"June 10, 2015 -- A new class of medications can lower "bad" LDL cholesterol to unheard-of levels, and it may be on the horizon.
The new class is called PCSK9 inhibitors. An FDA advisory panel on Tuesday recommended that the agency approve t"...
(icosapent ethyl) Capsules
Read this Patient Information before you start taking VASCEPA and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is VASCEPA?
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.
Who should not take VASCEPA?
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.
What should I tell my doctor before taking VASCEPA?
Before you take VASCEPA, tell your doctor 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 non-prescription 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).
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
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.
- You should not take more than 4 capsules of VASCEPA each day. Do not take more capsules than what is prescribed by your doctor.
- 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.
This is not the only side effect of VASCEPA. For more information, ask your doctor or pharmacist.
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 Patient Information Leaflets. 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 you have. It may harm them.
This Patient Information summarizes the most important information about VASCEPA. If you would like more information, talk with your doctor or pharmacist. You can ask your doctor or pharmacist for information about VASCEPA that is written for health professionals.
For more information, go to www.vascepa.com or call 1-855-VASCEPA (1-855-827-2372).
What are the ingredients in VASCEPA?
Active Ingredient: icosapent ethyl
Inactive Ingredients: tocopherol, gelatin, glycerin, maltitol, sorbitol, and purified water
This patient information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 9/30/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Vascepa Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Tips to keep it under control.