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 reduction of LDL-C levels.

Bempedoic Acid is an inhibitor of adenosine triphosphate-citrate lyase (ACL), which reduces low-density lipoprotein cholesterol (LDL-C) by inhibiting cholesterol synthesis in the liver. ACL acts upstream of HMG-CoA reductase in the cholesterol biosynthesis pathway. Bempedoic acid and its active metabolite (ESP15228) require activation by coenzyme A (CoA) through very long-chain acyl-CoA synthetase 1 (ACSVL1) to form ETC-1002-CoA and ESP15228-CoA. ACSVL1 is primarily expressed in the liver. Inhibition of ACL results in reduced cholesterol synthesis and increased expression of LDL receptors, leading to decreased LDL-C levels in the blood. Ezetimibe is a potent and selective inhibitor of cholesterol absorption, reducing the delivery of cholesterol to the liver and promoting increased LDL receptor activity, thereby further lowering serum LDL-C levels.

Administer Bempedoic Acid 180 mg & Ezetimibe 10 mg tablet orally once daily with or without food. The safety and effectiveness of this tablet have not been established in pediatric patients.

Simvastatin: Concomitant use of Bempedoic Acid & Ezetimibe with simvastatin doses greater than 20 mg should be avoided.
Pravastatin: Concomitant use of Bempedoic Acid & Ezetimibe with pravastatin doses greater than 40 mg should be avoided.

This medication is contraindicated in patients with known hypersensitivity to ezetimibe. Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria have been reported.

• Upper respiratory tract infection
• Muscle spasms
• Hyperuricemia
• Back pain
• Abdominal pain or discomfort
• Bronchitis
• Pain in extremities
• Anemia
• Elevated liver enzymes

 Discontinue Bempedoic Acid & Ezetimibe once pregnancy is detected unless the potential benefit outweighs the risk to the fetus. There are no adequate data on the use of Bempedoic Acid & Ezetimibe in pregnant women to assess drug-related risks such as major birth defects, miscarriage, or adverse maternal or fetal outcomes. Information regarding the presence of these drugs in human or animal milk, their effects on the breastfed infant, or their impact on milk production is not available. Breastfeeding is not recommended during treatment with Bempedoic Acid & Ezetimibe.

Elevated serum uric acid levels have been observed. Uric acid levels should be monitored periodically as clinically indicated. Patients should be observed for signs and symptoms of hyperuricemia, and appropriate treatment with urate-lowering agents should be initiated if needed. Cases of tendon rupture have been reported. Discontinue Bempedoic Acid & Ezetimibe at the first sign of tendon rupture. Avoid use in patients with a history of tendon disorders or tendon rupture.

Other Anti-anginal & Anti-ischaemic drugs

Do not store above 30°C. Keep protected from light and out of reach of children.