Jane S. Ricciuti, RPh, MS


January 29, 2004

In This Article

Rheumatologic Agents


Manufacturer: Aventis Pharmaceuticals

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 10/03)

Warnings: The labeling for Arava (leflunomide) has been updated to include postmarketing reports of serious hepatic injury.

  • Hepatotoxicity

    • Rare cases of severe liver injury, including cases with fatal outcome, have been reported during treatment with leflunomide. Most cases of severe liver injury occur within 6 months of therapy and in a setting of multiple risk factors for hepatotoxicity (liver disease, other hepatotoxins).

Complete monitoring guidelines are included in the revised labeling.

Arava (leflunomide) Labeling

Medscape DrugInfo

Arava (leflunomide)