Last Updated: January 2009

Leflunomide

A DRUG Information Sheet

Why am I being prescribed leflunomide?

Leflunomide (brand name Arava) is used to treat rheumatoid arthritis and other types of arthritis where the immune system (the body's own defence system) attacks its own tissues. It is a 'disease-modifying' drug which, by its action on the immune system, can reduce the inflammation that causes pain, swelling and stiffness in the joints.

When and how do I take leflunomide?

Leflunomide is taken in tablet form once a day. Leflunomide can be taken at any time of day, with or without food, and should be swallowed whole. It is best to take it at the same time every day.

What dose do I take?

Your doctor will advise you. Usually you will take either 10 mg or 20 mg a day. For the first 3 days of treatment you may be prescribed a higher dose of 100 mg a day.

How long will leflunomide take to work?

Leflunomide does not work immediately. It may be 4–6 weeks before you feel any benefit and may even be as long as 6 months before you feel the full effect of leflunomide.

What are the possible risks or side-effects?

The most common side-effects of leflunomide are a feeling of sickness, diarrhoea, mouth ulcers, weight loss, abdominal (stomach) pain, headache, dizziness, weakness, skin dryness and hair loss. It may cause a slight rise in your blood pressure.

Leflunomide may cause mild allergic symptoms including rash and itching. Rarely, more severe allergic reactions and skin conditions can develop. If this happens the leflunomide will have to be discontinued.

Taking leflunomide can also affect the blood count (one of the effects is that fewer blood cells are made) and it can make you more likely to develop infections. If you develop a sore throat or other infection, a fever, unexplained bruising, bleeding or rash, or if you become breathless, or develop any other unexpected new symptoms after starting leflunomide, you should tell your doctor or rheumatology nurse specialist straight away. If any of these symptoms are severe, you should stop leflunomide and see your doctor immediately.

If you have not had chickenpox but come into contact with someone who has chickenpox or shingles, or if you develop chickenpox or shingles, you should stop leflunomide and see your doctor immediately as you may need special treatment. This is because chickenpox and shingles can be severe in people on treatment such as leflunomide which has effects on the immune system. Therefore you may require antiviral treatment.

Leflunomide may affect the liver. This may cause problems ranging from abnormalities in the blood tests without causing ill health to severe liver damage which may be fatal. If you develop symptoms such as unusual tiredness, abdominal pain, or jaundice (eyes or skin turning yellow), you should tell your doctor or rheumatology nurse straight away.

If any of these symptoms are severe, you should stop leflunomide and see your doctor immediately.

What other treatments could be used instead of leflunomide?

A number of other drugs are used in the treatment of rheumatoid arthritis and related conditions (see arc leaflet 'Drugs and Arthritis'). Your doctor will discuss these other options with you.

Do I need any special checks while on leflunomide?

Your doctor will arrange for you to have a blood test and blood pressure measurement before you start treatment and then regular checks while on leflunomide. You may be asked to keep a record booklet with your blood test and blood pressure records. Bring this with you when you visit your GP or the hospital. You must not take leflunomide unless you are having regular checks.

May I take other medicines along with leflunomide?

Leflunomide may be prescribed along with other drugs in treating your condition. Some drugs interact with leflunomide (e.g. warfarin, which thins the blood), so 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 leflunomide.

Leflunomide is not a painkiller. If you are already on a non-steroidal anti-inflammatory drug (NSAID) or painkillers you may carry on taking these as well as leflunomide, unless your doctor advises otherwise.

Do not take over-the-counter preparations or herbal remedies without discussing this first with your doctor, rheumatology nurse or pharmacist.

Can I have immunisations while on leflunomide?

It is recommended that you should not be immunised with 'live' vaccines such as yellow fever. However, in certain situations a live vaccine may be necessary (for example rubella immunisation in women of child-bearing age) in which case your doctor will discuss the possible risks and benefits of the immunisation with you.

Pneumovax and yearly flu vaccines are safe and recommended.

May I drink alcohol while taking leflunomide?

Leflunomide and alcohol may interact and damage the liver, so if you drink alcohol you should only drink it in small amounts. Discuss this with your doctor.

Does leflunomide affect fertility or pregnancy?

Leflunomide may harm an unborn baby. Therefore it should not be taken during pregnancy.

While taking leflunomide both men and women must use reliable contraception. If you are planning a family, you should discuss this with your doctor. Women must wait 2 years between stopping leflunomide and becoming pregnant. The 2-year 'waiting' period can be reduced to 3 months if you receive a special 'washout' treatment to help eliminate leflunomide from your body.

Men are advised to stop taking leflunomide, receive the 'washout' treatment, and wait 3 months before trying to father a child.

If you become pregnant while taking leflunomide, you should discuss this with your doctor as soon as possible.

What about breastfeeding?

You should not breastfeed if you are taking leflunomide.

Where can I obtain further information?

If you would like further information about leflunomide, or if you have any concerns about your treatment, you should discuss this with your doctor, rheumatology nurse or pharmacist.

 

Remember to keep all medicines out of reach of children.

PLEASE NOTE: We have made every effort to ensure that the content of this information sheet is correct at time of going to press, but remember that information about drugs may change. This sheet does not list all the uses and side-effects associated with this drug. For full details please see the drug information leaflet which comes with your medicine. Your doctor will assess your medical circumstances and draw your attention to any information or side-effects which may be relevant in your particular case.

6261/D-LEF/09-1

A team of people contributed to this publication. The original text was written by an expert in the subject. It was assessed at draft stage by doctors, allied health professionals, an education specialist and people with arthritis. A non-medical editor rewrote the text to make it easy to understand and an arc medical editor is responsible for the content overall.

This publication has been made possible because of voluntary donations given to the Arthritis Research Campaign. Printed copies can be ordered on this web site or by writing to arc Trading Ltd, James Nicolson Link, Clifton Moor, York YO30 4XX, United Kingdom.