Icosapent Ethyl capsules are indicated as an adjunct to maximally tolerated statin therapy to lower the risk of cardiovascular events, including myocardial infarction, stroke, coronary revascularization, and hospitalization due to unstable angina in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) who have:

• Established cardiovascular disease, or
• Diabetes mellitus with two or more additional cardiovascular risk factors.

It is also used as an adjunct to dietary management to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL).

Limitations of Use: The effectiveness of Icosapent Ethyl in reducing the risk of pancreatitis in patients with severe hypertriglyceridemia has not been established.

Icosapent Ethyl is the ethyl ester form of the omega-3 fatty acid eicosapentaenoic acid (EPA). It works by decreasing hepatic synthesis and/or secretion of very low-density lipoprotein triglycerides (VLDL-TG) and enhancing the clearance of triglycerides from circulating VLDL particles. Its mechanisms include increased beta-oxidation, inhibition of triglyceride synthesis enzymes such as DGAT, reduced hepatic lipogenesis, and increased activity of plasma lipoprotein lipase.

The daily dose of Vescap is 4 grams per day taken as Two 1 gm capsules twice daily with food. Advise patients to swallow capsules whole. Do not break open, crush, dissolve, or chew Vescap.

Renal Impairment: Icosapent ethyl has not been studied in patients with renal impairment.

Hepatic Impairment: In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be monitored periodically during therapy with Icosapent ethyl.

Pediatric use: Safety and effectiveness in pediatric patients have not been established.

Geriatric use: Icosapent ethyl is safe and effective in geriatric patients.

Increased bleeding risk with anticoagulants and antiplatelet agents: Omega-3 fatty acids, including Icosapent Ethyl, may prolong bleeding time. Patients receiving this medication along with anticoagulants or antiplatelet agents should be monitored for signs of bleeding.

Icosapent Ethyl is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to Icosapent Ethyl or any of its components.

Common adverse reactions observed include musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation. In patients with hypertriglyceridemia, joint pain and oropharyngeal discomfort have also been reported.

Use during pregnancy only if the expected benefit outweighs the potential risk to the fetus. Omega-3 fatty acids, including EPA, are excreted in human milk. Due to possible adverse effects on the breastfed infant, a decision should be made whether to discontinue breastfeeding or discontinue the drug, considering its importance to the mother.

Atrial fibrillation/flutter: Icosapent Ethyl may increase the risk of atrial fibrillation or flutter requiring hospitalization, especially in patients with a history of these conditions.

Allergic reactions (fish allergy): Since Icosapent Ethyl is derived from fish oil, patients with known fish or shellfish allergy may have an increased risk of hypersensitivity reactions. Discontinue use and seek medical advice if allergic symptoms occur.

Bleeding risk: There is an increased risk of bleeding, particularly in patients taking antithrombotic medications such as aspirin, clopidogrel, or warfarin.

Anti-anginal & lipid lowering drugs

Store below 25°C, protected from light. Keep out of reach of children.