Do not use this drug in pregnancy. Pregnancy must be excluded prior to initiation of therapy. Reliable use of contraception in women of childbearing age should be ensured during therapy. Pregnancy must be avoided during and prior to completion of the drug elimination procedure after leflunomide treatment.
Leflunomide has been associated with liver toxicity. Monitoring of blood factors and liver function is recommended during therapy. The use of this drug in impaired liver function is not recommended.
Not recommended for use in patients with severe immune deficiency, bone marrow dysplasia, or with an uncontrolled infection.
DRUG INTERACTIONS
Methotrexate, rifampin, cholestyramine, charcoal, NSAIDs (nonsteroidal anti-inflammatory drugs), tolbutamide, other drugs known to cause liver toxicity.
FOOD INTERACTIONS
Unknown
HERBAL INTERACTIONS
Unknown
PREGNANCY AND BREAST-FEEDING CAUTIONS
FDA Pregnancy Risk Category X. Not known if this drug is excreted in breast milk. Breast-feeding is not recommended.
SPECIAL INFORMATION
This drug has a black box warning regarding the contraindication of pregnancy (see cautions).