NEXLETOL Film-coated tablet Ref.[9945] Active ingredients: Bempedoic acid

Source: FDA, National Drug Code (US)  Revision Year: 2020 

1. Indications and Usage

NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.

Limitations of Use

The effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined.

2. Dosage and Administration

2.1 Recommended Dosage

The recommended dosage of NEXLETOL, in combination with maximally tolerated statin therapy, is 180 mg administered orally once daily. NEXLETOL can be taken with or without food.

After initiation of NEXLETOL, analyze lipid levels within 8 to 12 weeks.

10. Overdosage

There is no clinical experience with NEXLETOL overdose. In the event of an overdosage, contact Poison Control (1-800-222-1222) for latest recommendations.

16.2. 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. Do not discard desiccant.

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