1. Golimumab is used to treat Ulcerative Colitis, but it doesn’t work for everyone.
2. You take golimumab by injection under your skin (subcutaneous injection).
3. Golimumab affects the way your immune system works. This means you may be more at risk of infections. You may be advised to take extra precautions.
4. Tell your IBD team if you notice any side effects, or if you have signs of an infection.
5. You should not have live vaccines while taking golimumab. You can have the yearly flu jab, as this is not live.

Golimumab is known by the brand name Simponi.

Golimumab is a man-made antibody. The antibody is made from living cells, so it’s known as a biological medicine.

Golimumab targets a protein in the body called tumour necrosis factor-alpha (TNF-alpha). TNF-alpha is naturally produced by your body. It plays an important role helping your immune system fight off infections. But too much TNF-alpha can cause damage to the cells lining the gut. This is thought to partly cause the gut inflammation of people with Crohn’s or Colitis. Golimumab binds to TNF-alpha, blocking its harmful effects and reducing inflammation. This helps to relieve symptoms.

You may also hear golimumab called an ‘anti-TNF’ medicine. Other anti-TNF medicines are:

• Adalimumab (used to treat Crohn’s and Colitis)
• Infliximab (used to treat Crohn’s and Colitis)

Golimumab can be used to treat moderately to severely active Ulcerative Colitis in adults. It may be given to you if other treatments (such as steroids or immunosuppressants, like azathioprine, mercaptopurine or methotrexate):

• Have not worked
• Have caused significant side effects
• Are not suitable for you

You are being offered golimumab to try to get your Colitis into remission. Keeping your Colitis under control is good for your long-term health. It reduces your risk of complications and of needing surgery.

Golimumab is not currently licenced for Crohn’s Disease. Recent research has shown it may be beneficial in some people with Crohn’s who have not responded to other anti-TNF medicines.

Other health conditions

Golimumab is also to treat rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.

You may have been given a choice of biologic medicine. Our information on medicines for Crohn’s and Colitis can help you decide.

There are many things to consider when choosing a treatment. As well as overall effectiveness, you may want to ask your IBD team which medicine is likely to start working fastest. You may also want to think about whether injections or infusions fit better with your lifestyle. Our Guide to Appointments has some questions to get you started. It can help you focus on what matters most to you.

Golimumab can be effective at getting and keeping your Colitis under control (in remission).

Talking about the effectiveness of medicines

To see how effective a medicine is, we can look at data from clinical trials. Clinical trials are used to test a medicine. However, this data may not completely represent what happens when medicines are given to you by your IBD team. In clinical trials, people are often removed from the trial if they do not respond quickly to a medicine. However, this shouldn’t happen when you start taking golimumab. Your IBD team may advise you take it for a longer time to see if you respond. They’ll also make sure the dose is right for you before suggesting you stop taking it. before suggesting you stop taking it. This means golimumab may be more effective than the data from clinical trials shows.

The best clinical trials include people who were not taking the medicine. This is known as a placebo or control group. This is important. It allows us to see how many people have got better because of the medicine, as well as people who may have got better anyway (without the medicine).

Golimumab in Ulcerative Colitis

The table below shows data from clinical trials of golimumab in adults with moderate to severely active Ulcerative Colitis.

More than twice as many people had their Colitis under control (in remission) after taking golimumab for one year compared to people who had not been taking golimumab (placebo). But, not everyone responds to golimumab.

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Everyone responds differently when taking a new medicine. You may feel better soon after starting treatment, but it may take up to 14 weeks.

However, golimumab doesn’t work for everyone. It’s important that you are checked by your IBD team to see how well it is working for you.

Golimumab is given as an injection under the skin. Golimumab cannot be taken by mouth as a tablet because it would be destroyed by your digestive system.

Your treatment will be supervised by your IBD team. The first dose is usually given in hospital, or by a trained nurse at home. You will then be trained to inject this medicine yourself. If you prefer, it may be possible for someone else, such as a family member, to be trained to give you the injections.

