Vascepa

VASCEPA
(vas-EE-puh)
(icosapent ethyl) Capsules

What is VASCEPA?

VASCEPA is a prescription medicine used along with a low-fat and low-cholesterol 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 prevents you from having a heart attack or stroke.

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 leaflet 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 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-the-counter 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.
  • If you are prescribed the 1 gram capsules, you should not take more than 4 capsules per day.
• 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?

If you have liver problems and are taking VASCEPA, your doctor should do blood tests during treatment. The most common side effect of VASCEPA is joint pain. As with all drugs, you may experience a serious side effect when taking VASCEPA. Talk to your doctor if you have a side effect that bothers you or does not go away.

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

Icosapent is used together with a low-fat diet and other treatments to lower total cholesterol in people with severe high cholesterol.

Before you take icosapent, tell your doctor if you have liver disease, diabetes, a thyroid disorder, pancreas problems, a bleeding or blood-clotting disorder, an allergy to fish or shellfish, or if you drink large quantities of alcohol.

Icosapent is only part of a treatment program that may also include diet, exercise, and weight control. Follow your doctor's instructions very closely.

• 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.

Icosapent works in the liver and bloodstream to reduce very low-density triglycerides.

Icosapent is used together with a low-fat and low-cholesterol diet to reduce triglycerides (fats) in adults with severely high triglycerides.

It is not known whether icosapent will lower your risk of developing heart disease or pancreatitis (inflammation of your pancreas).

Icosapent may also be used for purposes not listed in this medication guide.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Antilipemic agent; an ethyl ester of eicosapentaenoic acid (EPA).1 3 4 5 10 11

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of icosapent ethyl in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of icosapent ethyl in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to fish or shellfish, history of—May have an increase risk of an allergic reaction to this medicine.

• Diabetes or
• Hypothyroidism (underactive thyroid)—Use with caution. Your doctor will tell you how to control these conditions that may cause lipid (fat) disorders.

• Liver problems—Your doctor may want to monitor you more closely for unwanted effects.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Vascepa does not have any known drug abuse or withdrawal effects.

Information for Patients

Vascepa should be used with caution in patients with known sensitivity or allergy to fish and/or shellfish [see Warnings and Precautions (5.2)].

Patients should be advised that use of lipid-regulating agents does not reduce the importance of appropriate nutritional intake and physical activity [see Dosage and Administration (2)].

Patients should be advised not to alter Vascepa capsules in any way and to ingest intact capsules only [see Dosage and Administration (2)].

Instruct patients to take Vascepa as prescribed. If a dose is missed, patients should take it as soon as they remember. However if they miss one day of Vascepa, they should not double the dose when they take it.

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

Manufactured for:
Amarin Pharmaceuticals Ireland Limited
Dublin, Ireland
+1-855-Vascepa (+1-855-827-2372)

www.Vascepa.com

Vascepa is a registered trademark of the Amarin group of companies

©2016 Amarin Pharma, Inc. Bedminster NJ 07921 All rights reserved

P00120K
2/2017

You should not use Vascepa if you are allergic to icosapent.

To make sure Vascepa is safe for you, tell your doctor if you have:

• liver disease;

• diabetes;

• a thyroid disorder;

• problems with your pancreas;

• a bleeding or blood-clotting disorder;

• if you are allergic to fish or shellfish; or

• if you drink large amounts of alcohol.

It is not known whether Vascepa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Icosapent can pass into breast milk, but effects on the nursing baby are not known. Tell your doctor if you are breast-feeding.

Vascepa is not approved for use by anyone younger than 18 years old.

Usual Adult Dose for Hypertriglyceridemia:

4 grams per day taken as 2 capsules orally twice daily with food

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.