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General: Icosapent ethyl is not the same as, and should not be substituted with, or combined with other products that contain omega-3 fatty acids. Patients should be questioned about which natural health products or dietary supplements they may be taking, and cautioned not to take other omega-3 fatty acid products while they are taking VASCEPA, without first consulting their attending physician.
Bleeding: Treatment with VASCEPA has been associated with an increased incidence of bleeding (see Clinical Trial Adverse Drug Reactions: Adverse Reactions in the REDUCE-IT trial: Hematologic: Bleeding under Adverse Reactions). Patients taking VASCEPA along with antithrombotic agents, i.e., anti-platelet agents, including aspirin, and/or anticoagulants, may be at increased risk of bleeding. Monitor these patients appropriately.
Carcinogenesis and Mutagenesis: No carcinogenicity or mutagenicity data in humans are available (see Pharmacology: Toxicology: Non-clinical Toxicology: Carcinogenicity and Genotoxicity under Actions).
Immune System: It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction to VASCEPA, which is a fish-derived product. VASCEPA should be used with caution in patients with known hypersensitivity to fish and/or shellfish.
Monitoring and Laboratory Tests: In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be monitored periodically during therapy with VASCEPA.
Sexual Health: Fertility: No fertility data in humans are available. No significant effect on fertility was observed in rats receiving eicosapentaenoic acid ethyl ester orally (see Pharmacology: Toxicology: Non-clinical Toxicology: Reproductive and Developmental Toxicology under Actions).
Use in Children: Pediatrics (<18 years): No data are available; therefore, an indication for pediatric use has not been authorized.
Use in the Elderly: Geriatrics (≥65 years): Of the total number of patients in well-controlled clinical studies of VASCEPA, 45% were 65 years of age and over. Effectiveness was consistently observed between these patients and younger patients. No overall differences in safety were observed between age groups.