Golimumab comes ready to use in either a pre-filled syringe or a pre-filled injection ‘pen’. You may not see the needle in the injection pen, as it’s inside. The syringes or pens come in a pack. The pack also contains an alcohol pad to clean your skin before injecting.

Delivery

Usually, golimumab will be sent directly to your home by a special delivery company. Golimumab can only be prescribed by a specialist in the hospital. It is not a medicine that your GP can prescribe for you to pick up from your local pharmacy. You won’t have to pay for your golimumab prescription, as long as you’re entitled to NHS care.

Storage

Golimumab must be kept in the fridge, or it will not work. But, if you are travelling, it can be stored at room temperature (25°C) out of sunlight for up to 30 days. If it’s not used within this time you will need to get rid of it. Do not put it back in the fridge. Unused medicines should be disposed of safely by your pharmacist. Find out more about travelling with medicines in Travel.

Pain at the injection site is a common side effect. You may also get redness, itching and swelling. You should expect to feel some pain, but these tips can help to make it easier to manage:

• Let your medicine warm to room temperature
  Injecting yourself with cold medicine from the fridge may be uncomfortable. Take it out of the fridge around 30 minutes before you inject, so it can warm to room temperature. Do not warm the injection in any other way, such as in hot water or a microwave.
   
• Choose your injection site
  The upper thigh or stomach (away from the belly button) are good places for the injection. Avoid any areas where the skin is red, scarred, bruised or hard. Use an area at least 3cm away from any previous sites so a hard lump doesn’t form.
   
• Use an ice pack before you inject
  Apply an ice pack to the area for 2-3 minutes before you inject. Place a thin towel between the ice pack and your skin.
   
• Wash your hands and clean the skin at the injection site
  Wash your hands with soap and water. Clean your skin with an alcohol wipe before you inject to reduce the risk of infection.
   
• Use a good injection technique if you use a syringe
  Use a quick, dart-like motion to insert the needle into your skin. Push the plunger slowly and evenly to inject all the medicine and keep pressure on the plunger head. If you use a syringe the injection will take about 2-5 seconds. If you use a pen this will take about 10 seconds.
   
• Use an ice pack after you inject
  An ice pack or cold damp towel may help with pain at the injection site. Do this for about 10-15 minutes. Remember to place a thin towel between the ice pack and your skin.
   
• Wear loose clothing
  Wear loose clothing to avoid rubbing or pressure on the injection site.

If you still have problems with injecting, ask your IBD team for help.

You’ll have a first dose of 200mg, followed by 100mg two weeks later. These induction doses are higher to give a fast response. You’ll then have maintenance dosing every four weeks if you respond well. If you weigh less than 80kg you will usually inject 50mg every four weeks. If you weigh 80kg or more, you will inject 100mg every four weeks.

If golimumab doesn’t work for you, or it becomes less effective, your doctor may suggest that you try a higher dose (for those weighing less than 80kg). This will be based on your symptoms, blood test results and the levels of medicine in your blood. Speak to your IBD team if you think this treatment is not working as well as it should be. You must not make any dose changes unless your IBD team have told you to.

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You may need more than one injection pre-filled pen or syringe for your induction doses.

You are likely to have a planned course of treatment lasting up to a year if golimumab is working well for you. After that, your treatment plan may be extended. You will be checked at least every 12 months to make sure golimumab is still right for you.

There are a few reasons why you and your IBD team may think it’s right to stop or change your treatment:

• Golimumab is not effective – if this medicine hasn’t worked for you within 3-4 months. This will depend on the practice at your hospital. Your IBD team may try changing your dose before suggesting you stop treatment.

• Stable remission - if your condition is in stable remission after 12 months of treatment. If you relapse (have a flare-up) after treatment has stopped, you should be able to start golimumab again. Re-starting anti-TNF treatment will be successful in around 3 in 4 people with Colitis.
   
• Side effects - if you have side effects that are serious or hard to manage.
   
• Golimumab becomes less effective - some people develop antibodies to golimumab over time, which can stop it working.
   
• Issues with injecting yourself – you may prefer to try a treatment which you can receive by an intravenous infusion in hospital.

You have a right to take part in decisions about your treatment. Tell your IBD team what matters most to you, so they can give you the information and support you need. Our Guide to Appointments can help you have these conversations. Do not stop taking your medicine unless your IBD team have said it’s ok. If you have to stop taking this medicine but you’re still unwell, you may be able to try a different biologic. See our information on biologic medicines.

You may take golimumab with other medicines for your Colitis, such , such as 5-ASAs (like mesalazine), thiopurines (azathioprine or mercaptopurine) or methotrexate. Taking more than one medicine is known as combination therapy – for more on this, see our information on taking medicines.

Taking a combination of anti-TNF medicines with azathioprine or methotrexate may be more effective. This can reduces the risk of golimumab becoming less effective over time. You should speak to your IBD team about the risk of extra side effects with combination therapy. You should decide together what the best treatment option is for you

Checks before treatment – such as blood tests and imaging – are important to make sure that golimumab is right for you.

To help your IBD team, tell them if you have a history of:

• Tuberculosis (TB). If you’ve had TB or you’ve recently been with someone who has TB. You should not be given this medicine if you have active TB. If you have underlying, inactive TB, this will need to be treated first. You’ll usually have a chest X-ray to check for TB.
   
• Infections. This includes any past or current infections, or if you are generally feeling unwell or feverish. You may need to delay your treatment if you have an infection.
   
• HIV, hepatitis B or C. This includes any past or current infections, if you are a carrier of hepatitis B or C (a liver infection caused by a virus), or have been in close contact with someone who has hepatitis B or C. You will have a blood test to check for these diseases.
   
• Heart problems. Your heart will need to be monitored closely before, during, and after treatment as it could make your heart problems worse.
   
• Cancer. Golimumab affects how your immune system works and may increase the risk of some types of cancer. You may also be at risk even if you do not have a history of cancer.
   
• Pre-existing conditions, including allergies, COPD (Chronic Obstructive Pulmonary Disease), asthma, kidney disease, liver disease, multiple sclerosis or any other disease or symptoms affecting the nervous system.
   
• Latex allergy. The needle cover of the pre-filled pen or pre-filled syringe is made from rubber containing latex and may cause an allergic reaction.
   

And tell your IBD team if:

• You smoke
• You are pregnant, planning to get pregnant or are breastfeeding
• You are taking any other medicines
• You have had any vaccinations recently or plan to have any
• You have had surgery, or plan to have surgery or dental treatments
• You travel to regions of the world where TB or fungal infections (such as histoplasmosis, coccidioidomycosis or blastomycosis) are common
• You have ever had chicken pox, shingles or measles. You may be able to be vaccinated against these before you start treatment.

You’ll need regular checks while taking golimumab, including blood tests. This helps your IBD team fit your treatment to your needs. It can help make sure that any problems with treatment are avoided or caught at an early stage. Tell your IBD team if you notice any new symptoms or side effects.

It’s important that you attend your appointments and have blood checks to make sure this medicine is prescribed safely.

If you feel dizzy or tired after taking this medicine do not drive or use any tools or machines.

This medicine affects the way your immune system works. Your immune system is still able to fight off infections, just not quite as well as other people. You may find that infections affect you more than they used to, or it takes you longer to recover. Tell your IBD team if you develop signs of an infection, such as a sore throat, fever or any new symptoms that concern you. They may advise you to wait until you feel better before injecting. Less often, more serious infections can be a side effect of golimumab. See the section below on Side effects.

Even though your risk of complications may be higher when taking golimumab, it shouldn’t stop you from living life as before. There are a few extra precautions your IBD team may advise you to take to keep safe and reduce your risk:

• Have the yearly flu jab. You may also be advised to have a pneumococcal vaccine. Ask your IBD team if you’ll need to have this just once, or every 5 years.
   
