Icosapent Ethyl Application Scope

Adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (≥ 500 mg/dL).
In adults with elevated TG (≥150 mg/dL) and established cardiovascular disease, or diabetes plus two or more additional risk factors for cardiovascular disease, used in addition to statin therapy to reduce the risk of major adverse cardiovascular events (MI, stroke, coronary revascularization, cardiovascular death).

Icosapent Ethyl Characteristics

Ingredients:
- Active: Icosapent ethyl (an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid, EPA).
- Inactive (capsule): bloom gelatin, glycerin, α-tocopherol, medium chain triglycerides, lecithin; imprint components include titanium dioxide, propylene glycol, hypromellose.
Properties: Icosapent ethyl is an ethyl ester prodrug of EPA. It lowers triglycerides by reducing hepatic VLDL-TG synthesis and enhancing TG clearance; the precise mechanism(s) for cardiovascular risk reduction remain incompletely defined. Classified as an omega-3-derived antilipemic agent.
Packaging Specification: Liquid-filled soft gelatin capsules: 0.5 g (500 mg) and 1 g (1000 mg) strengths (amber, softgel capsules). Each capsule labeled with appropriate imprint.
Storage: Store in original package to protect from moisture. Store at controlled room temperature—below 30°C (specific local labelling: e.g., EMA: below 30°C; FDA label guidance included in product insert). Protect from moisture.
Expiry Date: See carton/vial for expiration date (follow printed expiry on packaging).
Executive Standard: Product labeling and quality controlled under relevant regulatory standards (e.g., FDA approved product monograph / EMA product information for Vazkepa).
Approval Number: FDA NDA for VASCEPA: NDA 202057 (see FDA references). (Regional approvals may have different identifiers; EU product marketed as Vazkepa.)
Date of Revision: Refer to the latest prescribing information / product label for the most recent revision date (label PDF usually lists revision). Example label updates available 2019 / 2020 on FDA site.
Manufacturer: Amarin Corporation plc (marketed in the U.S. as VASCEPA®). (In EU marketed as Vazkepa; regional distributors may vary.)

Guidelines for the Use of Icosapent Ethyl

Dosage and Administration:
- Recommended Dose: 4 grams per day total, typically given as 2 g (two 1-g capsules) twice daily or equivalent (for severe hypertriglyceridemia and for CV risk reduction as per labeled indication). Confirm exact capsule count/strength per local label.
- Administration: Oral capsules with food (label guidance: administer with food to improve absorption according to local prescribing information; confirm with local product insert).
- Missed Dose: If a dose is missed, take it as soon as remembered. Do not double doses to make up for missed doses — follow the local prescribing information for specific instructions. (Patient info and label guidance recommend not doubling doses.)
Adverse Reactions:
- Common Adverse Reactions: Arthralgia, peripheral edema, constipation, and other GI symptoms; typical adverse events reported in trials included musculoskeletal complaints and GI effects.
- Serious Adverse Reactions: Atrial fibrillation/flutter (reported increased incidence in some trials), bleeding events (see precautions with antiplatelet/anticoagulant therapy), hypersensitivity reactions (fish- or shellfish-derived ingredient caution). Monitor for serious bleeding.
Contraindications: Known hypersensitivity to icosapent ethyl or any component of the formulation. Use caution in patients with known fish or shellfish allergy (label warns to use with caution). There is no absolute blanket contraindication beyond hypersensitivity listed in standard labels.
Precautions:
- Bleeding risk: Use caution with concomitant antiplatelet and anticoagulant therapy — may increase bleeding risk. Monitor as clinically indicated.
- Hepatic impairment: Monitor liver enzymes; use caution in hepatic impairment.
- Atrial fibrillation / cardiac events: Monitor for arrhythmias in patients at risk.

Icosapent Ethyl Interactions

Anticoagulants / Antiplatelet agents: Concomitant use may increase risk of bleeding — monitor.
No major CYP drug-drug interactions typical of small-molecule CYP substrates are prominent for icosapent ethyl; consult local label for full interaction table.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.