Version May 2024
Note: All patients should receive general measures (ie, address modifiable causes, manage atherosclerotic cardiovascular disease [ASCVD] risk, implement lifestyle modification [eg, dietary changes, reduction of alcohol consumption]) and optimal low-density lipoprotein (LDL) lowering therapy for 4 to 12 weeks before considering triglyceride lowering therapy (Ref).
Cardiovascular risk reduction with hypertriglyceridemia (adjunctive agent):
Note: For patients whose triglycerides remain ≥150 mg/dL after general measures and optimal LDL lowering therapy who warrant additional ASCVD risk reduction (ie, those with established ASCVD or diabetes mellitus plus ≥2 risk factors for ASCVD), use icosapent ethyl over other triglyceride lowering therapies (Ref).
Oral: 2 g twice daily with meals (Ref).
Hypertriglyceridemia (adjunctive agent):
Note: For patients whose triglycerides remain ≥500 mg/dL after general measures and optimal LDL lowering therapy who do not warrant additional ASCVD risk reduction, any prescription strength omega-3 fatty acid (including icosapent ethyl) or a fibrate (fenofibrate preferred) is reasonable (Ref).
Oral: 2 g twice daily with meals.
There are no dosage adjustments provided in manufacturer's labeling (has not been studied). Eicosapentaenoic acid is not renally eliminated.
There are no dosage adjustments provided in 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.
>10%: Hematologic & oncologic: Hemorrhage (12%; major hemorrhage: 3%)
1% to 10%:
Cardiovascular: Atrial fibrillation, atrial flutter, peripheral edema
Endocrine & metabolic: Gout
Gastrointestinal: Constipation
Neuromuscular & skeletal: Musculoskeletal pain
Frequency not defined:
Neuromuscular & skeletal: Arthralgia
Respiratory: Oropharyngeal pain
Postmarketing:
Endocrine & metabolic: Increased serum triglycerides
Gastrointestinal: Abdominal distress, diarrhea
Neuromuscular & skeletal: Limb pain
Hypersensitivity (eg, anaphylactic reaction) to icosapent ethyl or any component of the 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.
Disease related concerns:
• Atrial fibrillation: Atrial fibrillation (AF) or flutter requiring hospitalization may occur; risk increased in patients with a history of AF or flutter.
• Conditions associated with abnormal lipids: Manage concurrent conditions (eg, diabetes, hypothyroidism, excessive alcohol intake) that may contribute to lipid abnormalities.
• Hepatic impairment: Studies have not been conducted in patients with hepatic impairment; however, ALT/AST levels should be monitored periodically during therapy in hepatically-impaired patients.
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. 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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Vascepa: 0.5 g, 1 g
Generic: 0.5 g, 1 g
Yes
Capsules (Icosapent Ethyl Oral)
0.5 g (per each): $1.97
1 g (per each): $3.14 - $3.37
Capsules (Vascepa Oral)
0.5 g (per each): $2.07
1 g (per each): $3.55
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Vascepa: 1 g
Oral: Administer with food. Swallow whole; do not break, crush, dissolve, or chew.
Cardiovascular risk reduction with hypertriglyceridemia: As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with triglyceride levels ≥150 mg/dL and either established cardiovascular disease or type 2 diabetes mellitus with ≥2 risk factors for cardiovascular disease.
Hypertriglyceridemia: As an adjunct to diet to reduce triglyceride levels in adults with severe (≥500 mg/dL) hypertriglyceridemia.
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.): Icosapent Ethyl may enhance the antiplatelet effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy
Anticoagulants: Icosapent Ethyl may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy
Ibrutinib: Icosapent Ethyl 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 may influence milk concentrations (IOM 2005).
According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Take with food. 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 ALT and AST periodically during treatment. Signs/symptoms of bleeding.
2013 American College of Cardiology/American Heart Association blood cholesterol guideline recommendations (Stone 2014): 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 multifactorial (eg, increased eicosapentaenoic acid [EPA] composition from carotid plaques, increased circulating EPA/arachidonic acid ratio, inhibition of platelet aggregation).
Absorption: De-esterified to active metabolite (eicosapentaenoic acid [EPA]), which is absorbed in the small intestine.
Distribution: Vdss: ~88 L.
Protein binding: >99%.
Metabolism: EPA is mainly oxidized in the liver similar to fatty acids derived from dietary sources. EPA: minor via CYP-450.
Half-life elimination: EPA: ~37 to 89 hours.
Time to peak, plasma: ~5 hours.
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