• Avoid close contact with people who have serious infections. This includes chickenpox and shingles, measles, TB and pneumococcal disease. Tell your IBD team if you come into contact with anyone with these conditions, even if you don’t feel unwell.
   
• Practice good hand washing hygiene. You’re still able to go out and socialise as before, but it’s sensible to be more careful. Wash your hands regularly with soap and water (or use an alcohol-based hand gel) – especially before eating and after using public transport. Try to avoid touching your face when your hands are not clean.
   
• Practice good food hygiene. You may be at risk of more severe infections caused by bacteria found in food, such as Listeria or Salmonella. Avoid eating raw eggs or undercooked pate, meat and poultry, as well as unpasteurised milk or cheeses. Nearly all dairy sold in UK supermarkets is pasteurised and safe to eat. This includes soft and ‘blue’ cheeses – just check the label if you’re unsure. Ask whether unpasteurised milk was used when buying soft cheese from farmers’ markets or abroad.
   
• Take care in the sun. You may be more at risk of skin reactions, and in rare cases skin cancer. Taking azathioprine and mercaptopurine in combination with golimumab can increase this risk. Practice good sun safety, such as wearing a hat and high factor sunscreen, staying in the shade and avoiding sunbeds. The NHS website has more tips for staying safe in the sun.
   
• Women and people with a cervix should attend routine screening for cervical cancer (previously known as the smear test). Abnormal cell changes in the cervix are caused by the human papilloma virus (HPV). Immunosuppressed women are more likely to have these abnormal cell changes. However, there is no evidence linking cervical cancer to the use of golimumab or other biologics. There’s no need to be tested more often than other women. You’ll be invited to routine screening by your GP.

All medicines can have unwanted effects, although not everyone will get them. Some side effects can happen right away, others may happen later. Some can even last for a short time after you stop treatment.

Some side effects may be mild and go away on their own or when the medicine is stopped. Others may be more serious and will need managing, or may mean that the treatment is not right for you. Try to consider how unwell any side effects are making you feel, as well as the benefits of taking this medicine to keep your Colitis under control.

Speak to your IBD team if you experience any side effects.

Most common side effects

Around 1 in every 10 people taking golimumab may have upper respiratory tract infections (like colds, with symptoms including a sore throat and a runny or blocked nose).

Other side effects

• Infections. You may need to delay taking golimumab if you have an infection. Ask your IBD team for advice.
  • Common: Flu, pneumonia, sinus infection, conjunctivitis (eye infection). More serious infections include cellulitis (a bacterial skin infection).
  • Uncommon: Sepsis (when your immune system overreacts to an infection, damaging your body).
  • Rare: You may be at greater risk of developing TB, or reactivating underlying TB reactivated.
     
• Changes in your mental health.
  • Common: Depression or trouble sleeping.
     
• Gut problems. Some of these will be similar to the symptoms of Crohn’s or Colitis. Speak to your IBD team if you’re not sure what’s causing your symptoms.
• Common: Tummy pain, feeling sick (nausea), indigestion or inflamed mouth and lips.
   
• Nervous system problems.
  • Common: Dizziness, headaches or pins and needles.
  • Rare: Demyelination disorders (damage to nerves).
     
• Blood problems. Symptoms include a fever that does not go away, bruising or bleeding very easily, sore throat, or looking pale.
  • Common: Anaemia (low iron) or your body may not make enough of the blood cells that help to stop bleeding.
  • Uncommon: Your body may not make enough of the blood cells that help to stop bleeding.
     
