October 9, 2015
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There have been reports of chronic overdose in patients taking ARAVA at daily dose up to five times the recommended daily dose and reports of acute overdose in adults and children. Adverse events were consistent with the safety profile for ARAVA [See ADVERSE REACTIONS]. The most frequent adverse events observed were diarrhea, abdominal pain, leukopenia, anemia and elevated liver function tests.

In the event of a significant overdose or toxicity, perform an accelerated drug elimination procedure to accelerate elimination [see WARNINGS AND PRECAUTIONS].

Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that teriflunomide, the primary metabolite of leflunomide, is not dialyzable [See CLINICAL PHARMACOLOGY].


ARAVA is contraindicated in:

  • Pregnant women. Arava may cause fetal harm. If a woman becomes pregnant while taking this drug, stop ARAVA, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].
  • Patients with severe hepatic impairment [see WARNINGS AND PRECAUTIONS].
  • Patients with known hypersensitivity to leflunomide or any of the other components of ARAVA. Known reactions include anaphylaxis [see ADVERSE REACTIONS].
  • Patients being treated with teriflunomide [see DRUG INTERACTIONS].

Last reviewed on RxList: 9/15/2015
This monograph has been modified to include the generic and brand name in many instances.


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