not remove the pre-filled syringe

Get the rest of your equipment ready

• While you are waiting you can get th

  gauze and a sharps container.

Check the liquid in the pre-filled syri

• Hold the pre-filled syringe by its bod

• Look at the liquid through the viewin

  opalescent (having a pearl-like shin small translucent or white particles o

• If you cannot see the liquid through

  needle cover to line up the liquid to Do not use the pre-filled syringe if the li talk to your doctor or pharmacist.

• Choosing and preparing the inject
• You usually inject the medicine into

• You can also use the lower stomach

  directly underneath the belly button.

• Do not inject into areas where the sk

• If multiple injections are required for

  sites on the body.

Injection site selection for caregivers

• If a caregiver is giving you the inject
• Again, all sites mentioned can be us

Preparing injection site

• Wash your hands thoroughly with so
• Wipe the injection site with an alcoh

• Allow the skin to dry before injecting Do not touch this area again before giv

  ringe to reach room temperature pre-filled syringe to sit at room tempera any other way (for example, do not war ’s needle cover while allowing it to reach e rest of your equipment ready, includin nge

  y with the covered needle pointing dow g window of the pre-filled syringe and m

  1. e) and colourless to light yellow. The sol f protein.

the viewing window, hold the pre-filled s the viewing window (see figure 2). quid is the wrong colour, cloudy, or con ion site (see figure 3)

the front of the middle thighs.

(abdomen) below the belly button, exc in is tender, bruised, red, scaly, hard or a single administration, the injections s

Figure 3

(see figure 4)

ion, they can also use the outer area of t ed regardless of your body type or size.

Figure 4

ap and warm water.

ol swab.

. Do not fan or blow on the clean area. ing the injection.

Dimension: 420 x 891 mm Commodity No.: N/A

Initial treatment A starting dose of 200 mg (the contents of 4 pre-filled syringes)

followed by 100 mg (the contents of 2 pre-filled syringes) 2 weeks later.

Maintenance treatment • In patients weighing less than 80 kg, 50 mg (the contents of 1 pre-filled syringe) 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 syringes), depending on how well GOBIVAZ works for you.

• In patients weighing 80 kg or more, 100 mg (the contents of 2 pre-filled syringes) 4 weeks after your last treatment, then every 4 weeks thereafter.

How GOBIVAZ is given

• 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 use more GOBIVAZ than you should

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

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 stop using GOBIVAZ

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

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

Tell your doctor straight away if you notice any of the following serious side effects of GOBIVAZ which include:

• allergic reactions which may be serious, or rarely, life-threatening (rare). 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 occurred after the first administration of GOBIVAZ.

• serious infections (including TB, bacterial infections including serious blood infections and pneumonia,

  severe fungal infections and other opportunistic infections) (common). Symptoms of an infection can include fever, tiredness, (persistent) cough, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, dental problems and a burning feeling when urinating.

• reactivation of hepatitis B virus if you are a carrier or have had hepatitis B before (rare). Symptoms can

  include yellowing of the skin and eyes, dark brown-coloured urine, right-sided abdominal pain, fever, feeling sick, being sick, and feeling very tired.

• nervous system disease such as multiple sclerosis (rare). Symptoms of nervous system disease can include

  changes in your vision, weakness in your arms or legs, numbness or tingling in any part of your body.

• cancer of the lymph nodes (lymphoma) (rare). Symptoms of lymphoma can include swelling of the lymph

  nodes, weight loss, or fever.

• heart failure (rare). Symptoms of heart failure can include shortness of breath or swelling of your feet.

• signs of immune system disorders called:

  • lupus (rare). Symptoms can include joint pain or a rash on cheeks or arms that is sensitive to the sun.

  • sarcoidosis (rare). Symptoms can include a persistent cough, being short of breath, chest pain, fever,

    swelling of your lymph nodes, weight loss, skin rashes, and blurred vision.

• swelling of small blood vessels (vasculitis) (rare). Symptoms can include fever, headache, weight loss, night

  sweats, rash, and nerve problems such as numbness and tingling.

• skin cancer (uncommon). Symptoms of skin cancer can include changes in the appearance of your skin or

  growths on your skin.

• blood disease (common). Symptoms of blood disease can include a fever that does not go away, bruising or

  bleeding very easily or looking very pale.

• blood cancer (leukaemia) (rare). Symptoms of leukaemia can include fever, feeling tired, frequent infections,

  easy bruising, and night sweats.

Tell your doctor straight away if you notice any of the above symptoms.

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, 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).

Reporting of side effects

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.

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 syringe in the outer carton in order to protect it from light.
• This medicine can also be stored out of the refrigerator at temperatures up to a maximum of 25°C for a single period of up to 30 days, but not beyond the original expiry date printed on the carton. Write the new expiry date on the carton including day/month/year (no more than 30 days after the medicine is removed from the refrigerator). Do not return this medicine to refrigerator if it has reached room temperature. Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.
• Do not use this medicine if you notice that the liquid is not a clear to light yellow colour, cloudy, or contains foreign particles.
• Do not throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What GOBIVAZ contains

The active substance is golimumab. One 0.5 mL pre-filled syringe 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.

