Dosing and uses of Epanova (omega 3 carboxylic acids)
Adult dosage forms and 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
Administration
May take with or without food
Swallow capsule whole; do not break open, crush, dissolve, or chew
Pediatric dosage forms and strengths
Safety and efficacy not established
Epanova (omega 3 carboxylic acids) adverse (side) effects
>10%
Diarrhea (7-15%)
1-10%
Nausea (4-6%)
Abdominal pain/discomfort (3-5%)
Eructation (3%)
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
Pregnancy and 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.
Pharmacology of Epanova (omega 3 carboxylic acids)
Mechanism of action
Possibly inhibits acyl CoA:1,2-diacylglycerol acyltransferase; may increase mitochondrial and peroxisomal beta-oxidation in liver; may decrease hepatic lipogenesis; plasma lipoprotein lipase activity may increase
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
