LEFLUNOMIDE (Arava®) INFORMATION SHEET

Developed by Andy Thompson MD FRCPC

What is Leflunomide?

Leflunomide is a Disease Modifying Anti-Rheumatic Drug (DMARD). It is used for the treatment of Rheumatoid arthritis, Psoriatic arthritis, and many other types of arthritis.

How does Leflunomide work?

Leflunomide works by suppressing the body’s immune system. Although this suppression can make it slightly harder for you to fight off infections, it also stabilizes the immune system if it is overactive.

Why am I taking Leflunomide?

Your doctor has prescribed this medicine to help with the following:

1. Reduce the pain and swelling (inflammation) in your joints.
2. Improve your day to day function.
3. Prevent any long-term damage from the joint inflammation.

What is the usual dose of Leflunomide?

• Leflunomide is taken by mouth (tablets) and is available in 10, 20, and 100 mg tablets.
• The typical dose of leflunomide is either 10 or 20 mg a day.

How often do I take Leflunomide?

• Leflunomide is only taken ONCE A DAY or occasionally every other day.

Who should NOT take Leflunomide?

• Patients who have had a previous serious reaction to Leflunomide.
• Women who are pregnant, planning on becoming pregnant, or currently breast feeding.
• Men who are planning pregnancy with their partner.
• Patients with diseases of the liver, kidney, or blood disorders.
• Patients with active infections.

When will I start to feel the effects of Leflunomide?

Leflunomide does not work right away. It will usually take about 6 to 8 weeks before you start feeling better. The maximum effect can take up to 6 months. If your doctor changes the dose, it can take another 6 to 8 weeks before you start feeling the effects.

What should I AVOID while taking Leflunomide?

• Alcohol intake should be used in moderation.
• Avoid pregnancy.

Which Medications are safe to take with Leflunomide?

Your rheumatologist may decide to add other medications to treat your arthritis. Most medications can be safely taken with Leflunomide. As an example, some of the other medications which may be safely added to Leflunomide include: Acetaminophen, (Tylenol) Prednisone, Other DMARDs (i.e. Sulfasalazine, Methotrexate, Hydroxychloroquine, and Gold), and Biologics (i.e. Etanercept, Infliximab, Anakinra).

What are the side-effects of Leflunomide?

MORE COMMON side-effects include:

• Nausea and diarrhea.
• Skin rash
• Hair thinning or loss which is reversible when the medication is stopped.

RARE side-effects include:

• Increase in blood pressure.
• Liver - Leflunomide may irritate the liver. This does not usually cause symptoms but may be found on blood tests. It is rare and usually reversible when regularly monitored with your monthly blood tests.
• Bone Marrow - Leflunomide can cause a drop in the numbers of white blood cells (which are needed to fight infection) and platelets (which help to stop bleeding). Because we monitor the blood count very closely, it is unusual for this to be a serious problem.
• Infection - Any infections or fevers should be taken seriously and reviewed by your doctor.

How can I help to minimize the side-effects of Leflunomide?

• Take your Leflunomide as prescribed by your doctor.
• Reducing the dose to 10 mg per day or taking the medicine every other day (20 mg) may be helpful in reducing side-effects.

Do I need to have regular blood tests while taking Leflunomide?

YES, you will need BLOOD TESTS EVERY 1 - 3 MONTHS. This is important to make sure the Leflunomide is having no harmful effects on your liver or bone marrow.

How do I stop the Leflunomide?

You do not need to wean yourself off the Leflunomide. It can simply be stopped. However, your arthritis may flare after you stop the medicine.

What should I do if I miss a dose of Leflunomide?

• If you forget to take your Leflunomide at the usual time but remember later on the same day, take the missed dose immediately.
• If you forgot to take yesterday’s dose, skip yesterday’s dose and take your usual dose for today.

Is Leflunomide safe in pregnancy?

• Leflunomide may cause birth defects and result in miscarriage. You must AVOID PREGNANCY while on Leflunomide.
• All women of child bearing potential taking Leflunomide must use reliable contraception.
• If you are considering pregnancy in the near future you should consider using a different medication as Leflunomide can stay in the body for up to two years.
• If you become pregnant while taking Leflunomide NOTIFY YOUR DOCTOR IMMEDIATELY.