Vascepa 1gm Capsules
It is used to lower triglycerides.It is used in some patients along with other cholesterol drugs to lower the risk of heart attack, stroke, some heart procedures, or the need to go to a hospital for unstable angina (a type of chest pain).
Drug Class
Antihyperlipidemic
Pharmacologic Class
Omega-3 fatty acid derivative
Pregnancy Category
Not available
FDA Approved
Dec 2019
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vascepa is a prescription medicine made from a purified omega-3 fatty acid. It is used along with diet to lower very high levels of triglycerides (a type of fat) in your blood. It is also used to reduce the risk of heart attack, stroke, and certain heart procedures in adults with existing heart disease or diabetes and at least two other risk factors, who also have elevated triglyceride levels.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with food to help your body absorb it properly. Swallow the tablet whole - do not chew, crush, open, or dissolve it. If you have difficulty swallowing, consult your doctor for guidance.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. It's essential to complete the full course of treatment as prescribed.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember, with food. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with food to help your body absorb it properly. Swallow the tablet whole - do not chew, crush, open, or dissolve it. If you have difficulty swallowing, consult your doctor for guidance.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. It's essential to complete the full course of treatment as prescribed.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember, with food. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Continue to follow a heart-healthy diet as recommended by your doctor or dietitian.
- Engage in regular physical activity as advised by your healthcare provider.
- Maintain a healthy weight.
- Limit alcohol intake.
- Quit smoking.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
2 grams orally twice daily with food
Dose Range:
4 - 4 mg
Condition-Specific Dosing:
severeHypertriglyceridemia:
2 grams orally twice daily with food
cardiovascularRiskReduction:
2 grams orally twice daily with food
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No dose adjustment recommended
Dialysis:
No specific recommendations; use with caution due to limited data.
Hepatic Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No dose adjustment recommended
Pharmacology
Mechanism of Action
Icosapent ethyl is an ethyl ester of eicosapentaenoic acid (EPA), an omega-3 fatty acid. Its mechanism of action in reducing cardiovascular events and triglycerides is not fully understood but is thought to involve multiple actions. It reduces hepatic very low-density lipoprotein triglyceride (VLDL-TG) synthesis and secretion and enhances TG clearance from VLDL particles. Other potential mechanisms include anti-inflammatory effects, improved endothelial function, anti-platelet effects, and stabilization of atherosclerotic plaques.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly quantified, but well absorbed
Tmax:
Approximately 5-9 hours (for total EPA)
FoodEffect:
Administration with food increases absorption and exposure (AUC and Cmax) of EPA.
Distribution:
Vd:
Not explicitly reported for icosapent ethyl, but EPA distributes into various tissues.
ProteinBinding:
Highly protein bound (>99%) to plasma proteins.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 89 hours (for total EPA)
Clearance:
Not explicitly reported, but eliminated via metabolic pathways.
ExcretionRoute:
Metabolites are primarily eliminated as carbon dioxide and water.
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Lipid-lowering effects typically observed within weeks.
PeakEffect:
Maximal triglyceride reduction typically seen after several weeks to months of consistent dosing.
DurationOfAction:
Effects persist as long as treatment is continued.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Chest pain or pressure
Fast heartbeat or abnormal heartbeat
Dizziness or fainting
Shortness of breath
Unexplained bruising or bleeding
Swelling in the arms or legs
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Muscle pain
* Constipation
Important Note
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Chest pain or pressure
Fast heartbeat or abnormal heartbeat
Dizziness or fainting
Shortness of breath
Unexplained bruising or bleeding
Swelling in the arms or legs
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Muscle pain
* Constipation
Important Note
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects.
Seek Immediate Medical Attention If You Experience:
- Unusual bleeding or bruising
- Nosebleeds that are frequent or hard to stop
- Blood in urine or stools (black, tarry stools)
- Severe headache or vision changes (may indicate bleeding in the brain)
- Palpitations, shortness of breath, chest discomfort, or dizziness (signs of atrial fibrillation/flutter)
- Severe stomach pain, nausea, or vomiting
- Yellowing of the skin or eyes (jaundice), dark urine, or unusual tiredness (signs of liver problems)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking other medications that contain omega-3 fatty acids, as this may interact with the medication.
All the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
Any existing health problems, as they may affect the safety and efficacy of the medication.
To guarantee your safety, it is vital to:
Discuss all your medications and health problems with your doctor and pharmacist to confirm that it is safe to take this medication.
Avoid starting, stopping, or changing the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking other medications that contain omega-3 fatty acids, as this may interact with the medication.
All the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
Any existing health problems, as they may affect the safety and efficacy of the medication.
To guarantee your safety, it is vital to:
Discuss all your medications and health problems with your doctor and pharmacist to confirm that it is safe to take this medication.
Avoid starting, stopping, or changing the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a known allergy to fish, fish oil, or shellfish, consult with your doctor to discuss potential concerns.
