omega 3 carboxylic acids (Rx)

Brand and Other Names:Epanova
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 1g
  • Note: 1g capsule free fatty acids derived from fish oil contains at least 850mg of polyunsaturated fatty acids, including omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) being the most abundant

Hypertriglyceridemia

Indicated as an adjunct to diet in patients with severe hypertriglyceridemia (ie, TG ≥500 mg/dL)

2-4 g PO qDay

Individualize dose according to response and tolerability

Dosing Considerations

Effect on risk of pancreatitis has not been determined

Effect on cardiovascular mortality and morbidity has not been determined

Safety and efficacy not established

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Interactions

Interaction Checker

and omega 3 carboxylic acids

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                Monitor Closely (26)

                • alteplase

                  omega 3 carboxylic acids, alteplase. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • anagrelide

                  omega 3 carboxylic acids, anagrelide. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • antithrombin alfa

                  omega 3 carboxylic acids, antithrombin alfa. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • antithrombin III

                  omega 3 carboxylic acids, antithrombin III. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • argatroban

                  omega 3 carboxylic acids, argatroban. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • aspirin

                  omega 3 carboxylic acids, aspirin. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • aspirin/citric acid/sodium bicarbonate

                  omega 3 carboxylic acids, aspirin/citric acid/sodium bicarbonate. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • betrixaban

                  omega 3 carboxylic acids, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.

                • bivalirudin

                  omega 3 carboxylic acids, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • cilostazol

                  omega 3 carboxylic acids, cilostazol. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • clopidogrel

                  omega 3 carboxylic acids, clopidogrel. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • dabigatran

                  omega 3 carboxylic acids, dabigatran. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • dalteparin

                  omega 3 carboxylic acids, dalteparin. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • desirudin

                  omega 3 carboxylic acids, desirudin. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • dipyridamole

                  omega 3 carboxylic acids, dipyridamole. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • enoxaparin

                  omega 3 carboxylic acids, enoxaparin. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • fondaparinux

                  omega 3 carboxylic acids, fondaparinux. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • heparin

                  omega 3 carboxylic acids, heparin. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • prasugrel

                  omega 3 carboxylic acids, prasugrel. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • reteplase

                  omega 3 carboxylic acids, reteplase. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • tenecteplase

                  omega 3 carboxylic acids, tenecteplase. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • ticlopidine

                  omega 3 carboxylic acids, ticlopidine. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • vorapaxar

                  omega 3 carboxylic acids, vorapaxar. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Coadministration of anticoagulants, antiplatelets, or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • vortioxetine

                  omega 3 carboxylic acids, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • warfarin

                  omega 3 carboxylic acids, warfarin. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

                • zanubrutinib

                  omega 3 carboxylic acids, zanubrutinib. Either increases effects of the other by anticoagulation. Modify Therapy/Monitor Closely. Zanubrutinib-induced cytopenias increases risk of hemorrhage. Coadministration of zanubritinib with antiplatelets or anticoagulants may further increase this risk.

                Minor (0)

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                  Adverse Effects

                  >10%

                  Diarrhea (7-15%)

                  1-10%

                  Nausea (4-6%)

                  Abdominal pain/discomfort (3-5%)

                  Eructation (3%)

                  Postmarketing Reports

                  Vomiting

                  Flatulence

                  Dysgeusia

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                  Warnings

                  Contraindications

                  Hypersensitivity (eg, anaphylaxis)

                  Cautions

                  May increase LDL-C levels, monitor periodically

                  Monitor ALT and AST levels periodically in patients with hepatic impairment

                  Contains polyunsaturated free fatty acids derived from fish oils; caution in patients with known allergies to fish and/or shellfish

                  Prolonged bleeding time reported with omega- 3 fatty acids; caution if coadministered with anticoagulants or antiplatelet agents

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                  Pregnancy & Lactation

                  Pregnancy: There are no studies in pregnant women and the limited available data are not sufficient to inform a drug-associated risk for major birth defects or miscarriages

                  Lactation: Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from therapy or from the underlying maternal condition

                  Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

                  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

                  Omega-3 fatty acids reduce hepatic production of triglyceride (TG)-rich very low density lipoproteins (VLDL) and may increase the removal rate of TG-rich lipoproteins by increasing lipoprotein lipase activity, in humans

                  Some potential cellular mechanisms of action include inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increased mitochondrial and peroxisomal beta-oxidation in the liver, and decreased lipogenesis in the liver

                  Absorption

                  Peak plasma time: 5-9 hr

                  Steady state (EPA, DHA) achieved: 2 weeks

                  Directly absorbed in small intestine, then enters systemic circulation mainly via the thoracic duct lymphatic system

                  Distribution

                  Majority of EPA and DHA in plasma incorporated in phospholipids, triglycerides, and cholesteryl esters

                  Metabolism

                  Mainly oxidized in liver to fatty acids derived from dietary sources

                  Elimination

                  Half-life: 37 hr (EPA); 46 hr (DHA)

                  Plasma clearance: 548 mL/hr (EPA); 518 mL/hr (DHA)

                  Does not undergo renal excretion

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                  Administration

                  Oral Administration

                  May take with or without food

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

                  Storage

                  Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

                  Do not freeze

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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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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.

                  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.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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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.