icosapent (Rx)

Brand and Other Names:Vascepa
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 0.5g
  • 1g

Severe Hypertriglyceridemia

Indications

  • Indicated as an adjunct to diet to reduce high triglyceride (TG) levels (ie, ≥500 mg/dL)
  • Cardiovascular risk reduction
    • Indicated as an adjunct to maximally tolerated statin therapy to reduce risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adults with elevated TG levels (≥150 mg/dL), AND
    • Established cardiovascular disease, OR
    • Diabetes mellitus and 2 or more additional risk factors for CV disease

Dose

  • 2g PO q12hr with food

Dosing Considerations

Limitation of use

  • Effect on risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined

Before initiating

  • Assess lipid levels; identify other causes (eg, diabetes mellitus, hypothyroidism, medications) of high triglyceride levels and manage as appropriate
  • Patients should engage in appropriate nutritional intake and physical activity before and during icosapent treatment
  • Measure ALT/AST periodically in patients with hepatic impairment

Safety and efficacy not established

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Interactions

Interaction Checker

and icosapent

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Bleeding event (12%)

            1-10%

            Musculoskeletal pain (≥3%)

            Peripheral edema (≥3%)

            Constipation (≥3%)

            Gout (≥3%)

            Atrial fibrillation or flutter (3%)

            Serious bleeding event (3%)

            Postmarketing Reports

            Diarrhea

            Blood TG increased

            Abdominal discomfort

            Pain in extremities

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            Warnings

            Contraindications

            Hypersensitivity to drug or any of its components

            Cautions

            Associated with increased risk of atrial fibrillation or atrial flutter requiring hospitalization compared with placebo (3% vs 2%)

            Contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fish; unknown whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction

            Use associated with increased risk of bleeding; incidence is greater if taking concomitant antithrombotic medications (eg, aspirin, clopidogrel, or warfarin)

            Drug interaction overview

            • Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time; bleeding time reported in those studies has not exceeded normal limits and did not produce clinically significant bleeding episodes
            • Monitor patients receiving icosapent with anticoagulants and/or antiplatelet agents for bleeding
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            Pregnancy & Lactation

            Pregnancy

            Available data from published case reports and the pharmacovigilance database on the use in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes

            Animal studies

            • In animal reproduction studies in pregnant rats, nondose-related imbalances for some minor developmental findings were observed with oral administration of icosapent ethyl during organogenesis at exposures that were equivalent to the clinical exposure at the human dose of 4 g/day, based on body surface area comparisons

            Lactation

            Published studies have detected omega-3 fatty acids, including EPA, in human milk

            Lactating women receiving oral omega-3 fatty acids for supplementation have resulted in higher levels of omega-3 fatty acids in human milk

            There are no data on the effects of omega-3 fatty acid ethyl esters on the breastfed infant or on milk production

            Consider developmental and health benefits of breastfeeding along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Ethyl ester of eicosapentaenoic acid (EPA); EPA has been shown to reduce hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion; enhances triglyceride clearance from circulating VLDL particle; may also increase beta-oxidation, inhibits acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT), decrease lipogenesis in liver, and increase plasma lipoprotein lipase activity

            The mechanisms of action contributing to reduction of cardiovascular events are not completely understood but are likely multifactorial; increased EPA lipid composition from carotid plaque specimens and increased circulating EPA/arachidonic acid ratio have been observed following EPA treatment; EPA inhibits platelet aggregation under some ex vivo conditions

            Absorption

            De-esterified during absorption to active EPA that is absorbed in small intestine

            Peak Plasma Time: 5 hr

            Distribution

            Protein Bound: >99% of unesterified EPA

            Vd: 88 L

            Metabolism

            Mainly metabolized by the liver via beta-oxidation similar to dietary fatty acids; minor CYP450 mediated metabolism

            Elimination

            Half-life: 89 hr

            Does not undergo renal excretion

            Total plasma clearance: 684 mL/hr

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            Administration

            Oral Administration

            Swallow capsule whole; do not break open, dissolve, crush, or chew

            Storage

            Store at controlled room temperature of 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.