APO-EPLERENONE

What it is

APO-EPLERENONE is eplerenone supplied as film-coated tablets containing 25 or 50 mg of the active ingredient.

Approved indications

— To reduce the risk of cardiovascular death in combination with standard therapy in patients who have evidence of heart failure and left ventricular impairment within 3–14 days of an acute myocardial infarction. — To reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA Class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ≤30% or LVEF ≤35% in addition to QRS duration of >130 msec), in addition to standard optimal therapy.

Dosing overview

For post-myocardial infarction heart failure, APO-EPLERENONE is usually administered in combination with standard therapies with a recommended dose of 50 mg once daily. Treatment should be initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks as tolerated by the patient. For patients with NYHA Class II (chronic) heart failure and eGFR ≥50 mL/min/1.73 m², treatment should be initiated at a dose of 25 mg once daily and titrated to the target dose of 50 mg once daily preferably within 4 weeks, taking into account serum potassium levels. Serum potassium should be measured before initiating APO-EPLERENONE therapy, within the first week and at 1 month after the start of treatment or dosage adjustment, and assessed periodically thereafter with dose adjustments based on serum potassium level.

Regulatory history

APO-EPLERENONE 25 mg and 50 mg tablet formulations were first listed on the Australian Register of Therapeutic Goods on 8 August 2018.