Icosapent ethyl

FDA label

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Renal Undefined

Hepatic Monitor ALT and AST periodically during therapy in patients with hepatic impairment.

Instructions

• Assess lipid levels before initiating therapy; identify and manage other causes of high triglycerides (e.g. diabetes, hypothyroidism, medications).
• Patients should begin appropriate nutritional intake and physical activity before starting, and continue both during treatment.
• Take with food.
• Swallow capsules whole — do not break open, crush, dissolve, or chew.

Cautions

• Atrial fibrillation/flutter requiring hospitalization — 3% vs 2% on placebo (HR 1.5); risk greater with a prior history of atrial fibrillation or flutter.
• Bleeding — 12% vs 10% on placebo, serious bleeding 3% vs 2%; risk greater with concomitant antithrombotics such as aspirin, clopidogrel, or warfarin.
• Potential allergic reactions in patients with fish or shellfish allergy — the EPA ethyl esters are obtained from fish oil; advise discontinuation and medical attention if reactions occur.

Adverse reactions

• Common (>=3% and >=1% more than placebo): musculoskeletal pain, peripheral edema, constipation, gout, atrial fibrillation.
• Hypertriglyceridemia trials (>=1% more than placebo): arthralgia, oropharyngeal pain.
• Postmarketing: diarrhea, increased blood triglycerides, abdominal discomfort, pain in the extremities.

Pregnancy Available human data are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Non-dose-related minor developmental findings in rats at exposures equivalent to the 4 g/day human dose; no clinically relevant effects in rabbits at 5x exposure.

Lactation Omega-3 fatty acids including EPA are present in human milk and rise with maternal supplementation. No data on effects on the breastfed infant or on milk production.