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 ?
10-13) These include DHA+EPA combination products (omega-3-add ethyl esters [Lovaza, GlaxoSmithKline; generics], omega-3-acid ethyl esters A [Omtryg, Trygg Pharma, Inc], and omega-3-carboxylic acids [Epanova, AstraZeneca Pharmaceuticals LP]) and an EPA-only product, icosapent ethyl (Vascepa, Amarin Pharma Inc).
DHA+EPA combination products do not meet FDA definitions/codes for therapeutic equivalence to the EPA-only product icosapent ethyl and should therefore not be substituted.
3,4) Vascepa is a high-purity formulation containing icosapent ethyl, the ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA).
This edition has new drugs, including aclidinium bromide, felbamate, icosapent ethyl, linaclotide, peginesatide acetate, perampanel, rotigotine, and teriflunomide, and updated group monographs for antipsychotic agents, benzodiazepenes, calcium channel blocking agents, estrogens, macrolides, opioid analgesics, proton pump inhibitors, selective serotonin reuptake inhibitors, and serotonin 5-HT1 receptor agonists.
Icosapent ethyl is a purified formulation of ethyl eicosapentaenoic add (EPA), derived from fish oil, which was approved by the FDA in 2012 as monotherapy for treatment of severe hypertriglyceridemia (500 mg/dL or higher), based on the premise that lowering triglyceride levels reduces the risk of pancreatitis, not that it affects cardiovascular outcomes, according to the FDA.
Median triglyceride levels dropped with Vascepa Baseline Week 12 Icosapent ethyl 2 g/day (n = 234) 5.
Based on this evaluation, the company concluded that the majority of the potential suppliers lacked the technical skills and product quality infrastructure needed to consistently produce icosapent ethyl for AMR101 that is greater than 96% pure eicosapentaenoic acid (EPA).
The independent claim covers the use of icosapent ethyl, or EPA, including Vascepa, in lowering triglycerides through the daily administration of about 2500 mg to about 5000 mg of EPA, independent of DHA content, present in one or more capsules, effective to lower triglycerides in the subject by at least 25% without increasing LDL-C by more than 5%.
The notice of allowance is based on patent application 13/610,217, and covers the use of icosapent ethyl, or EPA, including Vascepa, to decrease triglycerides by the daily administration of around four capsules.
The claim covers the use of about 4 grams per day of highly pure icosapent ethyl, or EPA, including Vascepa, to lower triglycerides and LDL-C.