• Liver problems. Tell your doctor if your skin or eyes look yellow, you feel very tired with a lack of appetite, or you have ongoing pain on the right side of your tummy (abdomen).
  • Common: Changes in liver enzymes.
  • Rare: Golimumab can activate viral hepatitis if you carry it in your blood. Your doctor will check if you are a carrier before you start treatment.
    ​
• Heart problems. Tell your doctor straight away if you have new or worsening shortness of breath, swelling of your ankles or feet, or sudden weight gain.
  • Uncommon: Arrhythmia (an abnormal heart rhythm) or coronary heart disease.
  • Rare: New or worsening heart failure.
     
• Skin reactions. Some of these can be treated without stopping golimumab.
  • Common: Rash, itch, eczema or alopecia.
  • Uncommon: Psoriasis (new or worsening) or other skin conditions that can cause ulcers or blisters.
     
• Some types of skin cancer. You must tell your doctor if you have a bump or open sore which is not healing.
  • Rare: Melanoma.
  • Other types of cancer. This medicine may not be right for you if you’ve previously had cancer.
  • Rare: Lymphoma or leukaemia (types of blood cancer).
  • Not known: A rare and serious cancer called hepatosplenic T-cell lymphoma (HSTCL). HSTCL has been reported in some people taking anti-TNF medicines in combination with azathioprine or 6-mercaptopurine. Most cases have been in males with Crohn's under the age of 35. The risk hasn't been measured – but it is a rare cancer, and rarer still in people taking these medicines.

How common are these side effects?

Common: Somewhere between 1 in every 10 people to 1 in every 100 people taking golimumab may develop this side effect.

Uncommon: Somewhere between 1 in every 100 people to 1 in every 1000 people taking golimumab may develop this side effect.

Rare: Somewhere between 1 in every 1000 people to 1 in every 10,000 people taking golimumab may develop this side effect.

This is not a full list of side effects. For more information see the Patient Information Leaflet provided with your medicine or visit medicines.org.uk/emc/.

We encourage you to report any side effects to the Medicines and Healthcare Products Regulatory Agency (MHRA) through the Yellow Card scheme. Your doctor should also report it. Report your side effect at yellowcard.mhra.gov.uk.

Golimumab is often taken alongside other medicines safely. See the earlier section Taking golimumab with other Colitis treatments.

However, golimumab may interact with other medicines. Speak to your doctor or pharmacist if you’re taking, or plan to take any other medicines. This includes over-the-counter medicines (medicines that you buy yourself) and any herbal, complementary, or alternative medicines or therapies.

Do not take medicines that contain anakinra or abatacept. These medicines are commonly used for Rheumatoid Arthritis.

Telling other health professionals

Tell any doctor, dentist or health professional treating you that you are taking golimumab. Always carry the alert card that comes with the medicine while you are taking it and for up to six months after your last dose.

It’s not safe to have ‘live’ vaccines while taking golimumab. It can take up to five months after your last dose for golimumab to completely leave your body. However, it’s safe to have live vaccines 3 months after your last dose. Ask your IBD team to make sure your vaccinations are up to date before you start adalimumab, or if you’re planning to travel. If you’ve recently had a live vaccine you may have to wait 4 weeks before starting golimumab.

In the UK, live vaccines include:

• BCG (tuberculosis)
• Chicken pox (varicella)
• Measles, mumps and rubella (either as individual vaccines or as the triple MMR vaccine)
• Yellow fever
• Rotavirus (babies only)
• Flu nasal spray (children only)

Everyone with Crohn’s or Colitis taking a biologic medicine should have the yearly flu vaccine. This is not a live vaccine and is safe to have while taking golimumab.

If someone you live with is due to have a live vaccine, ask your IBD team if you need to take any precautions.

Golimumab does not affect fertility. If you don’t want to get pregnant you should use contraception.

Talk to your IBD team if you're taking golimumab and planning a pregnancy or are already pregnant. If you decide to continue taking golimumab, it should not stop you from having a normal pregnancy and a healthy baby. Research shows that anti-TNF medicines, like golimumab, do not have affect your pregnancy, or harm your baby. Long-term health, infection rates and development do not appear to be affected in children of mothers taking anti-TNFs during pregnancy. This includes mothers who took anti-TNFs until birth).

