INPLER

What it is

INPLER contains eplerenone . Eplerenone is supplied as film-coated tablets containing 25 or 50 mg eplerenone .

Approved indications

INPLER is indicated 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 . INPLER is indicated 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, the recommended dose of INPLER is 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 (CKD stages 1, 2 and partly 3), 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 the serum potassium levels . Serum potassium should be measured before initiating INPLER therapy, within the first week and at 1 month after the start of treatment or dosage adjustment. Serum potassium should be assessed periodically thereafter, and the dose of INPLER adjusted based on the serum potassium level .

PBS listing

INPLER 50 mg and 25 mg tablets are listed on the PBS with streamlined restriction at an ex-manufacturer price of A$37.79 each .

Regulatory history

INPLER eplerenone 50 mg and 25 mg tablet blister packs were first listed on the ARTG on 21 October 2015 .