Leflunomide for rheumatoid arthritis

Leflunomide is given by mouth (orally).

Leflunomide (Arava) is a disease-modifying antirheumatic drug (DMARD) that is used to treat rheumatoid arthritis. It works by blocking the production of white blood cells, which are needed to cause inflammation in the joints (and thus interferes with the progression of the disease). Because it blocks the natural response of the immune system, leflunomide is considered an immunosuppressive drug.

Leflunomide is used to treat active rheumatoid arthritis in adults to relieve symptoms and slow the progression of the disease. Leflunomide is considered a choice for people with active rheumatoid arthritis who have not responded to methotrexate or sulfasalazine.¹

Leflunomide can improve symptoms, slow or prevent the disease from getting worse, and improve function in people with rheumatoid arthritis. It also seems to be well-tolerated and slows disease progression as seen on X-rays.

Side effects of leflunomide include:

• Increased risk of infection.
• Diarrhea and abdominal pain.
• Nausea, vomiting, or decreased appetite.
• Skin rash or hair loss.
• Liver inflammation.
• Lower blood counts.

Risk of infection

Leflunomide decreases the activity of your body's immune system, which increases the risk of a serious bacterial infection. Some people who take leflunomide develop an infection that requires oral antibiotics; a smaller number of people will develop an infection that requires intravenous antibiotics and hospitalization. Contact your health professional if you develop any of the following symptoms:

• Fever and chills
• Increased frequency of or burning during urination
• A cough with yellow sputum or shortness of breath
• A skin infection
• Severe abdominal pain or diarrhea
• A severe sore throat
• Sinus pain with yellow mucus
• A painful, burning rash in a band across one side of your body (shingles)
• Painful, widespread mouth sores

See Drug Reference for a full list of side effects. (Drug Reference is not available in all systems.)

Leflunomide should not be used by pregnant women or women of childbearing age who are not using reliable birth control. Do not take leflunomide if you are breast-feeding. If you plan to become pregnant, check with your health professional before stopping birth control and trying to become pregnant. He or she probably will prescribe a medication (cholestyramine) that will remove leflunomide from your body. Your health professional will then check to be sure that leflunomide is no longer detectable in your body.

People taking leflunomide will need regular monitoring of their liver function to check for signs of liver damage. Talk with your health professional before taking leflunomide if you have ever had liver, kidney, or immune system disease or a history of significant alcohol use.

Leflunomide may affect your immune system and your body's reaction to a live vaccination. Talk to your health professional before you receive a vaccination while taking leflunomide.

Because leflunomide is a relatively new medication, its long-term safety and effectiveness are not known.²

Complete the new medication information form (PDF)(What is a PDF document?) to help you understand this medication.

Citations

1. Osiri M, et al. (2005). Leflunomide for treatment of rheumatoid arthritis. Cochrane Database of Systematic Reviews (2). Oxford: Update Software.

2. Emery P, Suarez-Almazor M (2002). Rheumatoid arthritis. Clinical Evidence (10): 1454–1476.