bempedoic acid 180 mg ezetimibe 10 mg NEXLIZET
1 INDICATIONS AND USAGE NEXLIZET, a combination of bempedoic acid and ezetimibe, is indicated: As an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). The bempedoic acid component of NEXLIZET is indicated: To reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with: established cardiovascular disease (CVD), or a high risk for a CVD event but without established CVD. NEXLIZET, a combination of bempedoic acid, an adenosine triphosphate citrate lyase (ACL) inhibitor, and ezetimibe, a dietary cholesterol absorption inhibitor, is indicated: As an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). ( 1 ) The bempedoic acid component of NEXLIZET is indicated: To reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with: established cardiovascular disease (CVD), or a high risk for a CVD event but without established CVD. ( 1 )
esperion therapeutics, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied NEXLIZET tablets are supplied as follows: Tablet Strength Description Package Configuration NDC No. 180 mg of bempedoic acid and 10 mg of ezetimibe blue, oval shaped, debossed with "818" on one side and "ESP" on the other side Bottle of 30 tablets with child-resistant cap 72426-818-03 Bottle of 90 tablets with child-resistant cap 72426-818-09 Storage and Handling Store at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature] . Store and dispense in the original package protected from extreme heat and humidity. Do not discard desiccant.
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