Vescap Capsule

Studies suggest that EPA reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles. Potential mechanisms of action include increased β-oxidation; inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT); decreased lipogenesis in the liver; and increased plasma lipoprotein lipase activity.

The mechanisms of action contributing to reduction of cardiovascular events with Icosapent Ethyl are not completely understood but are likely multi-factorial. Increased EPA lipid composition from carotid plaque specimens and increased circulating EPA/arachidonic acid ratio have been observed following EPA treatment. EPA inhibits platelet aggregation under some ex vivo conditions. However, the direct clinical meaning of individual findings is not clear.

Assess lipid levels before initiating therapy. Identify other causes of high triglyceride levels and manage as appropriate.

Patients should engage in appropriate nutritional intake and physical activity before receiving Icosapent Ethyl, which should continue during treatment.

The daily dose of Icosapent Ethyl is 4 grams per day taken as either-

• Four 0.5 gram capsules twice daily with food or
• Two 1 gram capsules twice daily with food.

Advise patients to swallow capsules whole. Do not break open, crush, dissolve, or chew Icosapent Ethyl.

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

Geriatric Use: Of the total number of patients in well-controlled clinical studies of Icosapent Ethyl, 45% were 65 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger groups. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

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

Increased Bleeding Risk with Anticoagulants and Antiplatelet Agents: Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. Monitor patients receiving Vescap and concomitant anticoagulants and/or antiplatelet agents for bleeding.

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

Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation.

Common adverse reactions in the hypertriglyceridemia trials (incidence ≥1% more frequent than placebo): arthralgia and oropharyngeal pain.

Lactation: The available data from published case reports and the pharmacovigilance database on the use of Icosapent Ethyl in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes.

Lactation: Published studies have detected omega-3 fatty acids, including EPA, in human milk. Lactating women receiving oral omega-3 fatty acids for supplementation have resulted in higher levels of omega-3 fatty acids in human milk. There are no data on the effects of omega-3 fatty acid ethyl esters on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Icosapent Ethyl and any potential adverse effects on the breastfed child from Icosapent Ethyl or from the underlying maternal condition.

Atrial Fibrillation/Flutter: Vescap was associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.

Potential for Allergic Reactions in Patients with Fish Allergy: Vescap contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fish. It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction to Vescap. Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions and advise them to discontinue Vescap and seek medical attention if any reactions occur.

Bleeding: Vescap was associated with an increased risk of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin.

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