Version May 2024
Dietary supplement: 1 to 2 capsules 3 times daily. Note: Composition of OTC products may vary significantly.
Hypertriglyceridemia (adjunctive agent):
Note: All patients should receive general measures (ie, address modifiable causes, manage atherosclerotic cardiovascular disease [ASCVD] risk, implement lifestyle modification [eg, dietary changes, reduction in alcohol consumption]) and optimal low-density lipoprotein lowering therapy for 4 to 12 weeks before considering triglyceride lowering therapy. For patients whose triglycerides remain ≥500 mg/dL and who do not warrant icosapent ethyl for additional ASCVD risk reduction, any prescription strength omega-3 fatty acid (including icosapent ethyl) or a fibrate (fenofibrate preferred) is reasonable (Ref).
Oral: Lovaza: 4 g once daily or 2 g twice daily.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). EPA and DHA are not renally eliminated.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Gastrointestinal: Dysgeusia (4%), dyspepsia (3%), eructation (4%)
Frequency not defined:
Cardiovascular: Atrial fibrillation, atrial flutter
Dermatologic: Pruritus, skin rash
Endocrine & metabolic: Increased LDL cholesterol
Gastrointestinal: Constipation, vomiting
Hepatic: Increased serum alanine aminotransferase, increased serum aspartate aminotransferase
Postmarketing:
Dermatologic: Urticaria
Hematologic & oncologic: Bleeding tendency disorder
Hypersensitivity: Anaphylaxis
Hypersensitivity (eg, anaphylactic reaction) to omega-3 fatty acids or any component of formulation.
Concerns related to adverse effects:
• Bleeding: Bleeding, including serious events, has been reported; risk may be increased with concomitant anticoagulant/antiplatelet use. Prolongation of bleeding time not exceeding normal limits has also been observed; use with caution in patients with coagulopathy. Monitor for signs and symptoms of bleeding.
• 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.
Disease-related concerns:
• Atrial fibrillation: Atrial fibrillation (AF) or flutter may occur; risk increased in patients with a history of AF or flutter and within the first 2 to 3 months of therapy.
• Conditions associated with abnormal lipids: Manage concurrent conditions (eg, diabetes, hypothyroidism, excessive alcohol intake) that may contribute to lipid abnormalities.
Other warnings/precautions:
• 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. 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.
Lovaza: Each 1 g capsule contains the combination of EPA (~465 mg) and DHA (~375 mg) ethyl esters.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, Oral:
Dialyvite Omega-3 Concentrate: 600 mg
Lovaza: 1 g
Lovaza: 1 g [DSC] [contains soybean oil, tocopherol, dl-alpha (vit e)]
Ocean Blue MiniCaps Omega-3: 350 mg [gluten free, lactose free, sugar free; contains fd&c red #40 (allura red ac dye), quinoline yellow (d&c yellow #10)]
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]
Fish Oil High Potency: 1000 mg [dairy free, egg free, gluten free, no artificial color(s), no artificial flavor(s), 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]
Omega-3 Microgel: 600 mg [gluten free, no artificial color(s), no artificial flavor(s)]
Salmon Oil-1000: 200 mg [DSC] [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 soja)]
Generic: 200 mg [DSC], 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 [DSC]
Yes
Capsule, delayed release (Pro Nutrients Omega 3 Oral)
332.5 mg (per each): $0.16
Capsules (Dialyvite Omega-3 Concentrate Oral)
600 mg (per each): $0.18
Capsules (Lovaza Oral)
1 g (per each): $9.52
Capsules (Ocean Blue MiniCaps Omega-3 Oral)
350 mg (per each): $0.20
Capsules (Omega-3-acid Ethyl Esters Oral)
1 g (per each): $0.22 - $4.80
Capsules (Sea-Omega Oral)
1000 mg (per each): $0.14
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral:
Lovaza: Administer with food. Administer whole; do not break, crush, dissolve, or chew.
Bariatric surgery: Capsule, delayed release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. Delayed-release capsule should be administered whole. Do not break, crush, dissolve, or chew. If safety and efficacy of fish oil can be effectively monitored, no change in formulation or administration is required after bariatric surgery; however, re-evaluation of need for omega-3 therapy after bariatric surgery is advised due to known improvements in cholesterol profile.
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): As an adjunct to diet to reduce triglyceride levels in adults with severe (≥500 mg/dL) hypertriglyceridemia.
Lovaza may be confused with LORazepam
Omacor [multiple international markets] may be confused with Amicar brand name for aminocaproic acid [US]
The Institute for Safe Medication Practices (ISMP) reported a case of a foam plastic cup dissolving after contact with the liquid contents from a Lovaza capsule. ISMP is requesting the manufacturer to add warnings to its labeling and that healthcare providers add Lovaza to their list of medications to not crush.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
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. Risk C: Monitor therapy
Anticoagulants: Omega-3 Fatty Acids may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy
Ibrutinib: Omega-3 Fatty Acids may enhance the antiplatelet effect of Ibrutinib. Risk C: Monitor therapy
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 and docosahexaenoic acid) 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).
Omega-3 fatty acids are present in breast milk and dietary supplementation increases milk concentrations (IOM 2005).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Dietary modification is important in the control of severe hypertriglyceridemia. Maintain standard cholesterol-lowering diet during therapy.
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. Signs/symptoms of bleeding.
2013 ACC/AHA Blood Cholesterol Guideline recommendations (Stone 2013): Consider evaluation for GI disturbances and skin changes during therapy.
Reduction in the hepatic production of triglyceride-rich very low-density lipoproteins. 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. The mechanisms contributing to reduction of cardiovascular events are not completely understood but are likely multi-factorial (eg, increased eicosapentaenoic acid [EPA] composition from carotid plaques, increased circulating EPA/arachidonic acid ratio, inhibition of platelet aggregation).
Absorption: 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.
Distribution: Vdss: EPA: ~88 L.
Protein binding: EPA: >99%.
Metabolism: EPA and DHA are mainly oxidized in the liver similar to fatty acids derived from dietary sources. EPA: minor via CYP-450.
Half-life elimination: EPA: ~37 hours; DHA: ~46 hours.
Time to peak, plasma: Following repeat dosing with low-fat meals for ~2 weeks (steady state): EPA: 5 to 8 hours; DHA: 5 to 9 hours.
Sex: Females tended to have more uptake of EPA into serum phospholipids than males. The clinical significance of this is unknown.
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