Regular blood work and laboratory tests should be conducted as directed by your doctor. Additionally, adhere to the diet and exercise plan recommended by your doctor to ensure optimal management of your condition.
This medication has been associated with certain types of abnormal heart rhythms, specifically atrial fibrillation or atrial flutter, which can be severe. Individuals with a history of these abnormal heart rhythms are at increased risk. If you experience any symptoms of abnormal heartbeats, notify your doctor promptly.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor. This will enable you to make an informed decision regarding your treatment and the well-being of your baby.
Regular blood work and laboratory tests should be conducted as directed by your doctor. Additionally, adhere to the diet and exercise plan recommended by your doctor to ensure optimal management of your condition.
This medication has been associated with certain types of abnormal heart rhythms, specifically atrial fibrillation or atrial flutter, which can be severe. Individuals with a history of these abnormal heart rhythms are at increased risk. If you experience any symptoms of abnormal heartbeats, notify your doctor promptly.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor. This will enable you to make an informed decision regarding your treatment and the well-being of your baby.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported. High doses may increase the risk of adverse effects such as bleeding or gastrointestinal disturbances.
What to Do:
In case of suspected overdose, contact a poison control center (1-800-222-1222) or seek emergency medical attention immediately. Treatment is supportive.
Drug Interactions
Monitoring
Baseline Monitoring
Lipid Panel (Triglycerides, LDL-C, HDL-C, Total Cholesterol)
Rationale: To establish baseline lipid levels and confirm eligibility for treatment.
Timing: Prior to initiation of therapy
Liver Function Tests (ALT, AST)
Rationale: To establish baseline liver function, as elevations have been observed.
Timing: Prior to initiation of therapy
Routine Monitoring
Lipid Panel (Triglycerides, LDL-C, HDL-C, Total Cholesterol)
Frequency: Periodically (e.g., 3-6 months after initiation, then annually or as clinically indicated)
Target: Goal-directed based on patient's risk factors and guidelines (e.g., triglycerides <150 mg/dL)
Action Threshold: Significant increase in triglycerides or other lipids, or failure to achieve therapeutic goals.
Liver Function Tests (ALT, AST)
Frequency: Periodically (e.g., at 3 months, then annually or as clinically indicated)
Target: Within normal limits or stable
Action Threshold: Persistent elevations of ALT or AST >3 times the upper limit of normal (ULN).
INR/PT (if on anticoagulants)
Frequency: As clinically indicated, especially after initiation or dose changes
Target: Therapeutic range for anticoagulant
Action Threshold: Significant deviation from target range, signs of bleeding.
Symptom Monitoring
- Signs of bleeding (e.g., bruising, petechiae, epistaxis, hematuria, melena)
- Symptoms of atrial fibrillation or flutter (e.g., palpitations, shortness of breath, dizziness, fatigue)
- Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
- Gastrointestinal upset (e.g., diarrhea, nausea, abdominal pain)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of icosapent ethyl in pregnant women. The limited available data on use in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, risk unknown.
Second Trimester:
Limited data, risk unknown.
Third Trimester:
Limited data, risk unknown.
Lactation
There are no data on the presence of icosapent ethyl in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Vascepa and any potential adverse effects on the breastfed infant from Vascepa or from the underlying maternal condition.
Infant Risk:
Unknown; potential for adverse effects on breastfed infant.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Not indicated for use in pediatric patients.
Geriatric Use
No overall differences in safety or effectiveness were observed between patients ≥65 years of age and younger patients. No dose adjustment is necessary based on age alone, but consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Vascepa should be taken with food to optimize absorption.
- Patients should continue to follow a lipid-lowering diet during treatment.
- Monitor for signs of bleeding, especially in patients concurrently taking anticoagulants or antiplatelet agents.
- Atrial fibrillation or flutter has been reported in clinical trials, particularly in patients with a history of AFib or heart failure. Monitor for symptoms.
- Liver enzyme elevations (ALT/AST) have been observed; periodic monitoring is recommended.
- Vascepa is specifically purified EPA ethyl ester and is not interchangeable with other omega-3 fatty acid products (e.g., fish oil supplements) due to differences in composition and purity.
Alternative Therapies
- Statins (e.g., atorvastatin, rosuvastatin) - primary agents for LDL-C lowering and CV risk reduction.
- Fibrates (e.g., fenofibrate, gemfibrozil) - primarily for triglyceride lowering.
- Niacin (nicotinic acid) - for triglyceride and LDL-C lowering, HDL-C raising.
- Other omega-3 fatty acid products (e.g., Lovaza, Epanova, Omtryg) - for severe hypertriglyceridemia, but not indicated for CV risk reduction.
- PCSK9 inhibitors (e.g., evolocumab, alirocumab) - for severe hypercholesterolemia and CV risk reduction.
- Bempedoic acid - for LDL-C lowering.
- Inclisiran - for LDL-C lowering.
Cost & Coverage
Average Cost:
$300 - $450 per 120 capsules (1 month supply)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Specialty Drug)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.