Golimumab does not appear to affect foetuses, but there hasn’t been enough research to rule out the possibility completely. To be cautious, drug companies state that should only be used during pregnancy if needed to keep your condition under control. This is because the medicine could cross the placenta. They recommend using contraception to prevent pregnancy while taking golimumab and for at least six months after your last dose. However, as golimumab is generally considered safe. Your IBD team may advise the safest option is to keep taking it during pregnancy to keep your Colitis under control.

When deciding whether to continue taking golimumab, you should also consider the risks of having a flare-up while you’re pregnant. Having active Crohn’s or Colitis can lead to premature (early) birth, low birth weight and rates of miscarriage. It’s important to keep your condition under control in pregnancy. If your Colitis is not well controlled (in remission), then your IBD team may recommend you take golimumab for the first six months (first and second trimesters), but stop during the third trimester. This aims to reduce the exposure of your baby. If your condition is not well controlled, your IBD team may recommend you take golimumab throughout your entire pregnancy to keep you well.

Taking golimumab during pregnancy is likely to affect when your baby can have any live vaccines. This includes the BCG for tuberculosis and the rotavirus vaccine. It should not affect the rest of your baby’s vaccination schedule.

National guidance advises that if you take golimumab during your pregnancy your baby should not have live vaccines until they are at least six months old. However, golimumab drug companies advise that your baby should not have any live vaccines for six months after your last adalimumab dose during pregnancy.

You must tell your baby’s healthcare team you were taking golimumab while pregnant. Decisions on what vaccines your baby should have and when they should have them needs to be made on an individual basis. Your IBD team and midwife should be able to help you come to a decision.

Take extra care if your baby does have the rotavirus vaccine, as live virus can be shed in the baby’s poo for up to 14 days. Make sure you wash your hands and/or wear gloves when changing their nappy.

There is some evidence that your baby may be more prone to infections if you take azathioprine or mercaptopurine along with anti-TNFs, like golimumab, during pregnancy.

Discuss the risks and benefits of taking golimumab while pregnant with your doctor and IBD team. You can find out more in our information on pregnancy and reproductive health.

There is less research on men wanting to father a child while taking anti-TNF medicines. But, it’s generally considered safe for a man to conceive a child.

You can take golimumab while breastfeeding. Small amounts of golimumab have been found in breast milk in animal studies, but golimumab hasn’t been found in human breast milk.

The drug company advises that you stop taking golimumab at least six months before you start breastfeeding. However, there is very little risk to your baby. Your IBD team may suggest you keep taking golimumab while breastfeeding if it’s keeping your Crohn’s or Colitis under control. Golimumab is destroyed by the digestive system when taken orally, so it wouldn’t be absorbed by your baby. Speak to your IBD team if you’re worried.

Alcohol is not known to have any interaction with golimumab.

Taking medicines and managing side effects can be difficult – we understand and we’re here to help. Our Helpline can answer general questions about treatment options and can help you find support from others with the conditions.

Your IBD team are also there to help. You can talk to them about your dosage, how they’ll be monitoring you and what alternatives may be available. You should also get in touch with your IBD team if you have any new symptoms or side effects.
 
It can take time to find the medicine that’s right for you. Don’t be afraid to ask questions and seek out extra support when you need it.

This information is general and doesn’t replace specific advice from your health professional. Talk to your doctor or IBD team for more information. You can also check the Patient Information Leaflet that comes with your medicine or visit medicines.org.uk/emc/. 

We follow strict processes to make sure our information is based on up-to-date evidence and easy to understand.

Please email us at evidence@crohnsandcolitis.org.uk if:

• You have any comments or suggestions for improvements
• You would like more information about the sources of evidence we use
• You would like details of any conflicts of interest

You can also write to us at Crohn’s & Colitis UK, 1 Bishop Square, Hatfield, AL10 9NE, or contact us through our Helpline: 0300 222 5700