Icosapent Ethyl 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, Cardiovascular agent
Pharmacologic Class
Omega-3 fatty acid, Eicosapentaenoic acid (EPA) derivative
Pregnancy Category
Not available
FDA Approved
Jul 2012
DEA Schedule
Not Controlled
Overview
What is this medicine?
Icosapent ethyl is a prescription medicine made from a purified omega-3 fatty acid found in fish oil. It is used along with a healthy diet to lower very high triglyceride (a type of fat) levels in your blood. It is also used in people with heart disease or diabetes with other risk factors to reduce the risk of heart attack, stroke, and other heart problems, when added to statin therapy.
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.
- Avoid excessive alcohol consumption.
- If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take two doses at once.
- Take with food to improve absorption and reduce gastrointestinal upset.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
2 grams orally twice daily with food (total 4 grams/day)
Dose Range:
4000 - 4000 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 dosage adjustment necessary
Moderate:
No dosage adjustment necessary
Severe:
No dosage adjustment necessary
Dialysis:
No dosage adjustment necessary; Icosapent ethyl is not significantly removed by hemodialysis.
Hepatic Impairment:
Mild:
No dosage adjustment necessary
Moderate:
No dosage adjustment necessary
Severe:
No dosage adjustment necessary
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 cardiovascular events and triglyceride levels is not fully understood but is thought to involve multiple actions. These include inhibition of diacylglycerol acyltransferase, increased beta-oxidation, reduced hepatic VLDL-TG synthesis, and increased plasma triglyceride clearance. It may also have anti-inflammatory, anti-thrombotic, and endothelial function-improving effects.
Pharmacokinetics
Absorption:
Bioavailability:
Not directly quantified, but well absorbed after oral administration.
Tmax:
Approximately 5-9 hours for total EPA
FoodEffect:
Absorption is increased when taken with food, particularly a high-fat meal. Must be taken with food.
Distribution:
Vd:
Not available
ProteinBinding:
Greater than 99% bound to plasma proteins
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 89 hours (for total EPA)
Clearance:
Not available
ExcretionRoute:
Metabolized and eliminated as carbon dioxide and water; minimal excretion of unchanged drug.
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Triglyceride lowering effects typically observed within weeks.
PeakEffect:
Maximal triglyceride reduction typically observed after 3-6 months of consistent therapy.
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 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
Note: This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, consult 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 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
Note: This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, consult 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 (e.g., nosebleeds, bleeding gums, blood in urine or stool)
- Swelling in your hands, ankles, or feet (peripheral edema)
- New or worsening joint pain (arthralgia)
- Symptoms of gout (sudden, severe joint pain, redness, swelling, tenderness)
- Symptoms of atrial fibrillation (palpitations, shortness of breath, dizziness, chest discomfort)
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 (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
Any existing health problems you have, as they may affect the safety and efficacy of the medication.
To guarantee your safety, always consult with your doctor before starting, stopping, or changing the dose of any medication. Your doctor and pharmacist need to be aware of all your medications and health issues to verify that it is safe for you to take this medication in conjunction with your other treatments.
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 (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
Any existing health problems you have, as they may affect the safety and efficacy of the medication.
To guarantee your safety, always consult with your doctor before starting, stopping, or changing the dose of any medication. Your doctor and pharmacist need to be aware of all your medications and health issues to verify that it is safe for you to take this medication in conjunction with your other treatments.
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. If you experience any symptoms of abnormal heart rhythms, 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 heartbeats are at increased risk. If you experience any symptoms of abnormal heart rhythms, 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.
What to Do:
In case of suspected overdose, contact a poison control center (1-800-222-1222) or seek emergency medical attention. Treatment should be symptomatic and supportive.
Drug Interactions
Monitoring
Baseline Monitoring
Triglyceride levels
Rationale: To confirm diagnosis of severe hypertriglyceridemia or elevated triglycerides in patients with established CVD or diabetes with risk factors.
Timing: Prior to initiation of therapy
LDL-C, HDL-C, Total Cholesterol
Rationale: To assess overall lipid profile and ensure patient is on maximally tolerated statin therapy if indicated.
Timing: Prior to initiation of therapy
Liver function tests (ALT, AST)
Rationale: To establish baseline liver function, although hepatic impairment is not a contraindication.
Timing: Prior to initiation of therapy
Routine Monitoring
Triglyceride levels
Frequency: Periodically (e.g., 3-6 months after initiation, then annually or as clinically indicated)
Target: <150 mg/dL (for risk reduction), or significant reduction from baseline (for severe hypertriglyceridemia)
Action Threshold: Lack of adequate response or worsening levels may require re-evaluation of therapy or adherence.
Liver function tests (ALT, AST)
Frequency: Periodically (e.g., annually or as clinically indicated)
Target: Within normal limits
Action Threshold: Significant elevations (e.g., >3x ULN) may warrant dose reduction or discontinuation, though rare.
Signs and symptoms of bleeding
Frequency: Regularly, especially if co-administered with anticoagulants/antiplatelets
Target: Absence of abnormal bleeding
Action Threshold: Any signs of unusual bleeding (e.g., bruising, petechiae, epistaxis) should prompt investigation.
Symptom Monitoring
- Arthralgia (joint pain)
- Peripheral edema (swelling of extremities)
- Constipation
- Gout
- Atrial fibrillation/flutter (new onset or recurrence)
- Unusual bleeding or bruising
Special Patient Groups
Pregnancy
Limited data on Icosapent Ethyl use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. Consider the benefits of Icosapent Ethyl therapy and the potential risks to the fetus when prescribing to pregnant women. Severe hypertriglyceridemia in pregnancy can be associated with adverse maternal outcomes (e.g., preeclampsia, gestational diabetes, pancreatitis).
Trimester-Specific Risks:
First Trimester:
Risk not well established, but generally low concern for major birth defects based on limited data.
Second Trimester:
Risk not well established.
Third Trimester:
Risk not well established.
Lactation
It is not known 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 Icosapent Ethyl and any potential adverse effects on the breastfed infant from Icosapent Ethyl or from the underlying maternal condition. Consider monitoring the infant for gastrointestinal issues.
Infant Risk:
Low to unknown. Potential for gastrointestinal upset in infant.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients.
Geriatric Use
No overall differences in safety or effectiveness were observed between patients ≥65 years of age and younger patients. No dosage adjustment is needed based on age.
Clinical Information
Clinical Pearls
- Icosapent ethyl is the only omega-3 fatty acid product proven to reduce cardiovascular events in high-risk patients.
- It is crucial to take Icosapent Ethyl with food to ensure proper absorption.
- Patients should be on maximally tolerated statin therapy before initiating Icosapent Ethyl for cardiovascular risk reduction.
- Monitor for signs of bleeding, especially in patients concurrently taking anticoagulants or antiplatelet agents.
- Patients may experience arthralgia (joint pain) as a common side effect.
Alternative Therapies
- Other omega-3 fatty acid products (e.g., Lovaza, Omtryg, Epanova) for hypertriglyceridemia, but not indicated for cardiovascular risk reduction in the same patient population as Icosapent Ethyl.
- Fibrates (e.g., fenofibrate, gemfibrozil)
- Niacin (nicotinic acid)
- Statins (primarily for LDL-C lowering, but also have some TG lowering effects)
- PCSK9 inhibitors (primarily for LDL-C lowering)
Cost & Coverage
Average Cost:
Varies, typically $300-$500+ per 120 capsules (30-day supply)
Insurance Coverage:
Tier 2 or Tier 3 (Specialty drug, may require prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.