Icosapent Ethyl

Icosapent ethyl capsules are indicated:

• as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL)hypertriglyceridemia.

• The effect of icosapent ethyl capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

Icosapent ethyl capsules are supplied as:

• 1 gram amber – coloured, oblong shaped soft gelatin capsules filled with colorless to light yellow liquid and bearing the designation “0958” on one side of the capsules.

The following important adverse reactions are described below and elsewhere in the labeling:

• Atrial Fibrillation or Atrial Flutter
  
  [see Warnings and Precautions (
  5.1 Atrial Fibrillation/Flutter

  Icosapent ethyl capsules are associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization. In a double-blind, placebo-controlled trial of 8,179 subjects, adjudicated atrial fibrillation or atrial flutter requiring hospitalization for 24 or more hours occurred in 127 (3%) patients treated with icosapent ethyl capsules compared to 84 (2%) patients receiving placebo [HR=1.5 (95% Cl 1.14, 1.98)]. 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
  
  [see Warnings and Precautions (
  5.2 Potential for Allergic Reactions in Patients with Fish Allergy

  Icosapent ethyl capsule 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 icosapent ethyl capsules. Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions to icosapent ethyl capsules and advise them to discontinue icosapent ethyl capsules and seek medical attention if any reactions occur.
  )]
• Bleeding
  
  [see Warnings and Precautions (
  5.3 Bleeding
  )]

Icosapent ethyl, a lipid-regulating agent, is supplied as a 1 gram liquid-filled soft gelatin capsule for oral administration.

Each icosapent ethyl capsule contains 1 gram of icosapent ethyl. Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22 H34 O2 and the molecular weight is 330.5. The chemical name for icosapent ethyl is (5Z, 8Z, 11Z, 14Z, 17Z)-Eicosa-5, 8, 11, 14, 17-Pentaenoic Acid Ethyl Ester with the following chemical structure:

Icosapent ethyl capsules contain the following inactive ingredients: dl-alpha tocopherol, gelatin, glycerin, sorbitol sorbitan solution, and purified water.

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.