What is Golimumab?

Why is Golimumab prescribed?

What are the risks?

What else should I know about Golimumab?

What is Golimumab?

Golimumab (trade name Simponi) is an anti-TNF (anti-tumour necrosis factor) drug. TNF is a protein which is found in everyone’s blood as part of the body’s normal response to infection. However, in rheumatoid arthritis and some other inflammatory diseases, abnormal production of TNF causes inflammation and damage to bones, cartilage and tissue. Anti-TNF drugs block the action of TNF and so reduce this inflammation. Golimumab is a type of drug known as a biological therapy.

What type of drug is golimumab (brand name Simponi)?

Golimumab is an anti-TNF (anti-tumour necrosis factor) drug.

What does it do?

It blocks the action of TNF proteins and so reduces inflammation.

What is it used for?

It is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis .

How is it taken?

It is usually given as a 50 mg injection on the same day every month.

Are there any side-effects?

Potential side-effects include reactions at the injection site, such as redness, swelling or pain. Golimumab can also make you more likely to develop infections.

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Why is Golimumab prescribed?

Golimumab is available for people with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis.

Golimumab will only be prescribed for rheumatoid arthritis and psoriatic arthritis if your arthritis is active, you have already tried methotrexate or another disease-modifying anti-rheumatic drug (DMARD) such as sulfasalazine, or if you cannot use these drugs for any reason.

Golimumab will only be prescribed for ankylosing spondylitis if you have severe disease that has not responded to two or more non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen.

Is there any reason I will not be prescribed golimumab? 

Golimumab will not be prescribed if:

  • your arthritis is not active
  • you have not tried standard treatments first
  • you have an infection.

Your doctor may decide not to prescribe golimumab if:

  • you have had tuberculosis (TB)
  • you have had other repeated infections
  • you have multiple sclerosis (MS)
  • you have had cancer
  • you are pregnant or breastfeeding
  • you have or have had a serious heart condition
  • you have lung fibrosis (scarring of lung tissue).

You should always read the patient information leaflet included with your medicines package to keep you informed about any possible side effects of your prescribed medications.

When and how do I take golimumab?

Golimumab is only available on prescription from a consultant rheumatologist. It is given once a month by subcutaneous injection (an injection under the skin), usually into your thigh, tummy or upper arm. It comes in a 50mg ‘pen’ device or a syringe which you or another member of your family can learn to use. If this is not possible, you may be able to arrange for the injections to be given by your rheumatology nurse or district nurse.

How long does golimumab take to work?

If you respond to golimumab you will probably feel better in 12–14 weeks (after three or four doses).

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What are the risks?

Anti-TNF drugs have been associated with some types of skin cancer. However, the link between the two is unclear. Skin cancers can often be treated successfully when diagnosed early. To be on the safe side, make sure to wear sunscreen and regularly check your skin for any new spots or changes to your freckles or moles. 

Very rarely, golimumab can cause a condition called drug-induced lupus. This is usually mild and can be diagnosed by a blood test. The symptoms include a rash, fever and increased joint pain. If you develop drug-induced lupus, golimumab will be stopped and the condition then usually disappears.

How can I reduce the risk of infection?

Because of its effects on the immune system, golimumab may make you more likely to pick up infections. You should try to avoid close contact with people who have severe active infections, and visit the Food Safety Authority of Ireland website www.fsai.ie for information on reducing your risk of infection from foods.

Will it affect vaccinations?

If you are taking golimumab it is recommended that you avoid live vaccines such as yellow fever. However, in certain situations a live vaccine may be necessary (for example rubella immunisation in women of childbearing age), in which case your doctor will discuss the possible risks and benefits of the vaccination with you.

If you are in your 70s and are offered shingles vaccination (Zostavax) you should discuss this with your rheumatology team. You may be able to have the shingles vaccine before starting golimumab. Shingles vaccination is not recommended for people who are already on golimumab.

Pneumovax (which gives protection against the most common cause of pneumonia) and yearly flu vaccines are safe with golimumab and recommended.

Can I drink alcohol while on golimumab?

