"The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemi"...
VASCEPA® (icosapent ethyl) 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 and exercise regimen before receiving VASCEPA and should continue this diet and exercise regimen with VASCEPA.
Attempts should be made to control any medical problems such as diabetes mellitus, hypothyroidism, and alcohol intake that may contribute to lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed, if possible, prior to consideration of TG-lowering drug therapy.
Limitations of Use
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
The effect of VASCEPA on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
DOSAGE AND ADMINISTRATION
Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate. [see INDICATIONS AND USAGE].
Patients should engage in appropriate nutritional intake and physical activity before receiving VASCEPA, which should continue during treatment with VASCEPA.
The daily dose of VASCEPA is 4 grams per day taken as 2 capsules twice daily with food.
Patients should be advised to swallow VASCEPA capsules whole. Do not break open, crush, dissolve, or chew VASCEPA.
Dosage Forms And Strengths
VASCEPA capsules are supplied as 1-gram amber-colored soft-gelatin capsules imprinted with VASCEPA.
Storage And Handling
VASCEPA (icosapent ethyl) capsules are supplied as 1-gram amber-colored soft-gelatin capsules imprinted with VASCEPA.
Bottles of 120: NDC 52937-001-20.
Store at 20° to 25° C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
Distributed by: Amarin Pharma Inc. Bedminster, NJ, USA. Manufactured by: Banner Pharmacaps Tilburg, The Netherlands or Catalent Pharma Solutions, LLC St. Petersburg, FL, USA. Manufactured for: Amarin Pharmaceuticals Ireland Limited Dublin, Ireland +1-855-VASCEPA (+1-855-827-2372). Revised: Nov 2011
Last reviewed on RxList: 12/6/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Vascepa Information
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