VASCEPA- icosapent ethyl capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

icosapent ethyl (UNII: 6GC8A4PAYH) (icosapent - UNII:AAN7QOV9EA)

Available from:

Amarin Pharma Inc.

INN (International Name):

icosapent ethyl

Composition:

icosapent ethyl 1000 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VASCEPA® (icosapent ethyl) is indicated: - as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease. - established cardiovascular disease or - diabetes mellitus and 2 or more additional risk factors for cardiovascular disease. - as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Limitations of Use: The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components. Risk Summary The available data from published case reports and the pharmacovigilanc

Product summary:

VASCEPA (icosapent ethyl) capsules are supplied as 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].

Authorization status:

New Drug Application

Summary of Product characteristics

VASCEPA- ICOSAPENT ETHYL CAPSULE
AMARIN PHARMA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VASCEPA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VASCEPA.
VASCEPA (ICOSAPENT ETHYL) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2012
INDICATIONS AND USAGE
VASCEPA is an ethyl ester of eicosapentaenoic acid (EPA) indicated:
as an adjunct to maximally tolerated statin therapy to reduce the risk
of myocardial infarction, stroke,
coronary revascularization, and unstable angina requiring
hospitalization in adult patients with elevated
triglyceride (TG) levels(≥ 150 mg/dL) and
established cardiovascular disease or
diabetes mellitus and 2 or more additional risk factors for
cardiovascular disease. (1)
as an adjunct to diet to reduce TG levels in adult patients with
severe (≥ 500 mg/dL)
hypertriglyceridemia. (1)
Limitations of Use:
The effect of VASCEPA on the risk for pancreatitis in patients with
severe hypertriglyceridemia has not
been determined. (1)
DOSAGE AND ADMINISTRATION
Assess lipid levels before initiating therapy. Identify other causes
of high triglyceride levels and manage
as appropriate. (2.1)
Patients should engage in appropriate nutritional intake and physical
activity before receiving VASCEPA,
which should continue during treatment. (2.1)
The daily dose of VASCEPA is 4 grams per day taken as either
four 0.5 gram capsules twice daily with food or
two 1 gram capsules twice daily with food. (2.2)
Advise patients to swallow capsules whole. Do not break open, crush,
dissolve, or chew VASCEPA. (2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 0.5 gram and 1 gram (3)
CONTRAINDICATIONS
VASCEPA is contraindicated in patients with known hypersensitivity
(e.g., anaphylactic reaction) to
VASCEPA or any of its components. (4)
WARNINGS AND PRECAUTIONS
_Atrial Fibrillation/Flutter:_ VASCEPA was associated with an
increased risk of atrial fibrillation or atrial flutter
requiring hospitalization in a double-blind, placebo-controlled trial