icosapent ethyl

REMS

Reduction in risk of MI, stroke, coronary revascularization, and unstable angina requiring hospitalization in patients with elevated triglyceride levels (≥150 mg/dL) and either established cardiovascular disease or type 2 diabetes with ≥2 additional risk factors for cardiovascular disease (as adjunctive therapy with maximally tolerated statin therapy).
Reduction of triglyceride levels in patients with severe hypertriglyeridemia (≥500 mg/dL) (as adjunctive therapy to diet).

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity.

Use Cautiously in:

Hypersensitivity to fish/shellfish;
Diabetes mellitus, hypothyroidism and excess alcohol intake may ↑ triglycerides and should be managed prior to treatment;
History of atrial fibrillation or atrial flutter;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness in children not established.

Adv. Reactions/Side Effects ⬆ ⬇

CV: atrial fibrillation/flutter

Hemat: bleeding

MS: arthralgia

Interactions ⬆ ⬇

Drug-drug:

Beta-blockers, thiazidesand estrogensmay ↑ triglycerides and should be discontinued/changed prior to treatment.
Anticoagulantsor antiplatelet agentsmay ↑ risk of bleeding.

Availability ⬆ ⬇

(Generic available)

Capsules: 500 mg; 1 g

Route/Dosage ⬆ ⬇

PO (Adults ): 2 g twice daily.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Decreases hepatic production of triglycerides and increases triglyceride clearance.

Therapeutic effects:

Reduction in triglyceride levels.
Reduction in risk of MI, stroke, coronary revascularization, and unstable angina requiring hospitalization.

Classifications ⬆ ⬇

Therapeutic Classification: lipid-lowering agents

Pharmacologic Classification: omega-3 acids

Pharmacokinetics ⬆ ⬇

Absorption: Converted during absorption to the active metabolite eicosapentaenoic acid (EPA), which is then absorbed in the small intestine and enters systemic circulation through the lymphatic system.

Distribution: Most EPA circulates incorporated into phospholipids, triglycerides and cholesteryl esters. Enters breast milk.

Metabolism/Excretion: Mostly metabolized by the liver, some metabolism results in liberation of acetyl Coenzyme A which the Krebs cycle uses to produce energy. No renal elimination.

Half-Life: 89 hr.

Time/Action Profile ⬆ ⬇

(EPA levels)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	5 hr	unknown

Patient/Family Teaching ⬆ ⬇

Instruct patient to take as directed. Take missed doses as soon as remembered unless almost time for next dose; do not double doses. Do not discontinue without consulting health care professional.
Advise patient to eat a well balanced, low fat and low cholesterol diet, exercise regularly, and avoid alcohol intake.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially anticoagulants.
Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected, or if breastfeeding.

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Indications ⬇