EPANOVA® (omega-3-carboxylic acids) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe ( ≥ 500 mg/dL) hypertriglyceridemia.
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.
DOSAGE AND ADMINISTRATION
The dosage of EPANOVA is 2 grams (2 capsules) or 4 grams (4 capsules) once daily. The dosage should be individualized according to the patient's response and tolerability. In clinical trials, EPANOVA was administered without regard to meals.
Patients should be advised to swallow EPANOVA capsules whole. Do not break open, crush, dissolve or chew EPANOVA.
Dosage Forms And Strengths
EPANOVA (omega-3-carboxylic acids) capsules are supplied as 1-gram, red/brown coated, soft-gelatin capsules imprinted with OME1.
Storage And Handling
EPANOVA is supplied as a 1-gram, red/brown, polyacrylate-coated, soft-gelatin capsule bearing the designation OME1. Available in bottles of 60 capsules (NDC 0310-2222-60). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Keep out of reach of children.
Manufactured by: Catalent Germany GmbH Eberbach and Schorndorf, Germany. Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850
Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE. Issued 05/2014
Last reviewed on RxList: 5/20/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Epanova Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Tips to keep it under control.