What is certolizumab pegol?

Why is certolizumab pegol prescribed?

What are the possible side-effects?

What are the risks?

What else should I know about certolizumab pegol?

What is certolizumab pegol?

Certolizumab pegol (trade name Cimzia) is a type of drug known as anti-TNF (anti-tumour necrosis factor). In people with rheumatoid arthritis and some other inflammatory diseases a protein called TNF is overproduced in the body, causing inflammation and damage to bones, cartilage and tissue. Anti-TNF drugs block the action of TNF proteins and so reduce this inflammation.

What type of drug is certolizumab pegol?

Certolizumab pegol 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 available for people with rheumatoid arthritis, axial spondyloarthritis (including ankylosing spondylitis, and psoriatic arthritis). 

How is it taken?

It is usually given as a 200 mg injection every two weeks.

Are there any side-effects?

The most common side-effects are reactions at the injection site, such as redness, swelling or pain. It can also make you more likely to develop infections.

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Why is certolizumab pegol prescribed?

It is used to treat moderate to severe rheumatoid arthritis. It is also available for people with axial spondyloarthritis (with or without x-ray evidence of ankylosing spondylitis) or psoriatic arthritis.

Certolizumab pegol won’t be prescribed until you’ve tried other treatments for your condition first.There are guidelines to help doctors decide who the drug is suitable for, depending on what condition people have and how serious it is.

Certolizumab pegol is often prescribed alongside another drug used to treat some autoimmune conditions, called methotrexate.

You can carry on taking non-steroidal anti-inflammatory drugs (NSAIDs) or painkillers if needed, unless your doctor advises otherwise. Don’t take over-the-counter preparations or herbal remedies without discussing this first with your healthcare team

Is there any reason I will not be prescribed certolizumab pegol?

Certolizumab pegol will not be prescribed if:

  • the disease is not active
  • you have not tried standard treatments first
  • you have an infection

Your doctor may decide not to prescribe certolizumab pegol if:

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

When and how do I take certolizumab pegol?

Certolizumab pegol is only available on prescription from a consultant rheumatologist. It is taken by subcutaneous injection (an injection under the skin) into your thigh or tummy. Certolizumab pegol comes in a pre-filled syringe and you, your partner, or another member of your family can learn to give the injections. If this is not possible, the injections can be given by your rheumatology nurse specialist or public health nurse.

How long does certolizumab pegol take to work?

If you respond to certolizumab pegol, you will probably feel better in 2–12 weeks. Because it’s a long-term treatment, it’s important to keep taking certolizumab pegol, unless you have severe side effects, even if it doesn’t seem to be working at first, and even when your symptoms improve, as this will help to keep the disease under control

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What are the possible side-effects?

The most common side-effects are reactions at the injection site such as redness, swelling or pain, but these are not usually serious. Regularly changing the site of injection will help reduce the chances of this irritation. 

Certolizumab pegol affects the immune system (the body’s own defence system), and so you may be more likely to develop infections. You should tell your doctor or rheumatology nurse straight away if you develop any of the following after starting certolizumab pegol:

  • a sore throat
  • a fever
  • any other symptoms of infection, such as coughing up green phlegm or diarrhoea
  • any other new symptoms or anything that concerns you.

What should I look out for?

You should see your doctor immediately if:

  • any of the symptoms listed above are severe
  • you have not had chickenpox and you come into contact with someone who has chickenpox or shingles
  • you develop chickenpox or shingles.

Chickenpox and shingles can be severe in people on treatments like certolizumab pegol that affect the immune system. You may need antiviral treatment, which your doctor will be able to prescribe. Your certolizumab pegol will be stopped if you do develop chickenpox or shingles and restarted when you are better.

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.

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What are the risks?

There may be a slightly increased risk of certain types of cancer in patients using anti-TNF drugs. Such a link has not been proven but is currently being researched. Please discuss this with your doctor if you are worried. Anti-TNF drugs have been associated with certain types of skin cancer – these can be readily treated when diagnosed early.

Very rarely, people taking certolizumab pegol may develop a condition called drug-induced lupus, which is usually mild. The symptoms are a rash, fever and increased joint pain. It can be diagnosed with a blood test. If you develop drug-induced lupus, the drug 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, certolizumab pegol may make you more likely to pick up infections. You should try to avoid close contact with people with 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 on certolizumab pegol 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 vaccination 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 seek advice from your rheumatology team. You may be able to have the shingles vaccine before starting certolizumab pegol. Shingles vaccination is not recommended for people who are already on this medication.

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

Can I drink alcohol while on certolizumab pegol?

You can drink alcohol while using certolizumab pegol, but should not exceed 1–2 units per day for women and 2–3 units per day for men. If you have psoriasis and are also taking methotrexate your doctor may advise lower limits (no more than 4 units per week for men and women). This is because methotrexate and alcohol can interact and damage your liver.

Does certolizumab pegol affect fertility or pregnancy?

If you are thinking of having a baby or if you become pregnant, you should discuss with your rheumatologist. At present there is limited information on the use of certolizumab pegol during pregnancy and how it might affect an unborn baby. Similarly, the effects of certolizumab pegol 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 this drug. However, some women have used other anti-TNF drugs successfully during pregnancy, and it is likely that certolizumab pegol will be similar to these. Guidelines may therefore change as more evidence becomes available.

There may be an increased risk of infections in babies born to mothers using certolizumab pegol. However, at this point in time, it is thought this risk may be less compared to other anti-TNF drugs.  You will need to discuss this further with your rheumatology and obstetric teams.

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

Does it affect breastfeeding?

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

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What else should I know about certolizumab pegol?

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

Will I need any special checks while on certolizumab pegol?

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

Certolizumab pegol may increase the risk of previous hepatitis infections being reactivated. If your doctor thinks you may be at risk from a previous hepatitis infection, they may take a blood test to check whether you are carrying the virus.

Can I take other medicines along with certolizumab pegol?

Certolizumab pegol may be prescribed along with other drugs, including 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 on certolizumab pegol. You should also be aware of the following points:

  • Certolizumab pegol 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, unless your doctor advises otherwise. If certolizumab pegol 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 certolizumab pegol if I am going to have an operation?

If you are going to have an operation please inform your doctor, as you may be advised to stop the certolizumab pegol temporarily before and after surgery.

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