VAZKEPA

What it is

VAZKEPA contains icosapent ethyl, with each soft capsule containing 998 mg of icosapent ethyl. Icosapent ethyl is a stable ethyl ester of the omega-3 fatty acid, eicosapentaenoic acid (EPA).

Approved indications —

Adults treated with statin with established cardiovascular disease, at high cardiovascular risk with elevated triglycerides (≥ 1.7 mmol/L), to reduce the risk of cardiovascular events — Adults treated with statin with diabetes and at least one other cardiovascular risk factor, at high cardiovascular risk with elevated triglycerides (≥ 1.7 mmol/L), to reduce the risk of cardiovascular events

Dosing overview

The recommended daily oral dose is 4 capsules taken as two 998 mg capsules twice daily. VAZKEPA should be taken with or following a meal. Patients should be advised to swallow the capsules whole and not to break, crush, dissolve, or chew them. No dose reduction is recommended for renal impairment, hepatic impairment, or based on age.

Key safety warnings

VAZKEPA was associated with an increased risk of atrial fibrillation or flutter requiring hospitalisation in a double-blind placebo-controlled trial, with greater incidence in patients with a previous history of atrial fibrillation or flutter. Patients, particularly those with relevant medical history, should be monitored for clinical evidence of atrial fibrillation or atrial flutter, and electrocardiographic evaluation should be performed when clinically indicated. Treatment with VAZKEPA has been associated with an increased incidence of bleeding, and patients taking it along with antithrombotic agents may be at increased risk of bleeding and should be monitored periodically. VAZKEPA is obtained from the oil of fish, and it is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction; it should be used with caution in patients with known hypersensitivity to fish and/or shellfish.

Contraindications

VAZKEPA is contraindicated in patients with hypersensitivity to the active substance, soya, or to any of the excipients. Patients with hereditary fructose intolerance should not take this medicine. Patients who are allergic to soya or peanut should not use this medicine.

PBS listing

VAZKEPA 998 mg capsule is listed on the PBS with streamlined restriction at an ex-manufacturer price of A$129.00.

Regulatory history

VAZKEPA icosapent ethyl 998 mg was first listed on the ARTG on 2022-11-08. In November 2023, the PBAC did not recommend VAZKEPA for treatment of atherosclerotic cardiovascular disease with elevated triglycerides, citing low clinical need, uncertain benefit, and high and uncertain utilisation and financial impact, and nominated an Early Re-Entry resubmission pathway. In March 2024, the PBAC recommended VAZKEPA for atherosclerotic cardiovascular disease with elevated triglycerides.