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

Vascepa is used together with other medicines (such as statins) to reduce the risk of heart attack, stroke, and some types of heart problems that need hospitalization in adults.

Vascepa 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 Vascepa will lower your risk of pancreatitis (inflammation of your pancreas).

Before you take Vascepa, 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.

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

Before taking this medicine

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 ever had:

• liver disease;

• diabetes;

• a thyroid disorder;

• problems with your pancreas;

• a bleeding or blood-clotting disorder; or

• if you are allergic to fish or shellfish.

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

Icosapent can pass into breast milk, and may harm your baby. Tell your doctor if you are breastfeeding.

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

Vascepa is usually taken 2 times per day. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take with food.

Swallow the capsule whole and do not crush, chew, break, or open it.

You will need frequent blood tests.

Vascepa is only part of a complete treatment program that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Hypertriglyceridemia:

2 g orally twice a day with food

Comments:
-Patients should be placed on an appropriate lipid-lowering diet and exercise regimen before initiating therapy and should continue this diet and exercise regimen during therapy.

Uses:
-As an adjunct to diet to reduce triglyceride (TG) levels in patients with severe (500 mg/dL or greater) hypertriglyceridemia.
-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 triglyceride levels of 150 mg/dL or higher and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.

Usual Adult Dose for Cardiovascular Risk Reduction:

2 g orally twice a day with food

Comments:
-Patients should be placed on an appropriate lipid-lowering diet and exercise regimen before initiating therapy and should continue this diet and exercise regimen during therapy.

Uses:
-As an adjunct to diet to reduce triglyceride (TG) levels in patients with severe (500 mg/dL or greater) hypertriglyceridemia.
-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 triglyceride levels of 150 mg/dL or higher and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.

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 ever had:

• liver disease;

• diabetes;

• a thyroid disorder;

• problems with your pancreas;

• a bleeding or blood-clotting disorder; or

• if you are allergic to fish or shellfish.

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

Icosapent can pass into breast milk, and may harm your baby. Tell your doctor if you are breastfeeding.

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

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Avoid eating foods that are high in fat or cholesterol. Vascepa will not be as effective in lowering your cholesterol if you do not follow a cholesterol lowering diet plan.

Get emergency medical help if you have signs of an allergic reaction to Vascepa: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fast or irregular heartbeats, dizziness, shortness of breath, chest discomfort, fainting, or if you feel light-headed; or

• serious bleeding.

Common Vascepa side effects may include:

• muscle or joint pain;

• constipation;

• swelling of the hands, legs, or feet.

• gout; or

• chest pressure, racing or pounding heartbeats, fluttering in your chest, feeling short of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• a blood thinner - warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may interact with icosapent, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.