Adjunct to diet & maximally tolerated statin therapy for the treatment of adults w/ heterozygous familial hypercholesterolemia or established atherosclerotic CV disease who require additional lowering of LDL-C.
Effect on CV morbidity & mortality has not been determined. Administer either at least 2 hr before or at least 4 hr after bile acid sequestrants. Risk of hyperuricemia & gout. Increased risk of tendon rupture or injury, which may occur more frequently in patients >60 yr, patients taking corticosteroid or fluoroquinolone drugs, patients w/ renal failure, & patients w/ previous tendon disorders. Immediately discontinue treatment if tendon rupture occurs. Limited experience in patients w/ severe renal impairment (eGFR <30 mL/min/1.73 m2). Not studied in patients w/ ESRD receiving dialysis. Not recommended in patients w/ moderate or severe hepatic impairment (Child-Pugh B or C). Discontinue in case of pregnancy unless benefits of therapy outweigh potential risks to fetus. Breastfeeding is not recommended during treatment. Safety & effectiveness have not been established in ped patients.
C10BA10 - bempedoic acid and ezetimibe ; Belongs to the class of HMG CoA reductase inhibitors in combination with other lipid modifying agents. Used in the treatment of hyperlipidemia.
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