omega-3-acid ethyl esters

omega-3-acid ethyl esters

Lovaza

Pharmacologic class: Combination ethyl esters of omega-3 fatty acids, principally eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)

Therapeutic class: Lipid-regulating agent

Pregnancy risk category C

Action

Unclear. May include inhibition of acyl-CoA: 1,2-diacylglycerol acyltransferase, increased mitochondrial and peroxisomal β-oxidation in the liver, decreased lipogenesis in the liver, and increased plasma lipoprotein lipase activity; may reduce synthesis of triglycerides in the liver because EPA and DHA are poor substrates for the enzymes responsible for triglyceride synthesis, and EPA and DHA inhibit esterification of other fatty acids.

Availability

Capsules: 1 g

Indications and dosages

Adjunct to diet to reduce triglyceride levels in patients with severe (500 mg/dl or greater) hypertriglyceridemia

Adults: 4 g P.O. daily as a single 4-g dose or as 2-g dose P.O. b.i.d.

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:
• hepatic impairment
• hypersensitivity to fish or shellfish
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

• Administer capsules whole with meals.
• Assess triglyceride levels carefully before starting therapy, and identify other causes (such as diabetes mellitus, hypothyroidism, or drugs) of high triglyceride levels; manage as appropriate.
• Ensure patient is on appropriate lipid-lowering diet before starting drug.

Adverse reactions

GI: vomiting, constipation, GI disorder, eructation, dyspepsia

Hepatic: increased liver enzyme levels

Skin: pruritus, rash

Other: taste perversion

Interactions

Drug-drug.Anticoagulants, other drugs affecting coagulation (such as aspirin, NSAIDs): prolonged bleeding time

Drug-diagnostic tests.ALT, AST, LDL-C: increased levels

Patient monitoring

• Monitor hepatic function tests in patients with hepatic impairment.
• Monitor LDL-C and triglyceride levels periodically.

Patient teaching

• Tell patient to take capsules whole with meals and not to break open, crush, dissolve, or chew them.
• Instruct patient to tell prescriber if he's allergic to fish.
• Advise patient to maintain lipid-lowering diet.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

omega-3-acid ethyl esters

(ohme-ga three as-id eth-il es-ters) ,

Lovaza

(trade name)

Classification

Therapeutic: lipid lowering agents
Pharmacologic: fatty acids
Pregnancy Category: C

Indications

Hypertriglyceridemia (triglycerides ≥500 mmg/dL) in adults; used with specific diet.

Action

Inhibits synthesis of triglycerides.

Therapeutic effects

Lowering of triglycerides.

Pharmacokinetics

Absorption: Well absorbed.
Distribution: Unknown.
Metabolism and Excretion: Incorporated into phospholipids.
Half-life: Unknown.

Time/action profile (lowering of triglycerides)

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Contraindications/Precautions

Contraindicated in: Hypersensitivity.
Use Cautiously in: Allergy/hypersensitivity to fish; Obstetric / Lactation: Pregnancy or lactation; Pediatric: Safety not established.

Adverse Reactions/Side Effects

Gastrointestinal

  • altered taste
  • eructation

Dermatologic

  • rash

Interactions

Drug-Drug interaction

May ↑ risk of bleeding with aspirin or warfarin.

Route/Dosage

Oral (Adults) 4 g/day; may be given as a single dose or 2 g twice daily.

Availability

Gelatin capsules (oil-filled): 1 g Cost: $196.69 / 100

Nursing implications

Nursing assessment

  • Obtain a diet history, especially with regard to fat consumption.
  • Lab Test Considerations: Monitor serum triglyceride levels prior to and periodically during therapy.
    • Monitor serum ALT periodically during therapy. May cause ↑ serum ALT without concurrent ↑ in AST levels.
    • Monitor serum LDL cholesterol levels periodically during therapy. May cause ↑ in serum LDL levels.

Potential Nursing Diagnoses

Noncompliance (Patient/Family Teaching)

Implementation

  • Do not confuse Lovaza with lorazepam.
  • An appropriate lipid-lowering diet should be followed before therapy and should continue during therapy.
  • Oral: May be taken as a single 4-g dose or as 2 g twice daily. May be administered with meals. Swallow capsules whole; do not break or chew.

Patient/Family Teaching

  • Instruct patient to take medication as directed, not to skip doses or double up on missed doses. Take missed doses as soon as remembered, but if a day is missed, do not double doses the next day. Medication helps control but does not cure elevated serum triglyceride levels.
  • Advise patient that this medication should be used in conjunction with diet restrictions (fat, cholesterol, carbohydrates, alcohol), exercise, weight loss in overweight patients, and control of medical problems (such as diabetes mellitus and hypothyroidism) that may contribute to hypertriglyceridemia.
  • Emphasize the importance of follow-up exams to determine effectiveness.

Evaluation/Desired Outcomes

  • Lowering of serum triglyceride levels. Patients who do not have an adequate response after 2 mo of treatment should be withdrawn from therapy.
References in periodicals archive ?
Omega-3-acid Ethyl esters (Lovaza) for severe hypertriglyceridemia.
Pronova BioPharma ASA ( Pronova ) and Takeda Pharmaceutical Company Limited ( Takeda ) today announced that the Japanese Ministry of Health, Labour and Welfare has approved a New Drug Application (NDA) of Lotriga granular capsule 2g (generic name: omega-3-acid ethyl esters 90) for the treatment of hyperlipidemia.
Each 1-gram get capsule contains 90% omega-3-acid ethyl esters.
This Pipeline Developer report covers Omega-3-acid ethyl esters
Legal Services Industry: Omega-3-acid ethyl esters - Comprehensive patent search
Generic Drug Industry: Omega-3-acid ethyl esters - Comprehensive patent search
Study of the Pharmacokinetic Interaction Between Simvastatin and Prescription Omega-3-Acid Ethyl Esters.
1,2,5) The unique, patented manufacturing process for Omacor results in a highly purified, highly concentrated capsule that contains 90 percent omega-3-acid ethyl esters.
Each one-gram Omacor gel capsule contains 90 percent omega-3-acid ethyl esters and is available only by prescription.