Icosapent ethyl

VASCEPA ® (icosapent ethyl) is indicated: as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease. as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Limitations of Use: The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

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 VASCEPA (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 VASCEPA, which should continue during treatment. The daily dose of VASCEPA 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 VASCEPA.

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

Atrial Fibrillation/Flutter: VASCEPA 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: VASCEPA 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 VASCEPA. Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions and advise them to discontinue VASCEPA and seek medical attention if any reactions occur.

The following important adverse reactions are described below and elsewhere in the labeling: Atrial Fibrillation or Atrial Flutter Potential for Allergic Reactions in Patients with Fish Allergy Bleeding 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.

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 VASCEPA and concomitant anticoagulants and/or antiplatelet agents for bleeding.

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