Dosing & Uses
Dosage Forms & Strengths
- Each 1-gram capsule contains at least 96% eicosapentaenoic acid (EPA); does not contain any docosahexaenoic acid (DHA)
Indicated as an adjunct to diet to reduce high triglyceride levels (ie, ≥500 mg/dL)
2g PO q12hr with food
Swallow capsule whole; do not break open, dissolve, crush, or chew
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Frequency Not Defined
Hypersensitivity to drug or any of its components
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
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Omega-3-acid ethyl esters excreted in human breast milk; effects unknown, exercise caution
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.
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
De-esterified during absorption to active EPA that is absorbed in small intestine
Peak Plasma Time: 5 hr
Protein Bound: >99% of unesterified EPA
Vd: 88 L
Mainly metabolized by the liver via beta-oxidation similar to dietary fatty acids; minor CYP450 mediated metabolism
Half-life: 89 hr
Does not undergo renal excretion
Total plasma clearance: 684 mL/hr
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|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.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.