Table of Contents

• What is VASCEPA?
• Constituents
• Indications
• How does VASCEPA work?
• How to Take VASCEPA?
• Common Dosage for VASCEPA
• When to Avoid VASCEPA?
• Side-effects of VASCEPA
• Effects on organs
• Warnings and Precautions if any
• Reported Allergic Reactions
• Effect of VASCEPA on the menstrual cycle
• Drug Interactions To Be Careful About
• Food interactions
• Interactions with laboratory procedures
• Shows Effects / Results In and how long does the effect stay
• Is VASCEPA Addictive?
• Can I have VASCEPA with alcohol?
• Can I have VASCEPA When Pregnant?
• Can I have VASCEPA when feeding a baby?
• Can I drive after taking VASCEPA?
• Effect of overdose of VASCEPA
• Effect of using expired VASCEPA
• Effect of missing a dose of VASCEPA
• Storage requirements
• Substitutes for VASCEPA

What is VASCEPA?

Vascepa is a fish-oil based drug prescribed in patients who are at risk of getting heart stroke, heart attack and other cardiovascular diseases due to high cholesterol levels. Vascepa is prescribed along with statin therapy for patients having high levels of triglycerides (Hypertriglyceridemia). It is a prescription medicine and is not available over the counter.

This drug is U.S FDA approved in 2012 and distributed by Amarin Pharmaceuticals, USA.

It is the second fish oil-based medication in the USA. The first one is Lovaza. FDA approved Vascepa as the first drug which can reduce cardiovascular risks in patients with high triglyceride levels.

Other brand names available are OMARCOR, LOVAZA, and OMTRYG

EPANOVA is another drug but its supply is discontinued in the USA.

Constituents

The main ingredient in Vascepa capsule is a highly purified form of ethyl ester of eicasopentanoic acid or ethyl icosapent. It is a type of omega-3 fatty acid found in fish oil.

Indications

• As an adjuvant drug for patients with very high triglyceride levels (>500mg per deciliter) along with a well-controlled diet and exercise.
• To prevent cardiovascular events like heart stroke, attack, myocardial ischemia in patients with hypertriglyceridemia (>150mg/dl) who are at risk of developing heart diseases.
•  It is also indicated for some mental conditions like Alzheimer’s disease, ADHD, schizophrenia, personality disorder and depression.
• For some age-related eye problems like macular degeneration. The usage of Vascepa for eye problems is still under clinical research.
• To treat the symptoms of menopause.

The indications listed here are for informational purposes only. Your doctor may or may not suggest Vascepa for the conditions listed. Please follow the instructions of your healthcare provider.

How does VASCEPA work?

Vascepa reduces the production of triglycerides in the liver and increases the elimination of triglycerides from circulation. The exact mechanism of action is not clear, but it is known to increase the breakdown of fatty acids, inhibit the enzyme Diacylglycerol acyltranferase in the pathway of biosynthesis of triglycerides in the liver.

Biosynthesis of triglycerides in the liver:

DGAT enzyme is the site where VASCEPA works.²

How to Take VASCEPA?

It is usually prescribed twice daily with food. Do not crush or chew the capsule. Take it as a whole with water or any liquid. It is advised to take Vascepa along with appropriate physical activity and a well-controlled diet.

Common Dosage for VASCEPA

• It is available as 0.5gm and 1gm soft gelatin capsules.
• The usual dose is 4gm per day for Hypertriglyceridemia along with statins. It can be taken as 4 capsules of 0.5gm per dose or 2capsules of 1gm per dose.
• For patients with cardiovascular risks, the usual dose is 0.6gms three times per day. If you are taking medications for high blood pressure, concomitant usage might lower blood pressure.
• For patients with depression: 0.5-1gm twice or thrice daily is the usual prescribed dose along with anti-depressants.
• For menopausal symptoms: 0.5gm three times daily is the usual prescribed dose.

When to Avoid VASCEPA?

• It should be avoided in patients who are allergic to Vascepa or Icosapent ethyl.
• It is not known whether it is contraindicated in patients who are allergic to seafood. It is good to discuss with your doctor before taking this medicine if you are allergic to any kind of seafood.
• It should be used with caution in patients with liver diseases.

Side-effects of VASCEPA

Vascepa can show the following side effects in some people thought it is well tolerated by most of the people. Side effects may vary from person to person. Here is the list of side effects.

• Nausea
• Diarrhea
• Gastric pain
• Skin rash
• Bleeding from the nose
• Joint pains
• Muscle pains
• Fishy taste can cause nausea and belching.
• Peripheral edema.

