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Label Changes for:

Arava (leflunomide) oral tablets, 10mg, 20mg, 100mg

April 2009

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Summary View


Brand (Generic) Name

Sections Modified

Arava (leflunomide) oral tablets, 10mg, 20mg, 100mg

Label approved 04/03/2009 is not available on Drugs@FDA


  • Tuberculosis Reactivation
    • Prior to initiating immunomodulatory therapies, including Arava, patients should be screened...
    • Arava has not been studied in patients with a positive tuberculosis screen...
    • Patients testing positive in tuberculosis screening should be treated by standard medical practice prior to therapy with Arava.
  • Blood Pressure Monitoring
    • Blood pressure should be checked before start of leflunomide treatment and periodically thereafter.