Pronunciation:

eye-KOE-sa-pent ETH-il

Brand Names:

• Vascepa

Dosage Forms:

• Capsule, Liquid Filled

Classifications:

Therapeutic—

Antihyperlipidemic

Chemical—

Omega-3 Fatty Acid

Uses of This Medicine:

Icosapent ethyl is used together with a proper diet to help control high triglyceride (fat-like substance) levels in the blood. This medicine is also used together with a statin medicine to lower the risk of heart attack, stroke, and certain heart problems requiring hospitalization in adults with heart or blood vessel disease or diabetes.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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

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.

Other 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.

Other interactions—

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.

• Bleeding problems or
• Heart rhythm problems (eg, atrial fibrillation, atrial flutter)—Use with caution. May make these conditions worse.

• 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.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not change or stop taking this medicine without first checking with your doctor.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Swallow the capsule whole. Do not crush, break, chew, dissolve, or open it. Take this medicine with food.

Before prescribing medicine for your condition your doctor will probably try to control your condition by prescribing a personal diet for you. Carefully follow the special diet your doctor gave you. This diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is most effective when used in combination with diet and exercise.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For high triglycerides or fats in the blood:
    • Adults—4 grams per day, to be taken as four 0.5 gram capsules two times a day with food, or as two 1 gram capsules two times a day with food.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may increase your risk of heart rhythm problems (eg, atrial fibrillation, atrial flutter). Call your doctor right away if you feel dizzy or faint, or have a fast, pounding, or uneven heartbeat.

This medicine may increase your chance of bleeding. To help with this problem, stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Tell your doctor if you drink alcohol. Alcohol intake may cause lipid (fat-like substance) disorders.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Dizziness

fainting

fast or irregular heartbeat

lightheadedness

swelling of the hands, ankles, feet, or lower legs

unusual bleeding

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Constipation

difficulty with moving

muscle pain or stiffness

pain in the joints

pain in the mouth or throat

Incidence not known

Diarrhea

pain in the arms or legs

stomach discomfort

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.