Black Box Warning
WARNING: HEPATOTOXICITY and EMBRYOFETAL TOXICITY • Hepatotoxicity: Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with teriflunomide tablets in the postmarketing setting [see Warnings and Precautions (5.1) ] . Concomitant use of teriflunomide tablets with other hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of teriflunomide tablets therapy. Monitor ALT levels at least monthly for six months after starting teriflunomide tablets [see Warnings and Precautions (5.1) ]. If drug induced liver injury is suspected, discontinue teriflunomide tablets and start an accelerated elimination procedure with cholestyramine or charcoal [see Warnings and Precautions (5.3) ] . Teriflunomide tablets are contraindicated in patients with severe hepatic impairment [see Contraindications (4) ] . Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking teriflunomide tablets. • Embryofetal Toxicity: Teriflunomide tablets are contraindicated for use in pregnant women and in females of reproductive potential who are not using effective contraception because of the potential for fetal harm. Teratogenicity and embryolethality occurred in animals at plasma teriflunomide exposures lower than that in humans. Exclude pregnancy before the start of treatment with teriflunomide tablets in females of reproductive potential. Advise females of reproductive potential to use effective contraception during teriflunomide tablets treatment and during an accelerated drug elimination procedure after teriflunomide tablets treatment. Stop teriflunomide tablets and use an accelerated drug elimination procedure if the patient becomes pregnant [see Contraindications (4) , Warnings and Precautions (5.2 , 5.3) , Use in Specific Populations (8.1 , 8.3) , an
What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Aubagio.