IMPORTANT SAFETY INFORMATION FOR EPANOVA® (omega-3-carboxylic acids) Capsules
EPANOVA is contraindicated in patients with known hypersensitivity to EPANOVA or any of its components
In some patients, EPANOVA increases LDL-C levels. LDL-C levels should be monitored periodically during therapy with EPANOVA
In patients with hepatic impairment, ALT and AST levels should be monitored periodically during therapy with EPANOVA
EPANOVA should be used with caution in patients with known hypersensitivity to fish and/or shellfish
Some published studies with omega-3-fatty acids demonstrated prolongation of bleeding time, which did not exceed normal limits and did not produce clinically significant bleeding episodes. Patients taking anti-platelet agents or anticoagulants were excluded from EPANOVA clinical trials involving patients with hypertriglyceridemia. Nonetheless, patients receiving treatment with EPANOVA and an anticoagulant or other drugs affecting coagulation (eg, anti-platelet agents) should be monitored periodically
Most common adverse reactions with EPANOVA 2 grams and 4 grams, respectively, were diarrhea (7%, 15%),nausea (4%, 6%), abdominal pain or discomfort (3%, 5%) and eructation (3%, 3%)
EPANOVA is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving EPANOVA and should continue this diet during treatment with EPANOVA.
Laboratory studies should be done to ascertain that the triglyceride levels are consistently abnormal before instituting EPANOVA therapy. Attempts should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.
Limitations of Use:
The effect of EPANOVA on the risk for pancreatitis has not been determined.
The effect of EPANOVA on cardiovascular mortality and morbidity has not been determined.