CONTRAINDICATIONS AND WARNINGS
Pregnancy
Pregnancy must be excluded before the start of treatment with Arava. Arava is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception. Pregnancy must be avoided during Arava treatment or prior to the completion of the drug elimination procedure after Arava treatment.
Hepatotoxicity
Severe liver injury, including fatal liver failure, has been reported in some patients treated with Arava. Patients with pre-existing acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) >2×ULN before initiating treatment, should not be treated with Arava. Use caution when Arava is given with other potentially hepatotoxic drugs.
Monitoring of ALT levels is recommended at least monthly for six months after starting Arava, and thereafter every 6-8 weeks. If ALT elevation > 3 fold ULN occurs, interrupt Arava therapy while investigating the probable cause of the ALT elevation by close observation and additional tests. If likely leflunomide-induced, start cholestyramine washout and monitor liver tests weekly until normalized. If leflunomide-induced liver injury is unlikely because some other probable cause has been found, resumption of Arava therapy may be considered.
Arava (generic: leflunomide) is a prescription medication used to treat rheumatoid arthritis. This medication belongs to a group of drugs called DMARDs (disease modifying antirheumatic drugs) which work by suppressing the excessive activity of the immune system.
Arava comes in tablet form. It is usually taken once daily, with or without food.
Common side effects include diarrhea, nausea, vomiting, and headache.
Arava is a prescription medication used to treat rheumatoid arthritis.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Common side effects include:
- diarrhea
- vomiting
- heartburn
- headache
- dizziness
- weight loss
- back pain
- muscle pain or weakness
- pain, burning, numbness, or tingling in the hands or feet
- hair loss
- mouth sores
Tell your doctor if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of Arava. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.