Please contact your doctor immediately if you observe any of the symptoms above. Follow the dosage instructions properly to avoid the risk of overdosage and adverse reactions mentioned above.

Effects of VASCEPA on organs

• Joint pain is the most common side effect of this medicine.
• Effects of Vascepa on the Liver: The effects on the liver have not been studied yet. The patients with liver diseases should be monitored for the levels of AST and ALT during the therapy with Vascepa.

Warnings and Precautions

• Atrial Flutter/ Fibrillation: There is a risk of atrial fibrillation in patients taking Vascepa. Patients with a known history of atrial fibrillation are at increased risk of recurrence.
• Allergies to fish and shellfish: Patients with known allergies to fish and shellfish should avoid this medicine. Please let your doctor know if you have any allergies to fish, shellfish or any other foods.
• There is an increased risk of bleeding while taking Vascepa. In people taking antithrombin drugs like Aspirin, Clopidogrel, Warfarin, the risk of abnormal bleeding is greater than in normal people.

Reported Allergic Reactions

Allergic reactions have been reported in patients who are allergic to icosapent ethyl, which is the main ingredient in Vascepa and also in people who are allergic to fish and shellfish.

Effect of VASCEPA on the menstrual cycle

The effect on menstrual cycles is unknown. Please consult your gynecologist before taking this medication.

Drug Interactions to Be Careful About

Anti-coagulants and Anti-platelet drugs: Concomitant use of Vascepa along with these drugs may increase the risk of bleeding.

Let your doctor know if you are taking any of the following drugs:

• Argatroban, Bivalirudin, Dabigatran, Fondaparinux,
• Abciximab, Tirofiban
• Enoxaparin, Dalteparin
• Clopidrogel, Ticlopidine
• Urokinase, Alteplase
• Blood-thinning agents like Warfarin, Coumadin.
• Birth control pills and hormone replacement therapy.

This list may not include all the drugs which interfere with the effects and metabolism of Vascepa. Please carry the prescriptions, if you are on any long term therapies and let your doctor know if you are allergic to any drugs.

Food interactions

There is no clinical evidence of food interactions with Vascepa. Therefore it is safe to take Vascepa along with any food.

Interactions with laboratory procedures

Interactions with laboratory procedures were not determined in the clinical studies.

Shows Effects / Results in and how long does the effect stay

It takes approximately 5 hours to show its effect. It is metabolized in the liver. The effects of the single-dose may stay up to 3-4 days.

Is VASCEPA Addictive?

This drug is not addictive. No evidence of drug dependence and withdrawal symptoms were found.

Can I have VASCEPA with alcohol?

Vascepa is effective only when the strict diet is followed. Foods with high cholesterol and alcohol should be avoided.

Can I have VASCEPA When Pregnant?

US F.D.A Pregnancy Category C: The effects of Vascepa on the fetus in humans are not known. It is suggested to use this drug during pregnancy only if the benefits outweigh the risks. Consult your obstetrician before taking this medication.

Can I have VASCEPA when feeding a baby?

It is excreted into breast milk. The safety of this drug in nursing mothers is not established. Notify your doctor if you are breast feeding or donating/sharing your breast milk to feed premature babies or infants.

Can I drive after taking VASCEPA?

It is safe to drive after taking this medication.

Effect of an overdose of VASCEPA

The overdosage of Vascepa may cause undesired effects. Please contact your doctor immediately and seek emergency medical attention if you have taken excess doses of Vascepa.

Effect of using expired VASCEPA

Expired Vascepa may not show intended benefits. Please check the manufacturing date before purchasing the drug. If you have expired drugs at home, throw away by following the guidelines for disposal on the label or please follow the instructions of your healthcare provider.

Effect of missing a dose of VASCEPA

Missing a single dose may not cause any effect. But if you are missing doses frequently, it may not show intended benefits. Use the missed dose sooner you recall. If it is close to the next dose, skip the missed dose and take the regular dose.

Storage requirements

• It should be stored under room temperature
• Keep it away from reach of children
• Keep it away from reach of pets
• It should not be kept in a moist environment

Substitutes for VASCEPA

• Lovaza is another similar prescription based fish oil medicine that contains both EPA and DHA.
• However, there are no generic alternatives to Vascepa available in the USA.

References:

1. https://www.acc.org/latest-in-cardiology/articles/2019/12/16/16/41/fda-approves-vascepa-to-reduce-cardiovascular-risk
2. https://www.lipidhome.co.uk/lipids/simple/tag2/index.htm

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