Patient Medication Information: uses, side effects, how to take - Vascepa
What is VASCEPA used for?
VASCEPA is used to lower your risk of:
- dying from heart disease
- having a heart attack or stroke
- having certain types of heart surgery or
- having to be hospitalized for unstable angina (a condition in which your heart does not get enough blood flow and oxygen)
It is used in adults who have high levels of triglycerides (a type of fat found in your blood), are currently taking cholesterol-lowering medications called statins and who are at a high risk of experiencing heart related problems due to:
- an existing heart condition, or
- diabetes and at least one other heart-related problem
How does VASCEPA work?
VASCEPA contains a type of omega-3-fatty acid from fish oil called eicosapentaenoic acid (EPA). Exactly how VASCEPA works is not known. It does help lower the amount of triglycerides made by your body.
What are the ingredients in VASCEPA?
Medicinal ingredients: icosapent ethyl
Non-medicinal ingredients: gelatin, glycerin, hypromellose, maltitol, propylene glycol, purified water, sorbitol, titanium dioxide, and tocopherol
VASCEPA comes in the following dosage forms:
Capsule: 1 g
Do not use VASCEPA if:
- If you are allergic to icosapent ethyl or any of the other ingredients in VASCEPA (see Non-medicinal ingredients above).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take VASCEPA. Talk about any health conditions or problems you may have, including if you:
- are allergic to fish or shellfish.
- are taking other omega-3 fatty acid products. Do not take other omega-3 fatty acid products while you are taking VASCEPA.
- are taking medicines to reduce the formation of blood clots (anticoagulants, or anti‐platelet medications, including aspirin). If so, you may be at increased risk of bleeding. Your doctor should monitor you if you are taking VASCEPA with these types of medications.
- have liver problems. Your doctor may perform blood tests to monitor you.
- have a medical history of problems with irregular heartbeat (atrial fibrillation or flutter).
if you are pregnant or planning to become pregnant. It is not known if VASCEPA will harm your unborn baby. You should not take VASCEPA while pregnant.
- If you are breastfeeding or planning to breastfeed. VASCEPA may pass into your breast milk and may harm your baby. You should not take VASCEPA if you are breastfeeding.
Other warnings you should know about:
Testing and Check Ups
Your doctor may do blood tests to check your triglyceride and other lipid levels while you take VASCEPA.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with VASCEPA:
- other omega-3 fatty acids
- medicines to reduce the formation of blood clots (anticoagulants, anti-platelet medications, including aspirin)
How to take VASCEPA:
- Take as directed by your healthcare professional.
- Take it with your meals
- Swallow capsules whole. Do not break, crush, dissolve, or chew the capsules before swallowing.
- Your healthcare professional will discuss with you proper diet and exercise before you start treatment with VASCEPA.
Usual adult dose: Take 2 capsules twice a day.
Overdose:
Signs of an overdose with VASCEPA include:
- stomach problems
- bleeding
- abnormal heart beat
| If you think you, or a person you are caring for, have taken too much VASCEPA, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
- If you miss a dose, take it as soon as you remember
- If you miss taking VASCEPA for one day, do not double your dose when you take your next dose.
What are possible side effects from using VASCEPA?
These are not all the possible side effects you may feel when taking VASCEPA. If you experience any side effects not listed here, contact your healthcare professional.
Side effects include:
- Constipation
- Gout
- Muscle and joint pain
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| COMMON | |||
| Swelling (edema): of hands, feet, ankles, and lower legs | ✔ | ||
| Irregular heart beat (atrial fibrillation and atrial flutter): feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, chest discomfort, or you faint. | ✔ | ||
| Bleeding: unusual bleeding and increased risk of bleeding if taking blood thinners. | ✔ | ||
| Allergic Reactions: difficulty swallowing or breathing, wheezing; drop in blood pressure; feeling sick to your stomach and throwing up; hives or rash; swelling of the face, lips, tongue or throat. | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store at room temperature (20° to 25°C) in the original container. Keep out of reach and sight of children.
If you want more information about VASCEPA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website https://www.vascepa.ca, or by calling 1-833-266-3423.