HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciBemp safely and effectively. See full prescribing information for LuciBemp.

INDICATIONS AND USAGE

LuciBemp is an adenosine triphosphate-citrate lyase (ACL) inhibitor 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 LuciBemp on cardiovascular morbidity and mortality has not been determined.

DOSAGE AND ADMINISTRATION

Administer 180 mg orally once daily with or without food.

DOSAGE FORMS AND STRENGTHS

Tablets: 180 mg×90 tablets

CONTRAINDICATIONS

None .

WARNINGS AND PRECAUTIONS

•  Hyperuricemia: Elevations in serum uric acid have occurred. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.

•  Tendon Rupture: Tendon rupture has occurred. Discontinue LuciBemp at the first sign of tendon rupture.  Avoid LuciBemp in patients who have a history of tendon disorders or tendon rupture.

ADVERSE REACTIONS

Most common (incidence ≥ 2% and greater than placebo) adverse reactions are upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes.

DRUG INTERACTIONS

•  Simvastatin: Avoid concomitant use of LuciBemp with simvastatin greater than 20 mg.

•  Pravastatin: Avoid concomitant use of LuciBemp with pravastatin greater than 40mg.

USE IN SPECIFIC POPULATIONS

•  Pregnancy: Based on mechanism of action, may cause fetal harm.

•  Lactation: Breastfeeding is not recommended with LuciBemp.

Storage

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.