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Arava
leflunomide
Black Box Warnings .
Embryo-Fetal Toxicity
contraindicated in pregnancy; teratogenicity and embryo-lethality occurred in animals at doses lower than human exposure level; exclude pregnancy prior to tx; advise females of reproductive potential to use effective contraception during tx and during drug elimination procedure after tx D/C; D/C tx and use drug elimination procedure if pt becomes pregnant
Hepatotoxicity
severe and fatal hepatic injury reported; contraindicated in severe hepatic impairment; pts w/ pre-existing hepatic dz or ALT >2x ULN should not receive tx; caution in pts receiving other potentially hepatotoxic agents; monitor LFTs at baseline, qmo x6mo, then q6-8wk; D/C tx if ALT >3x ULN, then if suspected leflunomide-induced hepatic injury start drug elimination procedure and monitor LFTs qwk until normalization; if hepatic injury not caused by leflunomide, may consider tx restart
Adult Dosing .
Dosage forms: TAB: 10 mg, 20 mg, 100 mg
rheumatoid arthritis
- [10-20 mg PO qd]
- Start: load 100 mg PO qd x3 days if low risk for leflunomide-assoc. hepatotoxicity or myelosuppression; Max: 20 mg/day for maint. tx; Alt: 10 mg PO qod; Info: may skip start dose if high risk for leflunomide-assoc. toxicity; give cholestyramine or activated charcoal for accelerated drug elimination after D/C
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- severe impairment: contraindicated; pre-existing hepatic dz or baseline ALT >2x ULN: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.