Brand Name: Arava®
Active Ingredient: leflunomide
Strength(s): 10mg, 20mg, and 100mg
Dosage Form(s): Tablets
Company Name: Aventis Pharmaceuticals
Availability: Prescription only
Date Approved by FDA: September 10, 1998

What is Arava used for?

Arava is used to treat active rheumatoid arthritis in adults to reduce signs and symptoms,  slow down damage to joints, and improve physical function.  Arava is not indicated in children or adolescents with juvenile rheumatoid arthritis.

Who should not take Arava?

You must not take Arava if you are pregnant or a woman of childbearing age not using reliable contraception.

Special Warning(s) with Arava:

For Women:

• You must not take Arava if you are pregnant or a woman of childbearing age not using reliable contraception because in animal studies Arava has been shown to cause birth defects to the fetus.
• You must avoid becoming pregnant while being treated with Arava. If you suspect or find out that you are pregnant while taking Arava, call your health care provider right away.
• After stopping Arava treatment, you must complete the drug elimination procedure before becoming pregnant because Arava stays in the body a long time.
• You should not breast-feed if you are taking Arava.

For Men:

• If there is any possibility your partner could become pregnant, you should stop Arava treatment and go through the drug elimination procedure prescribed by your doctor.

For All Patients:

·         Rare cases of severe liver injury, including death, have been reported by patients taking Arava. Your doctor will conduct liver tests before you start taking Arava and will check your liver's response to Arava monthly for the first six months and then, if unchanged, every 6 to 8 weeks thereafter.

·         Interstitial lung disease (an inflammation of lung tissue) has been reported in patients taking Arava.  If you develop new or worsening symptoms such as cough or trouble breathing, with or without a fever, notify your health care provider immediately.

General Precautions with Arava:

If you have the following conditions or if you are being treated with medications that can be harmful to your liver, Arava may not be right for you:

• liver disease including hepatitis B or hepatitis C
• kidney problems
• severe immune system disorders, bone marrow disorders or uncontrolled infection.

What are some possible side effects of Arava? (This is NOT a complete list of side effects reported with Arava. Your health care provider can discuss with you a more complete list of side effects.)  

• diarrhea
• elevated liver enzymes
• hair loss
• skin rash
• mouth sores
• unusual tiredness
• abdominal pain

• Date created:  February 17, 1999, updated:  July 25, 2005