icosapent ethyl

icosapent ethyl

(eye-koe-sa pent eth-il) ,

Vascepa

(trade name)

Classification

Therapeutic: lipid lowering agents
Pharmacologic: omega 3 acids
Pregnancy Category: C

Indications

Adjunct in the reduction of triglycerides in adult patients with hypertriglyeridemia (≥500 mg/dL); used in conjuction with diet/exercise.

Action

Decreases hepatic production of triglycerides and increases triglyceride clearance.

Therapeutic effects

Reduction in triglycerides as part of a program to reduce cardiovascular morbidity and mortality.

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 and 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)

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Contraindications/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; Obstetric: Use during pregnancy only if potential maternal benefit outweighs potential risk to fetus; Lactation: Use cautiously during lactation; Pediatric: Safe and effective use in children has not been established.

Adverse Reactions/Side Effects

Hematologic

  • prolonged bleeding time

Musculoskeletal

  • arthralgia

Interactions

Drug-Drug interaction

Beta-blockers, thiazides and estrogens may ↑ triglycerides and should be discontinued/changed prior to treatment. May ↑ risk of bleeding with anticoagulants or antiplatelet agents.

Route/Dosage

Oral (Adults) 2 g twice daily.

Availability

Capsules: 1 g

Nursing implications

Nursing assessment

  • Obtain a dietary history, especially with regard to fat consumption.
  • Assess for allergy to fish and shellfish.
  • 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.

Potential Nursing Diagnoses

Noncompliance (Patient/Family Teaching)

Implementation

  • Oral: Administer 2 capsules twice daily with food. 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 female patient to notify health care professional if pregnancy is planned or suspected, or if breastfeeding.

Evaluation/Desired Outcomes

  • Decrease in triglyceride levels.
References in periodicals archive ?
Fish oil supplements (particularly icosapent ethyl) are recommended, in combination with a statin, for patients with hypertriglyceridaemia despite statin treatment.
Over five years, 4 grams a day of the fish oil icosapent ethyl reduced both first and subsequent heart attacks and strokes as well as CVD deaths by 25%.
Vascepa (icosapent ethyl) is Amarin's first FDA-approved drug and is available by prescription in the United States, Lebanon and the United Arab Emirates.
The omega-3 compound icosapent ethyl simultaneously reduces triglycerides and inflammation, and it reduces atherosclerotic events.
The Reduction of Cardiovascular Events with Icosapent Ethyl Intervention Trial (REDUCE-IT) enrolled 8,179 patients (median age, 64 years) with cardiovascular disease or with diabetes and other cardiovascular disease risk factors, who had been receiving statin therapy and who had a fasting triglyceride level of 135-499 mg/dl and an LDL-cholesterol level of 41-100 mg/dl.
The American Diabetes Association, or ADA, announced that it has issued updates to the 2019 Standards of Medical Care in Diabetes, in annotations as the Living Standards of Care, that it said are "focused on improving cardiovascular and renal health in people with diabetes." Within the March 27 Living Standards of Care updates, Section 10 was updated based on the outcome of Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial, or REDUCE-IT, which determined the addition of icosapent ethyl to statin therapy for patients with high triglyceride levels reduced cardiovascular events.
About half of the participants received EPA via a high-dose--4 grams (g) per day--of icosapent ethyl (Vascepa), a fish-oil based prescription supplement.
In REDUCE-IT, icosapent ethyl, another fish-derived product, reduced major cardiovascular events by 25% in a study of more than 8,000 high-cardiovascular-risk patients with elevated triglycerides.
According to the company, Vascepa (icosapent ethyl) capsules are a single-molecule prescription product consisting of 1 gram of the omega-3 acid commonly known as EPA in ethyl-ester form.
* Vascepa (icosapent ethyl; Amarin): Do minor differences between Vascepa and Epanova translate into clinical benefits for either brand?
may promote to health care professionals certain uses of its lead product--Vascepa (icosapent ethyl) capsules--that are not covered by current Food and Drug Administration-approved labeling for the drug so long as the promotion is truthful and not misleading.
Approved by the Food a nd Drug Admini s tratio n (FDA) in 2012, Vascepa [R] (Amarin Pharma Inc.; see inset for indication) is an appropriate choice either alone or in combination with a statin for reducing triglycerides in adult patients with triglycerides [greater than or equal to]500 mg/dL.(3,4) Vascepa is a high-purity formulation containing icosapent ethyl, the ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA).