Medically reviewed by Drugs.com. Last updated on Jan 23, 2019.
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- Docosahexaenoic Acid
- Eicosapentaenoic Acid
- Ethyl Eicosapentaenoate
- Ethyl Esters of Omega-3 Fatty Acids
- Ethyl Icosapentate
- Ethyl-Eicosapentaenoic Acid
- Fish Oil
- Icosapent Ethyl
- Omega 3
- Omega-3-Acid Ethyl Esters
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Dialyvite Omega-3 Concentrate: 600 mg
Expecta LIPIL: 200 mg [DSC]
Lovaza: 1 g [contains soybean oil, tocopherol, dl-alpha]
Ocean Blue MiniCaps Omega-3: 350 mg [gluten free, lactose free, sugar free; contains fd&c red #40, fd&c yellow #10 (quinoline yellow)]
Omega Power: 1050 mg [gluten free, lactose free, sugar free; contains fd&c red #40, fd&c yellow #10 (quinoline yellow); vanilla flavor]
Omega-3 2100: 1050 mg [odorless; orange flavor]
Triklo: 1 g [DSC]
Vascepa: 0.5 g, 1 g
Generic: 300 mg, 500 mg, 1000 mg, 1 g
Capsule, Oral [preservative free]:
Fish Oil Concentrate: 1000 mg [gluten free, lactose free, milk free, no artificial color(s), no artificial flavor(s), no artificial sweetener, sodium free, starch free, sugar free, wheat free, yeast free]
Maximum Red Krill: 300 mg [gluten free; contains soybean oil]
Omega-3 Fish Oil Ex St: 880 mg [gluten free]
Salmon Oil-1000: 200 mg [corn free, rye free, starch free, sugar free, wheat free]
Sam-E.P.A.: 200-300 MG [dye free]
Sea-Omega: 1000 mg [cholesterol free, corn free, gluten free, milk derivatives/products, no artificial color(s), no artificial flavor(s), sodium free, starch free, sugar free, yeast free; contains soybeans (glycine max)]
Generic: 200 mg, 1000 mg, 1200 mg
Capsule Delayed Release, Oral:
Odorless Coated Fish Oil: 1000 mg [gluten free, lactose free, milk free, no artificial color(s), no artificial flavor(s), no artificial sweetener, starch free, sugar free, wheat free, yeast free]
Pro Nutrients Omega 3: 332.5 mg
Generic: 1000 mg
Tablet Chewable, Oral:
Omega-3 IQ: 240 mg [fruit flavor]
Brand Names: U.S.
- Dialyvite Omega-3 Concentrate [OTC]
- Expecta LIPIL [OTC] [DSC]
- Fish Oil Concentrate [OTC]
- Maximum Red Krill [OTC]
- Ocean Blue MiniCaps Omega-3 [OTC]
- Odorless Coated Fish Oil [OTC]
- Omega Power [OTC]
- Omega-3 2100 [OTC]
- Omega-3 Fish Oil Ex St [OTC]
- Omega-3 IQ [OTC]
- Pro Nutrients Omega 3 [OTC]
- Salmon Oil-1000 [OTC]
- Sam-E.P.A. [OTC]
- Sea-Omega [OTC]
- Triklo [DSC]
- Antilipemic Agent, Omega-3 Fatty Acids
Reduction in the hepatic production of triglyceride-rich very low-density lipoproteins (VLDL). Possible cellular mechanisms include inhibition of acyl CoA:1,2 diacylglycerol acyltransferase, increased hepatic mitochondrial and peroxisomal beta-oxidation, and a reduction in the hepatic synthesis of triglycerides.
Omega-3-carboxylic acids: Directly absorbed in the small intestine. Administration with a high-fat meal results in an increased overall exposure of total and free baseline-adjusted EPA by ~140% and 80%, respectively, compared to fasting conditions; a 40% increase in AUC occurred for baseline-adjusted free DHA.
Icosapent ethyl: De-esterified to active metabolite (EPA) which is absorbed in the small intestine
Vdss: EPA: ~88 L
EPA and DHA are mainly oxidized in the liver similar to fatty acids derived from dietary sources. EPA: minor via CYP-450
Time to Peak
Omega-3-carboxylic acids: Following repeat dosing with low-fat meals for ~2 weeks (steady state): EPA: 5 to 8 hours; DHA: 5 to 9 hours
Icosapent ethyl: EPA: ~5 hours
EPA: ~37 to 89 hours; DHA: ~46 hours
Special Populations: Gender
Females tended to have more uptake of EPA into serum phospholipids than males. The clinical significance of this is unknown.
Use: Labeled Indications
Dietary supplement: As dietary supplements for patients at early risk of coronary artery disease
Note: Recommendations from the American Heart Association (AHA) state that patients without documented coronary heart disease (CHD) should eat a variety of fish, preferably oily fish (eg, salmon), at least twice a week, or daily in patients with documented CHD (AHA [Kris-Etherton 2002]).
Hypertriglyceridemia (Lovaza, Epanova, and Vascepa): As an adjunct to diet to reduce triglyceride levels in adults with severe (≥500 mg/dL) hypertriglyceridemia.
Note: The Endocrine Society recommends that omega-3 fatty acids may be considered for triglyceride levels >1,000 mg/dL and may be used alone or in combination with HMG-CoA reductase inhibitors (Berglund 2012). A number of OTC formulations containing omega-3 fatty acids are marketed as nutritional supplements; these do not have FDA-approved indications and may not contain the same amounts of the active ingredient.
Off Label Uses
Cardiovascular risk reduction with mild hypertriglyceridemia
Data from a randomized, double blind trial in patients with a history of cardiovascular disease (CVD) or with diabetes and additional risk factors for CVD support the use of icosapent ethyl for reducing cardiovascular events in patients already receiving a stable dose of a statin who achieve LDL-cholesterol <100 mg/dL, but continue to have fasting triglycerides of 150 to 499 mg/dL [Bhatt 2019].
According to the American Heart Association (AHA) scientific statement on omega-3 polyunsaturated fatty acid (fish oil) supplementation and the prevention of clinical cardiovascular disease, the use of omega-3 fatty acids is reasonable only for the secondary prevention of CHD and to prevent hospitalizations and mortality in patients with heart failure and reduced ejection fraction [AHA [Siscovick 2017]].
Data from a randomized, open-label, parallel-group clinical trial support the use of omega-3 fatty acids [Lovaza] in the treatment (ie, slowing rate of renal function loss) of IgA nephropathy [Donadio 2001]. A more recent meta-analysis does not confirm the efficacy for this indication, though it may likely be used for this indication [Liu 2012]. Additional trials may be necessary to further define the role of omega-3 fatty acids in the treatment of patients with IgA nephropathy.
Based on the Caring for Australasians with Renal Impairment (CARI) guidelines early and prolonged treatment with fish oil may retard the rate of decline in renal function in adults with progressive IgA nephropathy; optimal dosing has yet to be established [CARI [Harris 2006]]. Routine use is currently not recommended (Laville 2004).
Hypersensitivity (eg, anaphylactic reaction) to omega-3 fatty acids or any component of formulation.
Cardiovascular risk reduction with mild hypertriglyceridemia (off-label use): Note: Consider in patients who are already receiving a stable statin dose and have LDL-cholesterol <100 mg/dL, but continue to have fasting triglycerides of 150 to 499 mg/dL (Bhatt 2019).
Oral: Vascepa: 2 g twice daily with meals (Bhatt 2019).
Epanova: 2 g (2 capsules) or 4 g (4 capsules) once daily.
Lovaza: 4 g (4 capsules) once daily or 2 g (2 capsules) twice daily.
Vascepa: 2 g (2 [1 gram] capsules or 4 [0.5 g] capsules) twice daily with meals.
IgA nephropathy (off-label use): Oral: Lovaza: 4 g (4 capsules) once daily (Donadio 2001).
Refer to adult dosing.
Epanova, Lovaza: Administer with or without food. Administer whole; do not break, crush, dissolve, or chew.
Vascepa: Administer with meals. Administer whole; do not break, crush, dissolve, or chew.
Dietary modification is important in the control of severe hypertriglyceridemia. Maintain standard cholesterol-lowering diet during therapy.
Epanova, Lovaza: Store at 25°C (77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F); do not freeze.
Vascepa: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F).
Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): Omega-3 Fatty Acids may enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy
Anticoagulants: Omega-3 Fatty Acids may enhance the anticoagulant effect of Anticoagulants. Monitor therapy
Ibrutinib: Omega-3 Fatty Acids may enhance the antiplatelet effect of Ibrutinib. Monitor therapy
>10%: Gastrointestinal: Diarrhea (7% to 15%)
1% to 10%:
Gastrointestinal: Nausea (4% to 6%), abdominal pain (3% to 5%), dysgeusia (4%), eructation (3% to 4%), dyspepsia (3%)
Neuromuscular & skeletal: Arthralgia (2%)
Frequency not defined:
Central nervous system: Fatigue
Dermatologic: Pruritus, skin rash
Endocrine & metabolic: Increased LDL cholesterol
Gastrointestinal: Abdominal distension, constipation, flatulence, gastrointestinal disease, vomiting
Hematologic & oncologic: Prolonged bleeding time
Hepatic: Increased serum ALT, increased serum AST
Respiratory: Nasopharyngitis, oropharyngeal pain
<1%, postmarketing, and/or case reports: Anaphylaxis, cardiac arrhythmia, hemorrhagic diathesis
Concerns related to adverse effects:
• Fish allergy: Use with caution in patients with known allergy or sensitivity to fish and/or shellfish.
• Hepatic effects: ALT may increase without concurrent AST increase; periodically monitor hepatic transaminases in patients with hepatic impairment.
• Lipid effects: May increase LDL levels; periodically monitor LDL levels.
• Prolongation of bleeding time: Prolongation of bleeding time not exceeding normal limits has been observed in some clinical studies with omega-3 fatty acids; use with caution in patients with coagulopathy or in those receiving therapeutic anticoagulation or antiplatelet therapy. Monitor for changes in INR following initiation and dosage changes of omega-3 fatty acids in patients receiving warfarin.
• Atrial fibrillation (AF): Omega-3 fatty acids are not indicated for the treatment of AF or flutter. Recurrent AF or flutter may occur in patients with symptomatic paroxysmal or persistent AF treated with omega-3 fatty acids; more frequent occurrences were observed with omega-3 fatty acids in the first 2 to 3 months of therapy compared to placebo in clinical trials. However, the clinical significance of these results is uncertain.
• Conditions associated with abnormal lipids: Manage concurrent conditions (eg, diabetes, hypothyroidism, excessive alcohol intake) that may contribute to lipid abnormalities.
• Appropriate use: Should be used as an adjunct to diet therapy and exercise. Secondary causes of hyperlipidemia should be ruled out prior to therapy. The effect, if any, of omega-3 fatty acids on the risk of pancreatitis or cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia is not known.
Triglycerides and other lipids (LDL-C) should be monitored at baseline and periodically. In patients with hepatic impairment, monitor hepatic transaminase levels, particularly ALT, periodically.
2013 ACC/AHA Blood Cholesterol Guideline recommendations (Stone, 2013): Consider evaluation for GI disturbances, skin changes, and bleeding during therapy.
Pregnancy Risk Factor
Adverse events have been observed in animal reproduction studies. Adequate intake of omega-3 fatty acids is recommended during pregnancy (IOM 2005; Nordgren 2017). Maternal use of supplements or dietary consumption of omega-3 fatty acids (containing eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]) influences fetal concentrations (Büyükuslu 2017; Coletta 2010; Miles 2011).
Triglyceride concentrations increase during pregnancy as required for normal fetal development. When increases are greater than expected, supervised dietary interventions that include omega-3 fatty acids may be initiated. In women who develop very severe hypertriglyceridemia and are at risk for pancreatitis, use of prescription omega-3 fatty acid products may be considered (Avis 2009; Berglund 2012; Jacobson 2015; Wong 2015).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience burping, change in taste, nausea, abdominal pain, joint pain, or diarrhea. Have patient report immediately to prescriber abnormal heartbeat, bruising, or bleeding (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
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