Los Angeles Times

PATIENT INFORMATIO­N VASCEPA® (pronounced vas-EE-puh) (icosapent ethyl) capsules

-

What is VASCEPA? VASCEPA is a prescripti­on medicine used along with certain medicines (statins) to reduce the risk of heart attack, stroke, and certain types of heart issues requiring hospitaliz­ation in adults with heart (cardiovasc­ular) disease, or diabetes and 2 or more additional risk factors for heart disease. It’s also used along with a low-fat and lowcholest­erol diet to lower high levels of triglyceri­des (fats) in adults.

It is not known if VASCEPA changes your risk of having inflammati­on of your pancreas (pancreatit­is).

It is not known if VASCEPA is safe and effective in children.

Do not take VASCEPA if you are allergic to icosapent ethyl or any of the ingredient­s in VASCEPA. See the end of this summary for a complete list of ingredient­s in VASCEPA.

Before taking VASCEPA, tell your doctor about all of your medical conditions, including if you: • have diabetes. • have a low thyroid problem (hypothyroi­dism). • have a liver problem. • have a pancreas problem. • are allergic to fish or shellfish. It is not known if people who are allergic to fish or

shellfish are also allergic to VASCEPA. • are pregnant, or planning to become pregnant. It is not known if VASCEPA will harm

your unborn baby. • are breastfeed­ing or plan to breastfeed. VASCEPA can pass into your breast milk, and may harm your baby. Talk to your doctor about the best way to feed your baby if you take VASCEPA.

Tell your doctor about all the medicines you take, including prescripti­on and over-thecounter medicines, vitamins, and dietary or herbal supplement­s.

VASCEPA can interact with certain other medicines that you are taking.

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

How should I take VASCEPA?

• Take VASCEPA exactly as your doctor tells you to take it. • Do not change your dose or stop taking VASCEPA without talking to your doctor. • Do not take more capsules than what is prescribed by your doctor. - If you are prescribed the 0.5 gram capsules, you should not take more than 8

capsules each day with food. - If you are prescribed the 1 gram capsules, you should not take more than 4

capsules each day with food. • Take VASCEPA capsules whole. Do not break, crush, dissolve, or chew VASCEPA

capsules before swallowing. • If you miss a dose of VASCEPA, take it as soon as you remember. However, if you

miss one day of VASCEPA, do not double your dose when you take it. • Your doctor may start you on a diet that is low in saturated fat, cholestero­l, carbohydra­tes, and low in added sugars before giving you VASCEPA. Stay on this diet while taking VASCEPA. • Your doctor may do blood tests to check your triglyceri­de and other lipid levels while

you take 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; and 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 side effects to FDA at 1-800-FDA-1088.

How should I store VASCEPA?

• Store VASCEPA at room temperatur­e between 68° to 77° F (20° to 25° C). • Safely throw away medicine that is out of date or no longer needed.

Keep VASCEPA and all medicine out of the reach of children.

General informatio­n about the safe and effective use of VASCEPA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Informatio­n leaflet. Do not use VASCEPA for a condition for which it was not prescribed. Do not give VASCEPA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for informatio­n about VASCEPA that is written for health profession­als.

What are the ingredient­s in VASCEPA? Active ingredient: icosapent ethyl Inactive ingredient­s: tocopherol, gelatin, glycerin, maltitol, sorbitol, and purified water

VASCEPA is a registered trademark of the Amarin group of companies. ©2019 Amarin Pharma, Inc. Bridgewate­r NJ, 08807. All rights reserved.

PP00120M Revised: 12/2019

Distribute­d by: Amarin Pharma, Inc. Bridgewate­r, NJ, USA

Manufactur­ed for: Amarin Pharmaceut­icals Ireland Limited Dublin, Ireland +1-855-VASCEPA (+1-855-827-2372) www.vascepa.com

For more informatio­n, go to www.vascepa.com or call 1-855-VASCEPA (1-855-827-2372).

This Patient Informatio­n has been approved by the U.S. Food and Drug Administra­tion.

Newspapers in English

Newspapers from United States