Vascepa Generic Name & Formulations
Icosapent ethyl 0.5g, 1g; soft gelatin caps.
Caps 0.5g—240; 1g—120
Adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adults with elevated triglyceride (TG) levels (≥150mg/dL) and established cardiovascular disease (CVD), or diabetes plus ≥2 additional CVD risk factors. Adjunct to diet to reduce TG levels in adults with severe hypertriglyceridemia (≥500mg/dL).
Limitations of Use
The effect of Vascepa on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Vascepa Dosage and Administration
Swallow whole. 4 caps (0.5g) or 2 caps (1g) twice daily with food; max 4g/day.
Vascepa Boxed Warnings
Obtain baseline lipids before initiating therapy. Identify other causes of high triglycerides and manage appropriately (eg, diabetes, hypothyroidism, or alcohol intake). Increased risk of atrial fibrillation or atrial flutter requiring hospitalization. Bleeding events. Hepatic impairment; monitor ALT/AST levels periodically during therapy. Fish and/or shellfish allergy. Pregnancy. Nursing mothers.
Increased risk of bleeding with concomitant antithrombotics (eg, aspirin, clopidogrel, warfarin); monitor.
Vascepa Adverse Reactions
Musculoskeletal pain, peripheral edema, constipation, gout, atrial fibrillation, arthralgia, oropharyngeal pain.
Vascepa Clinical Trials
Vascepa Patient Counseling