Contraindicated in Pregnancy
- Pregnancy must be excluded prior to initiation of therapy with leflunomide.
- Leflunomide is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception.
- Pregnancy must be avoided during and prior to completion of the drug elimination procedure after leflunomide treatment.
- Severe liver injury, inculding fatal liver failure, has been reported in some patients treated with leflunomide.
- Patients with pre-existing acute or chronic liver disease should not receive leflunomide.
- Patients with elevated serum alanine aminotransferase (ALT) greater than two times the upper limit of normal before initiating treatment should not receive leflunomide.
- Use caution when leflunomide is given with other potentially hepatotoxic drugs.
- Monitoring of ALT levels is recommended at least monthly for 6 months after starting leflunomide and thereafter every 6 to 8 weeeks. If the ALT rises to greater than 3 times the upper limit of normal while the patient is on leflunomide – leflunomide should be stopped while investigating the probable cause of the ALT elevation by close observation and additional tests.
- If likely that ALT elevations are leflunomide-induced, start cholestryamine washout and monitor liver tests weekly until normalized.
- If leflunomide-induved liver injury is unlikely because some other probable cause has been found, resumption of leflunomide therapy may be considered.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Exclude pregnancy prior to initiation of therapy
- See product insert for specific instructions on patient counseling and testing
Patient Counseling Information
Updated January 2018