What GOBIVAZ looks like and contents of the pack

GOBIVAZ is supplied as solution for injection 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 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.

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

This leaflet was last revised in September 2025.

1. 3. Injecting the medicine

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

Do not touch the plunger during needle cover removal.

Remove the needle cover (see figure 5)

• When you are ready to inject, hold the body of the pre-filled syringe with one hand.

• Pull the needle cover straight off and throw it away after your injection. Do not touch the plunger while you do

  this.

• You may notice an air bubble in the pre-filled syringe or a drop of liquid at the end of the needle. These are both

  normal and do not need to be removed.

• Inject the dose promptly after removing the needle cover.

Do not touch the needle or allow it to touch any surface.

Do not use the pre-filled syringe if it is dropped without the needle cover in place. If this happens, please contact your doctor or pharmacist.

Figure 5

Position the pre-filled syringe to inject

• Hold the body of the pre-filled syringe with one hand between the middle and index fingers and place the thumb

  on top of the plunger head and use the other hand to gently pinch the area of skin that you previously cleaned. Hold firmly. Do not pull back on the plunger at any time.

Inject the medicine

• Place the needle at approximately a 45-degree angle to the pinched skin. In a single and swift motion, insert the

  needle through the skin as far as it will go (see figure 6).

  Figure 6

  • Release pinch and reposition hand. Use your free hand to grasp the body of the pre-filled syringe. Place thumb from the opposite hand on the plunger and press the plunger all the way down until it stops. (see figure 7).

    Figure 7

  • Release pressure from plunger, the safety guard will cover the needle and lock into place, removing the needle from your skin (see figure 8).

    Figure 8

  • 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 can press a cotton ball or gauze over the injection site and hold 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 syringe away (see figure 10)

• Place your pre-filled syringe in a sharps container straight away. Make sure you dispose of the bin as instructed by your doctor or nurse.

Do not attempt to recap the needle.

Do not ever re-use a pre-filled syringe, for your safety and health and for the safety of others. If you feel that something has gone wrong with the injection or if you are not sure, talk to your doctor or pharmacist.

Figure 9

AW-LF-0001384 (v0.9) 45°

90°

Dimension: 420 x 891 mm Commodity No.: N/A

GOBIVAZ Patient Reminder Card

This Patient Reminder Card contains important safety information that you need to be aware of before and during treatment with GOBIVAZ. Show this card to any doctor involved in your treatment.

1. 1. Infections

When you are treated with GOBIVAZ, you might

severe infection.

• You should be screened for TB. 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 TB. Ask your doctor to record the type and date of the last screening(s) for TB below:

Test __________________________________

____________________Date_______________

Result_________________________________

Test __________________________________

____________________Date_______________

Result_________________________________

• Tell your doctor if you know or suspect you

  are a carrier of the hepatitis B virus. 1.2 During and after GOBIVAZ treatment:

• Seek medical attention immediately if you

  develop symptoms of an infection, such as fever, tiredness, (persistent) cough, shortness of breath, or flu-like signs, weight loss, night sweats, diarrhoea, wounds, dental problems and a burning feeling when urinating.

  1. 2. Pregnancy and vaccinations

In case you have received GOBIVAZ while you were pregnant, it is important that you inform your baby’s doctor about it before your baby receives any vaccine. Your baby should not receive a ‘live vaccine’, such as BCG (used to prevent tuberculosis) within 6 months after your last GOBIVAZ injection during pregnancy.

1. 3. Dates of GOBIVAZ treatment

1^st administration:__________________________ Subsequent administrations:

_________________________________________ _________________________________________ It is important that you and your doctor record the brand name and batch number of your medicine.

1. 4. Other information

Patient’s Name: ___________________________

__________________________________________

Doctor’s Name: ___________________________

__________________________________________

Doctor’s Phone: ___________________________

• Please make sure you also have a list of

  all other medicines that you are using with you at any visit to a health care professional.

• Keep this card with you for 6 months after

  the last GOBIVAZ dose, since side effects may occur a long time after your last dose of GOBIVAZ.

• Read the GOBIVAZ package leaflet

  carefully before you start using this medicine.

get infections more easily. Infections may progress more rapidly and may be more severe. In addition, some previous infections may reappear. 1.1 Prior to GOBIVAZ treatment:

• Tell your doctor if you have an

  infection. You must not be treated with GOBIVAZ if you have

  tuberculosis (TB) or any other

  Dimension: 200 x 70 mm Commodity No.: N/A

  Print Colours: Black

  AMS Component No.: AW-MG-0000038

  Product Description: GOBIVAZ solution for injection in pre-filled Syringe

  Component: Medication Guide Product Code: 106494 - 106495

  Revision Date: 09-Sept-2025