Vascepa 0.5gm 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, Cardiovascular agent
Pharmacologic Class
Omega-3 fatty acid, Triglyceride lowering agent
Pregnancy Category
Not available
FDA Approved
Jul 2012
DEA Schedule
Not Controlled
Overview
What is this medicine?
Icosapent ethyl is a purified omega-3 fatty acid (a type of fat found in fish oil) that helps 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 other heart problems in people who already have heart disease or are at high risk, and who are also taking statin medication.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to 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 crucial to complete the full course of treatment to ensure the best possible outcome.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets. Dispose of unused or expired medications responsibly. 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 or 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, it's essential to 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 crucial to complete the full course of treatment to ensure the best possible outcome.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets. Dispose of unused or expired medications responsibly. 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 or 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
- Take Vascepa with food, as directed by your doctor. It is important to take it consistently with meals.
- Continue to follow a heart-healthy diet (low in saturated fat and cholesterol) as recommended by your doctor or dietitian.
- Engage in regular physical activity as advised by your healthcare provider.
- If you miss a dose, take it as soon as you remember with food. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
- Do not stop taking Vascepa without talking to your doctor, even if you feel well.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
4 grams orally per day, taken as two 0.5-gram capsules twice daily with food, or four 0.5-gram capsules twice daily with food.
Dose Range:
4000 - 4000 mg
Condition-Specific Dosing:
severeHypertriglyceridemia:
4 grams orally per day, taken as two 0.5-gram capsules twice daily with food, or four 0.5-gram capsules twice daily with food.
cardiovascularRiskReduction:
4 grams orally per day, taken as two 0.5-gram capsules twice daily with food, or four 0.5-gram capsules 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, but monitor for adverse effects.
Dialysis:
No specific recommendations; use with caution and monitor.
Hepatic Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
No dose adjustment recommended, but monitor for adverse effects.
Pharmacology
Mechanism of Action
Icosapent ethyl is an ethyl ester of eicosapentaenoic acid (EPA), an omega-3 fatty acid. Its exact mechanism of action in reducing triglycerides and cardiovascular risk is not fully understood but is thought to involve multiple mechanisms, including inhibition of diacylglycerol acyltransferase, increased hepatic beta-oxidation, and reduced hepatic synthesis of triglycerides. It also reduces very low-density lipoprotein (VLDL) production and enhances VLDL clearance. Additionally, it may have anti-inflammatory, anti-thrombotic, and endothelial function-improving effects.
Pharmacokinetics
Absorption:
Bioavailability:
Not directly quantified, but well absorbed.
Tmax:
Approximately 5-9 hours for peak plasma EPA concentrations.
FoodEffect:
Absorption is significantly increased when taken with a high-fat meal.
Distribution:
Vd:
Approximately 89 liters (for EPA).
ProteinBinding:
Greater than 99% bound to plasma proteins.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 89 hours (for EPA).
Clearance:
Not specifically quantified as a single rate, but eliminated via metabolic pathways.
ExcretionRoute:
Metabolites primarily excreted via respiration (as CO2) and feces.
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Triglyceride lowering effects typically observed within weeks.
PeakEffect:
Maximum triglyceride reduction usually seen after several weeks 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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious reaction:
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 do not experience any side effects or 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
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious reaction:
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 do not experience any side effects or 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
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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.
Seek Immediate Medical Attention If You Experience:
- Unusual bleeding or bruising (e.g., nosebleeds, bleeding gums, blood in urine or stools, dark or tarry stools)
- Chest pain, shortness of breath, or rapid/irregular heartbeat (signs of atrial fibrillation/flutter)
- Sudden, severe joint pain and swelling (signs of gout)
- Yellowing of the skin or eyes, dark urine, or persistent nausea/vomiting (signs of liver problems)
- Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
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, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking other medications that contain omega-3 fatty acids, as this may interact with the medication.
All medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and minimize potential interactions.
Any existing health problems you have, as they may affect the safety and efficacy of the medication.
To guarantee your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dosage 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, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking other medications that contain omega-3 fatty acids, as this may interact with the medication.
All medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and minimize potential interactions.
Any existing health problems you have, as they may affect the safety and efficacy of the medication.
To guarantee your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dosage 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 heartbeats are at increased risk. Notify your doctor if you have experienced these conditions in the past.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is crucial to discuss the benefits and risks of this medication with your doctor, as this will help determine the best course of treatment for you and 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 heartbeats are at increased risk. Notify your doctor if you have experienced these conditions in the past.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is crucial to discuss the benefits and risks of this medication with your doctor, as this will help determine the best course of treatment for you and your baby.
