INDICATION AND IMPORTANT SAFETY INFORMATION
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.
- 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 is safe and effective in children.
IMPORTANT SAFETY INFORMATION
WHO SHOULD NOT TAKE VASCEPA?
- Do not take VASCEPA if you are allergic to icosapent ethyl or any of the ingredients in 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
- 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.
Tell your doctor if you take medicines that affect your blood clotting (anticoagulants or blood thinners).
For more information on VASCEPA, click here to see the full Patient Information or call 1-855-VASCEPA (1-855-827-2372).