icosapent ethyl

(redirected from Vascepa)

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 ?
Previous FY18 guidance is unchanged, except that Amarin's recently completed financing has firmed up its commitment to increase awareness of Vascepa through additional promotional efforts beginning in Q2, including piloting multi-media awareness initiatives to assess the potential effectiveness of such communication for potential broader use after REDUCE-IT results, assuming study success.
Amarin acknowledges that the typical monthly cost of obtaining their product Vascepa is $200.
Vascepa was FDA-approved to treat adults with severe triglyceride levels, and Amarin was in the process of seeking approval for use in adults with slightly lower triglyceride levels.
Vascepa (a cholesterol medication) leads by the number of asserted patents.
M2 EQUITYBITES-September 1, 2016-Amarin randomizes all patients under REDUCE-IT cardiovascular outcomes study of Vascepa
Vascepa (icosapent ethyl; Amarin): Do minor differences between Vascepa and Epanova translate into clinical benefits for either brand?
The opinion came in response to an unusual lawsuit that Amarin filed in May that claimed the FDA was inhibiting its First Amendment rights to distribute information about Vascepa, a prescription fish oil pill that was approved to treat people with very high triglycerides, a type of fat in the blood that can lead to heart disease.
Approved by the Food a nd Drug Admini s tratio n (FDA) in 2012, Vascepa [R] (Amarin Pharma Inc.
Food and Drug Administration or FDA Endocrinologic and Metabolic Medication Advisory Panel has elected 9 to 2 against acceptance of Vascepa supplements for use as an adjunct to work out and dieting and along with a statin in the therapy of mature sufferers with high triglycerides with combined dyslipidemia and coronary heart disease or CHD or a CHD threat comparative in accordance with the details provided at the committee conference.
3bn) on Nasdaq, announced it had obtained clearance from the US Food and Drug Administration (FDA) for its Vascepa capsules.
In a flash note to clients Friday, Roth Capital Partners' analyst Joseph Pantginis says Thursday's FDA approval for Amarin Corporation's Vascepa bodes well for Neptune Technologies & Bioressources' underlying and growing core NKO business as well as the pharmaceutical opportunity with Acasti's CaPre, a Reuters report said.
Lynch served as Chairman and Chief Executive Officer of Amarin Corporation from December 2007 through December 2009 during which time he re-purposed and refinanced the company toward the development of Vascepa for hypertriglyceridemia and dislipidemia.