PRODUCTS

VASCEPA®/VAZKEPA (icosapent ethyl) Background

VASCEPA (icosapent ethyl) – pronounced vas-EE-puh – is the first prescription cardiovascular treatment approved by the U.S. Food and Drug Administration (FDA) that only contains the active ingredient icosapent ethyl (IPE), a unique form of eicosapentaenoic acid (EPA). The European Commission (EC) has approved the marketing authorization application for VAZKEPA (icosapent ethyl) – pronounced using a short “e” Vaz-kĕ-pah – to reduce the risk of cardiovascular events in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk factor.

On December 13, 2019, VASCEPA became the first drug approved by the FDA for cardiovascular risk reduction 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

No other drug is approved for that important indication.

In addition, VASCEPA is approved by the FDA 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.

IMPORTANT SAFETY INFORMATION

WHO SHOULD NOT TAKE VASCEPA?
  • Do not take VASCEPA if you are allergic to icosapent ethyl or any of the ingredients in VASCEPA.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF VASCEPA?

VASCEPA may cause serious side effects, including:
  • Heart rhythm problems (atrial fibrillation and atrial flutter). Heart rhythm problems which can be serious and cause hospitalization have happened in people who take VASCEPA, especially in people who have heart (cardiovascular) disease or diabetes with a risk factor for heart (cardiovascular) disease, or who have had heart rhythm problems in the past. Tell your doctor if you get any symptoms of heart rhythm problems such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, chest discomfort or you faint.
  • Possible allergic reactions if you are allergic to fish or shellfish. Stop taking VASCEPA and tell your doctor right away or get emergency medical help if you have any signs or symptoms of an allergic reaction.
  • Bleeding. Serious bleeding can happen in people who take VASCEPA. Your risk of bleeding may increase if you are also taking a blood thinner medicine.

If you have liver problems and are taking VASCEPA, your doctor should do blood tests during treatment. The most common side effects of VASCEPA include:

  • Muscle and joint pain
  • Swelling of the hands, legs, or feet
  • Constipation
  • Gout
  • Heart rhythm problems (atrial fibrillation)
These are not all the possible side effects of VASCEPA. Call your doctor for medical advice about side effects. You may report adverse events (i.e. side effects) or product complaints by calling 1-855-VASCEPA (1-855-827-2372), emailing [email protected], or calling the FDA at 1-800-FDA-1088.



Tell your doctor if you take medicines that affect your blood clotting (anticoagulants or blood thinners).



For more information on VASCEPA, click here to see the full Patient Information or call 1-855-VASCEPA (1-855-827-2372)

VASCEPA is not approved for use in all countries and, where approved, labeling is specific to that geography such that the above language from VASCEPA’s FDA-approved label should not be relied upon outside of the United States.

To learn more about VASCEPA, please visit https://vascepa.com/
To learn more about VAZKEPA, please visit https://ec.europa.eu/health/documents/community-register/html/h1524.htm