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Patient Information Leaflet

Etanercept

What are the aims of this leaflet?

This leaflet has been written to help you understand more about etanercept (Enbrel™). It tells you what it is, how it works, how it is used to treat skin conditions, and where you can find out more about it.

What is etanercept and how does it work?

Etanercept is a powerful anti-inflammatory drug that has been designed to resemble normal human molecules, and is therefore classed as a “biological” treatment.  It reduces inflammation by inhibiting the activity of a chemical (“cytokine”) in the body called ‘tumour necrosis factor alpha’ (TNF-alpha). 

Which conditions are treated with etanercept?

Etanercept is used to treat psoriasis, psoriatic arthritis, and several other inflammatory conditions, including rheumatoid arthritis. 

Why have I been selected for treatment with etanercept?

The use of etanercept for psoriasis is reserved for those patients with severe psoriasis who have either not responded to, who have not been able to tolerate, or who have a contra-indication to standard treatments such as methotrexate, ciclosporin, acitretin or ultraviolet light therapy. There are national guidelines that assist dermatologists in identifying those patients that might benefit from etanercept.

How long will I need to take etanercept before it has an effect?

Etanercept does not work immediately. It may be 3-12 weeks before you notice any benefit. Around 50-75% of patients achieve a good and worthwhile response.

How do I take etanercept?

Etanercept is taken twice weekly, and has to be injected under the skin.  It must be stored in a refrigerator (at 2 to 8°C) and comes in prefilled syringes. Previously, etanercept needed to be reconstituted (dissolved in water) prior to injection. A nurse or doctor will teach you how to inject yourself: instructions are also given in the package insert. You will be provided with bins to dispose of syringes and needles safely. Travelling with etanercept requires a cool box or cool bag to retain an ideal temperature.

What dose should I take?

The recommended dose of etanercept for an adult patient with psoriasis is 25mgs, taken twice a week (3 or 4 days apart) or 50mg once a week. If there has not been a satisfactory response after 12 weeks it is stopped, but if it has been of benefit it is continued for a further 12 weeks. It may then be restarted if your psoriasis relapses. Some patients may need to continue treatment, particularly if their psoriasis comes back quickly.

What are the possible side effects of etanercept?

Mild

• Reactions where the injection was given These are usually mild and include redness, swelling, itching or bruising: they usually go away within 3 to 5 days. If you have pain, redness or swelling around the injection site that doesn’t go away, or gets worse, seek your doctor’s advice.
• Upper respiratory infections (e.g. sinus infections).
  
• Headache, nausea, vomiting, abdominal pain, depression, itch.

Potentially severe

• Severe infections.  Etanercept may decrease your ability to fight infection. Let your doctor know of any current or past infection (particularly tuberculosis), or if you are prone to infections such as cold sores or cystitis. Please inform your doctor if you have or have ever had any disease that affects your immune system, such as cancer, human immunodeficiency virus (HIV) infection, acquired immunodeficiency syndrome (AIDS) or viral hepatitis. Try to avoid close contact with anyone with a bad cold, flu or chest infections, and wash your hands often while you are taking this medication.
• Nervous system diseases.  There have been rare cases of etanercept affecting the nervous system. Symptoms of this include: numbness or tingling; problems with vision; weakness in the arms and/or legs; and dizziness. Tell your doctor if you have ever had a nervous system complaint, such as multiple sclerosis; Guillain-Barré syndrome; or seizures.
• Blood problems.   Some patients taking etanercept may fail to produce enough of the blood cells that help to fight infections or to stop bleeding. If you develop a fever or sore throat that does not settle, or if you notice bruising or bleeding, or simply look pale, contact your doctor. Blood clots can rarely occur.
• Heart problems.  Etanercept may worsen heart failure: if you have a history of heart problems, you must inform your dermatologist.
• Allergic reactions. Some patients have had allergic reactions to etanercept.  If you develop a severe rash, a swollen face or difficulty with breathing while taking etanercept, this should be regarded as an emergency and you should attend a hospital A & E department immediately, as well as informing your dermatologist.
• Lupus erythematosus-like reaction.  Some people taking etanercept have developed symptoms (such as rash and joint pains) that resemble lupus erythematosus, and these usually go away when you stop taking etanercept.
• Cancers.  Many drugs that decrease the activity of the immune system can increase the chance of getting a cancer. This risk cannot be quantified, but is low. There have been rare reports of lymphoma (a tumour of the lymph nodes) in patients taking etanercept.

What will happen if I need an operation or dental surgery?

Etanercept may increase your risk of getting an infection after a surgical procedure.  You must tell the doctor or dentist that you are taking etanercept.

How will I be monitored for the side effects of etanercept treatment?

You will probably have a chest x-ray and blood tests before treatment starts. Blood checks need to be done only 3 months after commencing etanercept, and 6 monthly thereafter. Monitoring your response and looking out for side effects will take place at regular clinic visits.

The BAD Biologic Interventions Register (BADBIR) Because etanercept treatment for psoriasis is relatively new, you will be asked to take part in a national register if it is prescribed for you. This register will collect valuable information on side effects and benefits and will inform doctors on how best to use infliximab and similar drugs. No information will be passed to the register without your informed consent.

Can I have immunizations (vaccinations) whilst on etanercept?

Neither you nor close contacts should receive any of the 'live' vaccines such as polio, rubella (German measles) and yellow fever, although ‘inactivated’ vaccines are safe. If you are on etanercept, you should avoid contact with children who have been given the 'live' polio vaccine for 4-6 weeks after the vaccination: there is, however, an 'inactivated' polio vaccine available. If you require immunization with a live vaccine, etanercept should be stopped 8 weeks before and until 2 weeks after vaccination. 

Can I receive etanercept if I am pregnant?

It is not known whether etanercept can harm an unborn baby or pass into breast milk, and it is thus prudent to avoid etanercept if you are pregnant or breast-feeding.  Consult your doctor if you become pregnant.

May I drink alcohol while I am taking etanercept?

There is no known interaction between alcohol and etanercept.

Can I take other medicines at the same time as etanercept?

Most medicines are safe to take with etanercept. However, drugs that suppress the immune system, such as steroids, should be avoided.  It is important that any doctor who prescribes for you is aware that you are taking this treatment. Your GP and dermatologist should be aware of all your medications, including over-the-counter medicines and supplements (including herbal medicines).

Can I sunbathe?

Sun beds and sunbathing should be avoided.

Where can I find out more about etanercept?

For full details about etanercept, including a complete list of side effects, read the information sheet which comes as an insert with your prescription for etanercept.

If you are worried about your treatment, you should consult your doctor or pharmacist, or visit the website: http://www.enbrel.com/ 

The British Skin Foundation fund vital research into all skin diseases.  To find out how you can help, please visit the British Skin Foundation website here.

This leaflet aims to provide accurate information about the subject and is a consensus of the views held by representatives of the British Association of Dermatologists: its contents, however, may occasionally differ from the advice given to you by your doctor.

BRITISH ASSOCIATION OF DERMATOLOGISTS
PATIENT INFORMATION LEAFLET
PRODUCED JUNE 2005
UPDATED SEPTEMBER 2009