icosapent ethyl

Therapeutic Classification: lipid-lowering agents

Pharmacologic Classification: omega-3 acids

Indications ⬆ ⬇

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).

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.

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

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.

Route/Dosage ⬆ ⬇

PO (Adults ): 2 g twice daily.

Availability ⬆ ⬇

(Generic available)

Capsules: 500 mg; 1 g

Assessment ⬆ ⬇

Obtain a dietary history, especially with regard to fat consumption.
Assess for allergy to fish and shellfish.
Monitor patients taking concurrent antithrombotic medications (aspirin, clopidogrel, warfarin) for bleeding.

Lab Test Considerations:

Monitor lipid and triglyceride levels prior to and periodically during therapy.
- Monitor ALT and AST levels periodically in patients with liver impairment.

Implementation ⬆ ⬇

PO: Administer 2 capsules twice daily with food. DNC: Swallow capsules whole; do not open, crush, dissolve, or chew.

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.

Evaluation/Desired Outcomes ⬆ ⬇

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

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

52937- Amarin Pharma Inc.
- 52937-001- Vascepa
  - 52937-001-04- 4 CAPSULE in 1 BOTTLE (52937-001-04)

52937- Amarin Pharma Inc.
- 52937-001- Vascepa
  - 52937-001-20- 120 CAPSULE in 1 BOTTLE (52937-001-20)

52937- Amarin Pharma Inc.
- 52937-001- Vascepa
  - 52937-001-21- 120 CAPSULE in 1 BOTTLE (52937-001-21)

52937- Amarin Pharma Inc.
- 52937-003- Vascepa
  - 52937-003-16- 1 BLISTER PACK in 1 CARTON (52937-003-16) > 16 CAPSULE in 1 BLISTER PACK

52937- Amarin Pharma Inc.
- 52937-003- Vascepa
  - 52937-003-40- 240 CAPSULE in 1 BOTTLE (52937-003-40)

52937- Amarin Pharma Inc.
- 52937-101- Vascepa
  - 52937-101-08- 1 BLISTER PACK in 1 CARTON (52937-101-08) > 8 CAPSULE in 1 BLISTER PACK

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Pronunciation ⬇

Classifications ⬆ ⬇