IPE: The VASCEPA difference

VASCEPA is icosapent ethyl (IPE), the only FDA-approved EPA and CV risk–reducing agent.1

The unique molecular structure of prodrug IPE allows for an effective delivery of the active ingredient, which is best absorbed through the small intestine. Additionally, IPE has undergone a proprietary purification process which has been approved and validated by the FDA. This process effectively removes LDL-raising DHA, saturated fats, toxins, and other impurities, leaving only a single purified ingredient.* And, in 2019, the FDA designated this single purified ingredient, IPE, a new chemical entity.2

This single, purified ingredient is FDA-approved VASCEPA, also known as IPE*

What type of patient can benefit from VASCEPA?

Find out

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IMPORTANT SAFETY INFORMATION

VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components

VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter

It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur

INDICATIONS AND LIMITATIONS OF USE

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

VASCEPA is indicated as an adjunct to diet to reduce TG levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia

The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin

Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%) and atrial fibrillation (5% vs 4%)

Common adverse reactions in the hypertriglyceridemia trials (incidence ≥1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%)

Adverse Events, Product Complaints, or Special Situations may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088

Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding

Please see full Prescribing Information for more information on VASCEPA.

*Data on file.

References: 1. Borow KM, Nelson JR, Mason RP. Biologic plausibility, cellular effects, and molecular mechanisms of eicosapentaenoic acid (EPA) in atherosclerosis. Atherosclerosis. 2015;242(1):357-366. 2. U.S. FDA grants priority review for VASCEPA® (icosapent ethyl) supplemental new drug application seeking cardiovascular risk reduction indication [press release]. Dublin, Ireland, and Bridgewater, NJ: Amarin Corporation; May 29, 2019. 3. US Food and Drug Administration. Letter responding to health claim petition dated June 23, 2003 (wellness petition): omega-3 fatty acids and reduced risk of coronary heart disease (docket no. 2003Q-0401). http://wayback.archive-it.org/7993/20171114183726/https://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm072936.htm. Published September 8, 2004. Accessed March 24, 2020. 4. Department of Health and Human Services. 21 CFR Part 184 [docket no. 86G-0289]: Substances affirmed as generally recognized as safe: menhaden oil. Federal Register. 1997;62(108):30751-30757. 5. VASCEPA [package insert]. Bridgewater, NJ: Amarin Pharma, Inc.; 2019.