BEMPEDIS

COMPOSITION
Bempedoic acid……………………….…….180mg

INDICATION
• BEMPEDIS 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 BEMPEDIS on cardiovascular morbidity and mortality has not been determined.

PACKAGING: 30 tablets per bottle.

Reg No: 03 L 1308/25
Download BEMPEDIS Drug Registration Certificate

Brand name: BEMPEDIS


Composition:
Each tablet contains:
Bempedoic acid……………………….…….180mg


Indications:
• BEMPEDIS 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 BEMPEDIS on cardiovascular morbidity and mortality has not been determined.


Dosage: Administer 180 mg orally once daily with or without food.


Contraindications: None.


Warnings:
• 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 BEMPEDIS at the first sign of tendon rupture. Avoid BEMPEDIS in patients who have a history of tendon disorders or tendon rupture.


Adverse Effects: 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.


Dosage form: White tablet.


Expiry date: 24 months from the date of manufacture.


Packaging: 30 tablets per bottle.


Storage:
• Store at 20°C to 25°C; excursions permitted to 15°C to 30°C.
• Store and dispense in the original package protected from extreme heat and humidity. Do not discard desiccant.


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