Contraindicated in pregnant women and women of childbearing potential who are not using a reliable form of contraception. (See Fetal/Neonatal Morbidity and Mortality and also see Contraindications under Cautions.)
Pregnancy must be excluded prior to initiation of therapy.
Pregnancy must be avoided while the woman is receiving leflunomide and prior to completion of the drug elimination procedure following discontinuance of the drug. (See Drug Elimination Procedures Following Leflunomide Discontinuance under Dosage and Administration.)
Hepatotoxicity
Severe liver injury, including fatal liver failure, reported.
Do not use in patients with preexisting liver disease or baseline ALT >2 times ULN; use with caution in patients receiving other potentially hepatotoxic drugs. (See Hepatic Effects under Cautions.)
Regular monitoring of ALT during therapy required; ALT >3 times ULN warrants interruption of therapy while cause is investigated. (See Hepatic Effects under Cautions.)
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