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warnings and cautions
5 WARNINGS AND PRECAUTIONS • In some patients, EPANOVA increases LDL-C levels. LDL-C levels should be monitored periodically during therapy with EPANOVA. ( 5.1 ) • In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy. ( 5.1 ) • EPANOVA should be used with caution in patients with known hypersensitivity to fish and/or shellfish. ( 5.2 ) 5.1 Monitoring: Laboratory Tests In some patients, EPANOVA increases LDL-C levels. LDL-C levels should be monitored periodically during therapy with EPANOVA. In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be monitored periodically during therapy with EPANOVA. 5.2 Fish Allergy EPANOVA contains polyunsaturated free fatty acids derived from fish oils. It is not known whether patients with allergies to fish and/or shellfish, are at increased risk of an allergic reaction to EPANOVA. EPANOVA should be used with caution in patients with known hypersensitivity to fish and/or shellfish.
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥3% and greater than placebo) are diarrhea, nausea, abdominal pain or discomfort, and eructation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions reported by at least 3% of EPANOVA-treated individuals and with a higher incidence than placebo (olive oil), based on pooled data from two clinical trials of 6- and 12-week duration involving subjects with hypertriglyceridemia, are listed in Table 1 . Table 1. Adverse Reactions Occurring at Incidence ≥3% and Greater than Placebo in Placebo-Controlled Trials* * Trials included subjects with hypertriglyceridemia of varying severity. Adverse Reaction Placebo N=314 EPANOVA 2 g N=315 EPANOVA 4 g N=315 Diarrhea 2% 7% 15% Nausea 1% 4% 6% Abdominal pain or discomfort 2% 3% 5% Eructation <1% 3% 3% Additional adverse reactions included vomiting, flatulence and dysgeusia. In a pool of two longer-term (≥52 weeks) placebo-controlled clinical trials involving 748 patients (376 EPANOVA 4 grams per day; 372 placebo) with chronic gastrointestinal disease, additional common adverse reactions reported more often by EPANOVA-treated patients included abdominal distension, constipation, vomiting, fatigue, nasopharyngitis, arthralgia, and dysgeusia.