Bempedoic acid

LuciBemp (Bempedoic acid) 180mg

EACH LUCIBEMP TABLET CONTAINS: Bempedoic acid ………………… 180 mg

INDICATION:

LuciBemp is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adult patients with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C.

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

DOSAGE AND USE:

• Recommended dosage: 180 mg orally once daily.
• Can be taken with or without food.
• After initiation, monitor lipid levels within 8 to 12 weeks.
• Tablets should be swallowed whole and not crushed or chewed.

CONTRAINDICATIONS:

• None

WARNINGS AND PRECAUTIONS:

• Hyperuricemia: May increase uric acid levels; monitor and manage appropriately.
• Tendon rupture: Risk increased, especially in patients >60 years, those on corticosteroids or fluoroquinolones, renal failure, or prior tendon disorders. Discontinue if tendon rupture occurs.
• Advise patients to report joint pain, swelling, or inflammation.

ADVERSE REACTIONS:

Common adverse reactions (≥2% and greater than placebo):

• Upper respiratory tract infection
• Muscle spasms
• Back pain
• Abdominal pain / discomfort
• Bronchitis
• Pain in extremity
• Anemia
• Elevated liver enzymes

DRUG INTERACTIONS:

• Simvastatin: Avoid doses >20 mg
• Pravastatin: Avoid doses >40 mg
• Increased risk of statin-related adverse effects when co-administered

USE IN SPECIAL POPULATIONS:

• Pregnancy: Discontinue when pregnancy is recognized
• Lactation: Not recommended
• Renal impairment: No dose adjustment required
• Hepatic impairment: No adjustment for mild/moderate; limited data in severe impairment
• Pediatric use: Safety and effectiveness not established

STORAGE:

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Keep out of reach of children.

PACKAGING:

Available in packs of 90 tablets.

Manufactured and Marketed by:

LUCIUS PHARMACEUTICALS (LAO) CO., LTD

No. 26, Thongmang Village, Xaythany District, Vientiane Capital, Laos