Discontinue use if seizure or signs or symptoms of SJS/TEN develop. Evaluate for fracture & fall risk. Monitor for signs & symptoms of ischemic heart disease & cerebrovascular disorders. Severe renal impairment or ESRD (eGFR ≤29 mL/min/1.73 m2). Severe hepatic impairment (Child-Pugh class C). Patients w/ female partners of reproductive potential should use a condom along another highly effective contraception during treatment & for 3 mth after last dose. May impair fertility in males of reproductive potential. Lactation. Childn ≤17 yr.
Steady-state Cmax & AUC may be increased w/ gemfibrozil & ketoconazole. Steady-state Cmax & AUC may be decreased w/ rifampin. Lowered exposure of CYP3A4, CYP2C19, or CYP2C9 substrates; UDP-glucuronosyl transferase substrates; P-gp, BCRP, or OATP1B1 substrates. Monitor INR in concomitant use w/ warfarin.
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