Icosapent ethyl (Oral)

Icosapent ethyl (Oral) is used along with a proper diet to help manage high triglyceride levels in the blood. This medicine is also used with a statin medicine to reduce the risk of heart attack, stroke, and certain heart issues that may need hospitalization in adults who have heart or blood vessel disease or diabetes.

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

It is very important that your doctor checks your progress at regular visits to make sure 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 (for example, 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, avoid rough sports or other situations where you could get 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 you have discussed them 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.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine versus the benefits it may provide. For this medicine, keep the following points in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know 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

There have not been appropriate studies on how icosapent ethyl affects children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of icosapent ethyl.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

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

• Bleeding problems or
• Heart rhythm problems (e.g., atrial fibrillation, atrial flutter)—Use with caution. May worsen these conditions.

• Diabetes or
• Hypothyroidism (underactive thyroid)—Use with caution. Your doctor will guide you on how to manage these conditions that may lead to lipid (fat) disorders.

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

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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 happen in some patients. If you notice any other effects, check with your health care professional.

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

In the U.S.

• Vascepa

Available Dosage Forms:

• Capsule, Liquid Filled

Therapeutic Class: Antihyperlipidemic

Chemical Class: Omega-3 Fatty Acid

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.

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