Dosing & Uses
Dosage Forms & Strengths
capsule
- 0.5g
- 1g
Severe Hypertriglyceridemia
Indications
- Indicated as an adjunct to diet to reduce high triglyceride (TG) levels (ie, ≥500 mg/dL)
-
Cardiovascular risk reduction
- Indicated as an adjunct to maximally tolerated statin therapy to reduce risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adults with elevated TG levels (≥150 mg/dL), AND
- Established cardiovascular disease, OR
- Diabetes mellitus and 2 or more additional risk factors for CV disease
Dose
- 2g PO q12hr with food
Dosing Considerations
Limitation of use
- Effect on risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined
Before initiating
- Assess lipid levels; identify other causes (eg, diabetes mellitus, hypothyroidism, medications) of high triglyceride levels and manage as appropriate
- Patients should engage in appropriate nutritional intake and physical activity before and during icosapent treatment
- Measure ALT/AST periodically in patients with hepatic impairment
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (25)
- abciximab
icosapent, abciximab. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- anagrelide
icosapent, anagrelide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- antithrombin alfa
icosapent, antithrombin alfa. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- antithrombin III
icosapent, antithrombin III. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- argatroban
icosapent, argatroban. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- aspirin
icosapent, aspirin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- aspirin/citric acid/sodium bicarbonate
icosapent, aspirin/citric acid/sodium bicarbonate. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- bivalirudin
icosapent, bivalirudin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- cilostazol
icosapent, cilostazol. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- clopidogrel
icosapent, clopidogrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- dabigatran
icosapent, dabigatran. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- dalteparin
icosapent, dalteparin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- desirudin
icosapent, desirudin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- dipyridamole
icosapent, dipyridamole. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- enoxaparin
icosapent, enoxaparin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- eptifibatide
icosapent, eptifibatide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- fondaparinux
icosapent, fondaparinux. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- heparin
icosapent, heparin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- prasugrel
icosapent, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- protein C concentrate
icosapent, protein C concentrate. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- rivaroxaban
icosapent, rivaroxaban. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- ticagrelor
icosapent, ticagrelor. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- ticlopidine
icosapent, ticlopidine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- tirofiban
icosapent, tirofiban. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.
- warfarin
icosapent increases effects of warfarin by anticoagulation. Use Caution/Monitor.
Minor (0)
Adverse Effects
>10%
Bleeding event (12%)
1-10%
Musculoskeletal pain (≥3%)
Peripheral edema (≥3%)
Constipation (≥3%)
Gout (≥3%)
Atrial fibrillation or flutter (3%)
Serious bleeding event (3%)
Postmarketing Reports
Diarrhea
Blood TG increased
Abdominal discomfort
Pain in extremities
Warnings
Contraindications
Hypersensitivity to drug or any of its components
Cautions
Associated with increased risk of atrial fibrillation or atrial flutter requiring hospitalization compared with placebo (3% vs 2%)
Contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fish; unknown whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction
Use associated with increased risk of bleeding; incidence is greater if taking concomitant antithrombotic medications (eg, aspirin, clopidogrel, or warfarin)
Drug interaction overview
- Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time; bleeding time reported in those studies has not exceeded normal limits and did not produce clinically significant bleeding episodes
- Monitor patients receiving icosapent with anticoagulants and/or antiplatelet agents for bleeding
Pregnancy & Lactation
Pregnancy
Available data from published case reports and the pharmacovigilance database on the use in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes
Animal studies
- In animal reproduction studies in pregnant rats, nondose-related imbalances for some minor developmental findings were observed with oral administration of icosapent ethyl during organogenesis at exposures that were equivalent to the clinical exposure at the human dose of 4 g/day, based on body surface area comparisons
Lactation
Published studies have detected omega-3 fatty acids, including EPA, in human milk
Lactating women receiving oral omega-3 fatty acids for supplementation have resulted in higher levels of omega-3 fatty acids in human milk
There are no data on the effects of omega-3 fatty acid ethyl esters on the breastfed infant or on milk production
Consider developmental and health benefits of breastfeeding along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Ethyl ester of eicosapentaenoic acid (EPA); EPA has been shown to reduce hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion; enhances triglyceride clearance from circulating VLDL particle; may also increase beta-oxidation, inhibits acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT), decrease lipogenesis in liver, and increase plasma lipoprotein lipase activity
The mechanisms of action contributing to reduction of cardiovascular events are not completely understood but are likely multifactorial; increased EPA lipid composition from carotid plaque specimens and increased circulating EPA/arachidonic acid ratio have been observed following EPA treatment; EPA inhibits platelet aggregation under some ex vivo conditions
Absorption
De-esterified during absorption to active EPA that is absorbed in small intestine
Peak Plasma Time: 5 hr
Distribution
Protein Bound: >99% of unesterified EPA
Vd: 88 L
Metabolism
Mainly metabolized by the liver via beta-oxidation similar to dietary fatty acids; minor CYP450 mediated metabolism
Elimination
Half-life: 89 hr
Does not undergo renal excretion
Total plasma clearance: 684 mL/hr
Administration
Oral Administration
Swallow capsule whole; do not break open, dissolve, crush, or chew
Storage
Store at controlled room temperature of 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| icosapent ethyl oral - | 1 gram capsule |  | |
| icosapent ethyl oral - | 1 gram capsule |  | |
| icosapent ethyl oral - | 1 gram capsule |  | |
| Vascepa oral - | 0.5 gram capsule |  | |
| Vascepa oral - | 1 gram capsule |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
icosapent ethyl oral
ICOSAPENT ETHYL - ORAL
(eye-KOE-sa-pent ETH-il)
COMMON BRAND NAME(S): Vascepa
USES: Icosapent ethyl is used along with certain other cholesterol medications ("statins" such as atorvastatin, simvastatin) to reduce the risk of heart attack, stroke, and certain types of heart problems that require treatment in a hospital. It is also used along with a proper diet to help lower fats (triglycerides) in the blood. Icosapent ethyl is a type of omega-3 fatty acid, a fat found in fish oil. It is thought to work by decreasing the amount of triglycerides made by the body.In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking icosapent ethyl and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with food as directed by your doctor, usually twice a day. Swallow the capsules whole. Do not crush, chew, open, or dissolve the capsules.Do not substitute other omega-3 fatty acids or fish oil products (such as nonprescription products, vitamins, supplements) for this product without talking with your doctor first. They may not contain the same amount and type of fatty acids.Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Keep taking this medication even if you feel well.It is very important to continue to follow your doctor's advice about diet and exercise.
SIDE EFFECTS: Joint/muscle pain or constipation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: fast/irregular heartbeat, easy bruising/bleeding, swelling ankles/feet/hands.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking icosapent ethyl, tell your doctor or pharmacist if you are allergic to it; or to fish or shellfish products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, irregular heartbeat (such as atrial fibrillation).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as cholesterol/triglyceride levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2021. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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