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Important Safety Information


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. (see CONTRAINDICATIONS and WARNINGS.) Pregnancy must be avoided during ARAVA treatment or prior to the completion of the drug elimination procedure after ARAVA treatment.

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) >2xULN 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. (SEE WARNINGS – HEPATOTOXICITY).

Females of childbearing potential

Females on Arava® who wish to become pregnant

Drug elimination procedure for females

Without the drug elimination procedure, it may take up to 2 years for the active metabolite of leflunomide to reach plasma levels less than 0.02 mg/L due to individual variation in drug clearance.

Information for males

Available information does not suggest that Arava® would be associated with an increased risk of male-mediated fetal toxicity. To minimize any possible risk, men wishing to father a child should consider discontinuing use of Arava® and taking cholestyramine 8 grams 3 times daily for 11 days.

Additional safety information

Laboratory tests

Please see Full Prescribing Information, including boxed WARNING , for additional important information.