Overdose Information
Overdose Symptoms:
- Increased risk of bleeding
- Gastrointestinal upset (nausea, diarrhea)
What to Do:
In case of overdose, call your poison control center at 1-800-222-1222. Seek immediate medical attention if symptoms are severe.
Drug Interactions
Monitoring
Baseline Monitoring
Fasting Triglycerides
Rationale: To establish baseline and assess treatment efficacy.
Timing: Prior to initiation of therapy.
LDL-C, HDL-C, Total Cholesterol
Rationale: To assess overall lipid profile and guide concomitant lipid-lowering therapy.
Timing: Prior to initiation of therapy.
Liver Transaminases (ALT, AST)
Rationale: To establish baseline and monitor for potential hepatic adverse effects.
Timing: Prior to initiation of therapy.
Routine Monitoring
Fasting Triglycerides
Frequency: Periodically (e.g., 3-6 months after initiation, then annually or as clinically indicated).
Target: Goal-dependent (e.g., <150 mg/dL for hypertriglyceridemia, or reduction from baseline for CV risk).
Action Threshold: Lack of adequate response or significant increase.
Liver Transaminases (ALT, AST)
Frequency: Periodically (e.g., annually or as clinically indicated).
Target: Within normal limits.
Action Threshold: Persistent elevations >3 times the upper limit of normal (ULN); consider dose reduction or discontinuation.
INR/PTT (if on anticoagulants)
Frequency: As clinically indicated, more frequently upon initiation or dose changes.
Target: Therapeutic range for anticoagulant.
Action Threshold: INR/PTT outside target range, or signs of bleeding.
Symptom Monitoring
- Signs of bleeding or bruising (e.g., nosebleeds, gum bleeding, petechiae, hematoma, melena)
- Symptoms of atrial fibrillation or flutter (e.g., palpitations, shortness of breath, chest discomfort, dizziness)
- Symptoms of gout (e.g., acute joint pain, swelling, redness)
- Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Vascepa in pregnant women. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown.
Trimester-Specific Risks:
First Trimester:
Not specifically studied; potential risks unknown.
Second Trimester:
Not specifically studied; potential risks unknown.
Third Trimester:
Not specifically studied; potential risks unknown.
Lactation
It is unknown whether icosapent ethyl is excreted in human milk. 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. Consult with a healthcare provider.
Infant Risk:
Not available; potential risk unknown.
Pediatric Use
Safety and effectiveness of Vascepa have not been established in pediatric patients for either severe hypertriglyceridemia or cardiovascular risk reduction.
Geriatric Use
No overall differences in effectiveness or safety were observed between patients ≥65 years of age and younger patients. However, older patients may be more susceptible to adverse effects, particularly bleeding, and should be monitored closely.
Clinical Information
Clinical Pearls
- Vascepa is not interchangeable with other omega-3 fatty acid products (e.g., fish oil supplements) due to its specific formulation and purification of EPA.
- Always take Vascepa with food to ensure optimal absorption.
- Patients on anticoagulants or antiplatelet agents should be monitored for increased bleeding risk.
- There is an increased risk of atrial fibrillation or flutter in patients treated with icosapent ethyl, particularly in those with a history of these conditions.
- Icosapent ethyl can increase LDL-C levels in some patients, which should be monitored.
- Gout has been reported as an adverse reaction; monitor for symptoms.
Alternative Therapies
- Other omega-3 fatty acid products (e.g., Lovaza, Omtryg - for hypertriglyceridemia, but not for CV risk reduction in statin-treated patients)
- Fibrates (e.g., fenofibrate, gemfibrozil - for hypertriglyceridemia)
- Statins (e.g., atorvastatin, rosuvastatin - primarily for LDL-C lowering, but also have some triglyceride-lowering effects)
- PCSK9 inhibitors (e.g., evolocumab, alirocumab - primarily for LDL-C lowering)
- Bempedoic acid (for LDL-C lowering)
- Ezetimibe (for LDL-C lowering)
Cost & Coverage
Average Cost:
Varies widely, typically $300-$500+ per 120 capsules (0.5gm)
Generic Available:
Yes
Insurance Coverage:
Often Tier 3 (non-preferred brand) or specialty drug, may require prior authorization.
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, including the amount and time of ingestion.