This information has been provided with kind permission from Crohn’s and Colitis UK – a nationwide charity committed to providing information and support, funding crucial research and working to improve healthcare services for anyone affected by Inflammatory Bowel Disease.

OTHER NAMES FOR THIS MEDICINE:

Golimumab is a biological drug, meaning it originates from a natural source rather than a mixture of chemicals. It is also known by the brand name Simponi.

WHY AM I BEING TREATED WITH GOLIMUMAB?

Golimumab can be used to treat moderately to severely active Ulcerative Colitis in adults. It may be considered a suitable treatment when other drugs have not worked or have caused major side effects. It is not currently licensed for Crohn’s Disease, although some people have found it effective.

HOW LONG WILL IT TAKE TO WORK?

People react differently to medication, and golimumab doesn’t work for everyone.  You may begin to feel better within a few days, though for some people it can take up to a few months after the first treatment session before they notice an improvement.

HOW DO I TAKE GOLIMUMAB?

Golimumab is given as a subcutaneous injection, which is an injection under the skin. It cannot be taken as a tablet because your digestive system would destroy it.  A nurse will give you the injections to begin with, and will train you to do the injections yourself when you are ready. This may be done by your IBD nurse, or by a nurse arranged through the delivery company that will deliver the golimumab directly to your home at a convenient time each month. If you prefer, it may be possible for someone else, such as a family member or a friend, to be trained to give the injections.

Golimumab comes ready to use in either a pre-filled syringe or a pre-filled injection ‘pen’. It should always be stored in the fridge, ideally on the middle shelf and not touching the back or sides of the fridge. The syringes or pens come in a pack, which also contains an alcohol pad for cleaning the skin before injecting. The injection is usually given under the skin of your thigh or stomach, but not in the area around your stomach button or navel. It should not be given in any area where the skin is reddened, bruised or hard, and a new injection site should be at least 3cm away from any previous injection sites. If you use a syringe the injection will take about 2-5 seconds. If you use a pen it will take about 10 seconds.

WHAT IS THE NORMAL DOSAGE?

When you first start taking golimumab, you will be given a starting dose of 200mg, followed by 100mg two weeks later. After this induction treatment, you will inject your golimumab every four weeks. 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.

HOW LONG WILL I BE TAKING IT?

If you respond well to golimumab, you may be put onto a planned course of treatment lasting up to a year or longer. Your treatment plan will be reassessed at least every 12 months to check whether continuing with golimumab is still right for you. If you are in stable remission, it may be decided that you can stop taking golimumab. If after stopping treatment you become unwell again, you should have the option to restart golimumab. You may also be taken off  golimumab if you have serious side effects or if you have not responded strongly enough within 8 weeks.

IS GOLIMUMAB USED IN COMBINATION WITH OTHER DRUG
TREATMENTS FOR IBD?

Golimumab is sometimes given in combination with steroids to help bring on remission and allow the steroid treatment to be reduced. Golimumab may also be given in combination with immunosuppressants such as azathioprine. See our
information sheet on Taking Medicines for more information on taking more than one medicine, which is known as combination therapy.

HOW EFFECTIVE IS GOLIMUMAB?

Golimumab is used to treat a range of conditions including Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis as well as Ulcerative Colitis. Although not everyone will respond to golimumab, it has been shown to be effective in treating UC, resulting in improvement of symptoms as well as healing of the intestines for some people. It can help to reduce the need for hospitalisation and surgery, and may mean that you do not have to take steroids. People who have never tried other anti-TNF drugs (such as infliximab or adalimumab) before may respond better to golimumab. Even so, golimumab can be effective for people who have tried these drugs before.

WHAT ARE THE MOST LIKELY SIDE EFFECTS OF GOLIMUMAB?

Like all drugs, golimumab can have side effects, although not everybody will get them. Some side effects can happen almost immediately, while others may develop later. It can take up to six months after the last dose for golimumab to completely leave the body, so some effects might appear even after stopping treatment. Some possible golimumab side effects are likely to be quite mild and may go away on their own. Others can be more serious and will require treatment, or may mean that golimumab is not suitable for you.

IMMEDIATE REACTIONS

• Reactions to the skin at the site of the injection, such as redness, hardness, pain, bruising, itching, tingling and irritation. This can be very common, affecting up to one in 10 people. Using golimumab when it is at room temperature or cooling your skin with an ice pack may help.  Your doctor or IBD nurse should also be able to advise you on how to reduce this sort of reaction.

• Symptoms that mean you are having an allergic reaction to golimumab. For example, rashes, hives (a raised itchy rash that appears on the skin), a swollen face, hands and feet, or trouble breathing and shortness of breath.

OTHER SIDE EFFECTS

It is common for people taking golimumab to develop upper respiratory tract infections, a sore throat or a runny nose. Other common side effects include:

• Cold sores and mouth ulcers
• Nausea
• Superficial fungal infections
• Headache
• Indigestion and stomach pain
• Feeling weak or numb
• Sinus infections
• Depression
• High blood pressure

In rare circumstances, people can develop more serious side effects to golimumab. Many of these are reversible if the drug is stopped. These include demyelination (damage to nerves), inflammatory conditions such as lupus, tuberculosis, nervous system diseases such as multiple sclerosis, heart failure, and in exceptional cases, cancer of the blood, skin or lymph nodes. Seek medical advice immediately if you develop any of the following symptoms:

• Swelling of the face, lips, mouth, throat or feet
• Difficulty swallowing or breathing
• Fatigue, cough, weight loss or flu-like symptoms
• Changes in your vision
• Numbness or tingling
• Persistent fever, bruising, bleeding or paleness
• Weakness in your arms or legs
• Night sweats
• A burning feeling when urinating
• Dark brown-coloured urine

You should let your doctor or IBD nurse know about any new symptoms you develop while on golimumab, whenever they occur. Your IBD team should also be able to help with any queries and concerns.

This is not a complete list of side effects for golimumab. For more information see the Patient Information Leaflet provided with your medication, or visit www.medicines.org.uk/emc. The Medicines and Healthcare Products Regulatory Agency (MHRA) has a Yellow Card scheme to encourage people to report any suspected side effects they experience from medicines. Visit www.mhra.gov.uk to find out more.

DOES GOLIMUMAB AFFECT PREGNANCY?

If you’re taking golimumab and thinking of starting a family or becoming pregnant, discuss this with your IBD team. The evidence about the safety of golimumab during pregnancy is limited, with most research focusing on anti-TNF drugs in general. However, the research is very reassuring, with no evidence of harm to mother or baby. As there is not yet much clear evidence about golimumab in particular, the manufacturers recommend that if you have the potential to become pregnant, you should use adequate contraception to prevent pregnancy while you are on golimumab and for at least 6 months after stopping golimumab. Your doctor may consider alternative medications for you during pregnancy. However, most doctors consider that if golimumab is keeping your IBD in check, it may be better to continue with it, at least until the end of the second trimester (the sixth month of pregnancy). There is less evidence for those wanting to father a child while on anti-TNF drugs, but it is thought that it is safe for a man to conceive a child.

For further, more detailed information please download the full patient publication from Crohn’s and Colitis UK

This information is designed to answer common questions you may have if you have been given azathioprine or mercaptopurine to treat your Crohn’s Disease or Ulcerative Colitis, the two main forms of Inflammatory Bowel Disease (IBD). It is not intended to replace specific advice from your own doctor or any other health professional. You can obtain further information from your doctor, pharmacist, the information leaflet supplied with your medication or from the website: http://www.medicines.org.uk

© Crohn’s and Colitis UK 2018