You can drink alcohol while on golimumab. If you are also taking methotrexate, you should only drink alcohol in small amounts – generally no more than 1–2 units per day for women and 2–3 units per day for men, though your doctor may advise lower limits if you have psoriasis and/or you are also taking methotrexate. This is because methotrexate and alcohol can interact and damage your liver. Alcohol can also worsen psoriasis.

Does golimumab affect fertility or pregnancy?

If you are thinking of having a baby or if you become pregnant, you should discuss this with your rheumatologist. At present there is an absence of information on the use of golimumab during pregnancy and how it might affect an unborn baby. Similarly, the effects of golimumab on men trying to father a child are uncertain, though it is not thought to affect fertility.

Generally, it is recommended that men and women use contraception while on golimumab. However, some women have used other anti-TNF drugs successfully during pregnancy, and it is likely that golimumab will be similar to these. Guidelines may therefore change as more evidence becomes available.

As with other anti-TNF drugs, there may be an increased risk of infections in babies born to mothers using golimumab during pregnancy. Your rheumatology and obstetric teams will advise you about delaying your baby’s live vaccination schedule in view of the risk of infection.

If you are taking methotrexate this drug should be stopped three months before trying for a baby.

Does it affect breastfeeding? 

Generally, it is recommended that you do not breastfeed if you want to re-start golimumab after pregnancy as it is not known whether golimumab may pass into your breast milk. However, limited studies of other anti-TNF drugs suggest that little or no drug gets into the breast milk. You should discuss with your doctor whether to use golimumab whilst breastfeeding. There may be an increased risk of infections in your baby if you use golimumab while breastfeeding and your baby then receives a live vaccine.

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What else should I know about Golimumab?

If you are being prescribed golimumab it is recommended that you carry a biological therapy alert card, which you can obtain from your doctor or rheumatology nurse. Then if you become unwell, anyone treating you will know that you are on golimumab and that you are therefore at risk of its side-effects, including infections.

Are there any alternatives?

A number of other drugs are used in the treatment of rheumatoid arthritis and other inflammatory conditions. Your doctor and rheumatology nurse will discuss these with you.

What happens if I forget to take a dose of golimumab?

If you forget a dose, you should take it as soon as you remember.

  • If it is less than 2 weeks late, you should inject the forgotten dose and stay on the original monthly schedule.
  • If it is more than 2 weeks late, you should inject the forgotten dose and start a new schedule from the date of this injection.
  • NEVER inject a double dose to make up for the forgotten dose.

Will I need any special checks while on golimumab?

You will have a chest x-ray and blood tests, and screening to check whether you have ever been exposed to tuberculosis (TB) or hepatitis. Some patients may need a course of treatment for latent (asymptomatic) TB before starting golimumab. You may also have further blood tests while you are on golimumab to monitor its effects.

Golimumab may increase the risk of a hepatitis infection being reactivated if you carry the virus. If your doctor thinks that you may be at risk from a previous hepatitis infection, they may test your blood for the presence of hepatitis.

Can I take other medicines alongside golimumab?

Depending on your condition, you may need to take other medication alongside golimumab. If you have rheumatoid arthritis you will also be prescribed methotrexate. If you have psoriatic arthritis you may also be prescribed methotrexate.

You should discuss any new medications with your doctor before starting them, and you should always tell any other doctor treating you that you are taking golimumab. You should also be aware of the following points:

  • Golimumab is not a painkiller. If you are already on a non-steroidal anti-inflammatory drug (NSAID) or painkillers you can carry on taking these as well as golimumab, unless your doctor advises otherwise. If golimumab works for you, you may be able to reduce your NSAIDs or painkillers after a time.
  • Do not take over-the-counter preparations or herbal remedies without discussing this first with your doctor, rheumatology nurse or pharmacist.

Can I continue with golimumab if I am going to have an operation?

If you are going to have an operation, please discuss this with your doctor. Depending on the type of surgery, you may be advised to stop taking golimumab before your operation and for two weeks after your wound has healed.

It may take up to five months for golimumab to pass through your body, so even if you stop taking it your immune system may be affected for some time. You should therefore report any signs of infection (such as fever, cough or pain on passing water) to your doctor.

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