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Aubagio
teriflunomide
Black Box Warnings .
Hepatotoxicity
clinically significant and potentially life-threatening hepatic injury reported, incl. acute hepatic failure requiring transplant; contraindicated in pts w/ severe hepatic impairment; pts w/ pre-existing hepatic dz may have incr. risk of LFT elev. during tx; concomitant hepatotoxic agent use may incr. risk of severe hepatic injury; monitor LFTs, bilirubin w/in 6mo before tx start, then monitor ALT qmo x6mo after tx start; D/C tx and start accelerated elimination procedure if suspected drug-induced hepatic injury
Embryo-Fetal Toxicity
contraindicated in pregnancy and in females of reproductive potential w/o effective contraception; teratogenicity and embryolethality occurred in animals at exposures lower than in humans; 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
Adult Dosing .
Dosage forms: TAB: 7 mg, 14 mg
multiple sclerosis, relapsing forms
- [7-14 mg PO qd]
- Info: for pts w/ clinically isolated syndrome, relapsing-remitting dz, and active secondary progressive dz; give cholestyramine or activated charcoal for accelerated drug elimination after D/C
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- severe impairment: contraindicated
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.