Risk of myopathy/rhabdomyolysis. Predisposing factors for myopathy including advanced age (≥65 yr), female gender, uncontrolled hypothyroidism, & renal impairment. Discontinue immediately if myopathy is diagnosed or suspected. Consider periodic CK determinations in patients starting treatment or whose dose is being increased especially to the 10/80 mg dose. Temporarily discontinue therapy a few days prior to elective major surgery & when any major medical or surgical condition supervenes. Asian patients. Perform liver function tests before treatment begins & thereafter; additional test prior to titration, 3 mth after titration to 10/80 mg dose, & periodically thereafter (eg, semiannually) for 1st yr of treatment. Patients who develop elevated serum transaminase levels. Discontinue treatment if transaminase levels rise to 3 x ULN & are persistent. Promptly interrupt therapy if serious liver injury &/or hyperbilirubinemia or jaundice occurs. Concomitant use w/ potent CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV PIs, boceprevir, telaprevir, nefazodone or drug containing cobicistat); gemfibrozil, cyclosporine or danazol; fusidic acid; amiodarone; Ca channel blockers (eg, verapamil, diltiazem, amlodipine); lomitapide; moderate CYP3A4 inhibitors; breast cancer resistant protein (BCRP) inhibitors (eg, elbasvir & grazoprevir); fenofibrate; fibrates; niacin (≥1 g/day); daptomycin; anticoagulants (eg, warfarin). Alcoholics &/or patients w/ past history of liver disease. Moderate or severe hepatic insufficiency. Lactation. Patients <10 yr or pre-menarchal girls. Elderly ≥65 yr.