Generic Name and Formulations:
Icosapent ethyl 0.5g, 1g; soft gelatin caps.
Amarin Pharma Inc.
Indications for VASCEPA:
Adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500mg/dL) hypertriglyceridemia. Limitations of use: The effect of Vascepa on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. The effect of Vascepa on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Swallow whole. Do not crush, dissolve, or chew. 4 caps (0.5g) or 2 caps (1g) twice daily with food; maximum 4g per day.
Obtain baseline lipids before initiating therapy. Identify other causes of high triglycerides and manage appropriately (eg, diabetes, hypothyroidism, or alcohol intake). Hepatic impairment; monitor ALT and AST levels periodically during therapy. Fish and/or shellfish allergy. Pregnancy (Cat.C). Nursing mothers.
Monitor periodically with concomitant drugs that affect coagulation (eg, antiplatelet agents).
Hepatic. <99% protein bound.
Caps 0.5g—240; 1g—120