icosapent (Rx)Brand and Other Names:Vascepa

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 1g
  • Each 1-gram capsule contains at least 96% eicosapentaenoic acid (EPA); does not contain any docosahexaenoic acid (DHA)
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Severe Hypertriglyceridemia

Indicated as an adjunct to diet to reduce high triglyceride levels (ie, ≥500 mg/dL)

2g PO q12hr with food

Administration

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

Safety and efficacy not established

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Interactions

Interaction Checker

icosapent and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Arthralgia (2.3%)

            Frequency Not Defined

            Oropharyngeal pain

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            Warnings

            Contraindications

            Hypersensitivity to drug or any of its components

            Cautions

            Lipid levels should be assessed prior to initiating therapy

            Identify other potential causes of hypertriglyceridemia (eg, hypothyroidism, diabetes mellitus, alcohol intake, medications) and provide appropriate treatment as necessary

            Medications such as estrogens, beta blockers and thiazides have been shown to exacerbate hypertriglyceridemia; discontinue or change medications if possible, otherwise monitor carefully

            Prior to therapy, patients must start on a healthy regimen that includes an appropriate lipid-lowering diet and exercise, and this must be continued during treatment

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

            Effect on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined

            Monitor ALT and AST levels periodically in patients with hepatic impairment

            Contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA) obtained from fish oil; caution in patients with known hypersensitivity to fish and/or shellfish

            Omega-3 fatty acids may cause prolongation of bleeding time; monitor patients receiving concomitant anticoagulants/ anti-platelet therapy periodically

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Omega-3-acid ethyl esters excreted in human breast milk; effects unknown, exercise caution

            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

            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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            Images

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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.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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