Icosapent

DEA Class; Rx

Common Brand Names; Vascepa

Indicated for use as an adjunct to diet for the treatment of severe hypertriglyceridemia (500 mg/dL or more).

Hypersensitivity to drug or any of its components

• Bleeding event (12%)
• Musculoskeletal pain (≥3%)
• Peripheral edema (≥3%)
• Constipation (≥3%)
• Gout (≥3%)
• Atrial fibrillation or flutter (3%)
• Serious bleeding event (3%)
• Diarrhea
• Blood TG increased
• Abdominal discomfort
• Pain in extremities

Associated with increased risk of atrial fibrillation or atrial flutter requiring hospitalization compared with placebo (3% vs 2%)

Contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fish; unknown whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction

Use associated with increased risk of bleeding; incidence is greater if taking concomitant antithrombotic medications (eg, aspirin, clopidogrel, or warfarin)

Available data from published case reports and the pharmacovigilance database on the use in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes

Lactation

Published studies have detected omega-3 fatty acids, including EPA, in human milk

Lactating women receiving oral omega-3 fatty acids for supplementation have resulted in higher levels of omega-3 fatty acids in human milk

There are no data on the effects of omega-3 fatty acid ethyl esters on the breastfed infant or on milk production

Consider developmental and health benefits of breastfeeding along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition