VASCEPA Capsule Ref.[27435] Active ingredients: Eicosapentaenoic acid

Source: FDA, National Drug Code (US)  Revision Year: 2020 

1. Indications and Usage

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.

2. Dosage and Administration

2.1 Prior to Initiation of VASCEPA

  • Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) 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 with VASCEPA.

2.2 Dosage and Administration

  • The daily dose of VASCEPA is 4 grams per day taken as either:
    • four 0.5 gram capsules twice daily with food; or as
    • two 1 gram capsules twice daily with food.
  • Advise patients to swallow VASCEPA capsules whole. Do not break open, crush, dissolve, or chew VASCEPA.

16.2. Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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