Icosapent Ethyl 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 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 levels of triglycerides (a type of fat) in the blood. It is also used to reduce the risk of heart attack, stroke, and certain other heart problems in adults with existing heart disease or diabetes and at least two other risk factors, 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.
It's essential to continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. This will help ensure that you receive the full benefits of the treatment.
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. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it 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 any 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.
It's essential to continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. This will help ensure that you receive the full benefits of the treatment.
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. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it 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 any 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.
- Avoid excessive alcohol consumption.
- Do not stop taking other prescribed medications (e.g., statins) unless directed by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
4 grams daily, taken as two 1-gram capsules twice daily with food
Dose Range:
4 - 4 mg
Condition-Specific Dosing:
severeHypertriglyceridemia:
4 grams daily, taken as two 1-gram capsules twice daily with food
cardiovascularRiskReduction:
4 grams daily, taken as two 1-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
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
Pharmacology
Mechanism of Action
The precise mechanism of action by which icosapent ethyl reduces triglyceride (TG) levels and cardiovascular risk is not completely understood. It is believed to involve multiple mechanisms, including inhibition of diacylglycerol acyltransferase, increased hepatic beta-oxidation, reduced hepatic very low-density lipoprotein triglyceride (VLDL-TG) synthesis and secretion, and increased plasma TG clearance. It may also have anti-inflammatory and anti-atherosclerotic effects.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified, but well absorbed
Tmax:
Approximately 5-9 hours (for total eicosapentaenoic acid [EPA])
FoodEffect:
Absorption is increased when taken with a high-fat meal.
Distribution:
Vd:
Approximately 88 L
ProteinBinding:
>99% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 89 hours (for total EPA)
Clearance:
Not precisely quantified, but eliminated via metabolic pathways
ExcretionRoute:
Primarily via respiration as CO2 and feces; minimal renal excretion
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Triglyceride lowering effects typically observed within weeks
PeakEffect:
Maximal triglyceride lowering observed after several weeks of consistent dosing
DurationOfAction:
Effects persist as long as therapy 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 side effect:
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. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
Muscle pain
* Constipation
Note: This list is not exhaustive, and you may experience other 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.
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 side effect:
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. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
Muscle pain
* Constipation
Note: This list is not exhaustive, and you may experience other 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.
Seek Immediate Medical Attention If You Experience:
- Unusual bleeding or bruising (e.g., nosebleeds, gum bleeding, blood in urine or stool, petechiae)
- Signs of atrial fibrillation or flutter (e.g., feeling your heart race or beat irregularly, chest pain, shortness of breath, dizziness, fatigue)
- Severe or persistent diarrhea, nausea, or abdominal pain
- Signs of an allergic reaction (e.g., rash, itching, swelling of the face/tongue/throat, 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, 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 health problems you have, as they may affect the safety and efficacy of the medication.
To guarantee your safety, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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 health problems you have, as they may affect the safety and efficacy of the medication.
To guarantee your safety, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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 immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment should be symptomatic and supportive.
Drug Interactions
Monitoring
Baseline Monitoring
Fasting Lipid Panel (Triglycerides, LDL-C, HDL-C, Non-HDL-C)
Rationale: To establish baseline lipid levels and assess eligibility for therapy.
Timing: Prior to initiation of therapy
Liver Function Tests (ALT, AST)
Rationale: To establish baseline liver enzyme levels, as elevations have been reported.
Timing: Prior to initiation of therapy
Routine Monitoring
Fasting Lipid Panel (Triglycerides, LDL-C, HDL-C, Non-HDL-C)
Frequency: Periodically (e.g., 3-6 months after initiation, then annually or as clinically indicated)
Target: Triglycerides <150 mg/dL (for hypertriglyceridemia); LDL-C and Non-HDL-C according to guideline-recommended targets for cardiovascular risk reduction.
Action Threshold: Persistent elevation of triglycerides despite therapy, or inadequate response to therapy.
Liver Function Tests (ALT, AST)
Frequency: Periodically (e.g., annually or as clinically indicated), especially if baseline levels were elevated.
Target: Within normal limits
Action Threshold: Clinically significant or persistent elevations (e.g., >3x ULN); consider dose reduction or discontinuation.
Signs/Symptoms of Bleeding
Frequency: Ongoing patient education and monitoring
Target: Absence of abnormal bleeding
Action Threshold: Any unusual bruising, petechiae, epistaxis, or other signs of bleeding; evaluate coagulation status if clinically indicated.
Signs/Symptoms of Atrial Fibrillation/Flutter
Frequency: Ongoing patient education and monitoring
Target: Absence of new-onset or recurrent atrial fibrillation/flutter
Action Threshold: New-onset or recurrent palpitations, chest pain, shortness of breath, or fatigue; perform ECG and manage appropriately.
Symptom Monitoring
- Unusual bleeding or bruising (e.g., nosebleeds, gum bleeding, petechiae)
- Signs of atrial fibrillation or flutter (e.g., palpitations, rapid or irregular heartbeat, chest pain, 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. Animal studies have shown no evidence of developmental toxicity. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies suggest no increased risk of major birth defects.
Second Trimester:
Limited human data; animal studies suggest no increased risk of major birth defects.
Third Trimester:
Limited human data; animal studies suggest no increased risk of major birth defects.
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. Caution should be exercised when icosapent ethyl is administered to a nursing woman.
Infant Risk:
Risk is unknown. Potential for gastrointestinal upset or other effects in the infant. Monitor breastfed infants for adverse reactions.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No specific dose adjustment is required based on age, but monitor for adverse effects.
Clinical Information
Clinical Pearls
- Icosapent ethyl must be taken with food to ensure proper absorption.
- It is not a substitute for statin therapy for dyslipidemia; it is typically used as an adjunct to maximally tolerated statin therapy.
- Patients should be advised about the potential for increased bleeding risk, especially if they are also taking anticoagulants or antiplatelet agents.
- There is an increased risk of atrial fibrillation or atrial flutter in patients treated with icosapent ethyl, particularly in those with a history of these conditions.
- Capsules should be swallowed whole; do not break, crush, dissolve, or chew.
Alternative Therapies
- Statins (e.g., atorvastatin, rosuvastatin, simvastatin)
- Fibrates (e.g., fenofibrate, gemfibrozil)
- Niacin (nicotinic acid)
- Other omega-3 fatty acid products (e.g., omega-3-acid ethyl esters [Lovaza])
- PCSK9 inhibitors (e.g., evolocumab, alirocumab)
- Bempedoic acid
- Ezetimibe
Cost & Coverage
Average Cost:
Varies widely, typically several hundred dollars per 120 capsules (1 month supply)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand/generic)
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.