KERENDIA

What it is

Kerendia contains finerenone 10 mg, 20 mg or 40 mg . Finerenone is a nonsteroidal antagonist of the mineralocorticoid receptor that potently attenuates inflammation and fibrosis mediated by mineralocorticoid receptor overactivation . This medicinal product is subject to additional monitoring in Australia .

Approved indications

— Chronic kidney disease: to delay progressive decline of kidney function and to reduce the risk of cardiovascular mortality and morbidity in adults with chronic kidney disease (with albuminuria) associated with Type 2 diabetes, in addition to standard of care . — Heart failure: treatment of symptomatic heart failure with left ventricular ejection fraction (LVEF) of ≥40% in adults .

Dosing overview

The starting dose of Kerendia is 20 mg once daily if eGFR ≥60 mL/min/1.73m² or 10 mg once daily if eGFR ≥25 to <60 mL/min/1.73m² . Initiation of Kerendia treatment is not recommended in patients with eGFR <25 mL/min/1.73m² as clinical experience is limited . Tablets may be taken with a glass of water and with or without food .

Key safety warnings

Hyperkalaemia has been observed in patients treated with Kerendia. Some patients are at a higher risk to develop hyperkalaemia. Risk factors include low eGFR, higher serum potassium and previous episodes of hyperkalaemia . Initiation of Kerendia treatment is recommended when serum potassium ≤4.8 mmol/L for chronic kidney disease. If serum potassium >5.0 mmol/L, initiation of Kerendia treatment is not recommended . For heart failure, initiation of Kerendia treatment is recommended when serum potassium ≤5.0 mmol/L . Kerendia may cause an initial decrease in eGFR due to hemodynamic changes related to the mechanism of action of the drug. This decrease is typically observed within weeks of initiating treatment and then stabilises and is reversible after treatment discontinuation . In patients with heart failure, a greater risk of events related to worsening of renal function was observed in patients receiving Kerendia treatment compared to placebo. Most of these events were mild to moderate in severity. Rarely, severe events associated with worsening renal function, including events requiring hospitalisation, have been observed .

Contraindications

Kerendia is contraindicated in patients taking concomitant medications that are strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin and nefazodone) and in patients with adrenal insufficiency .

PBS listing

The 10 mg and 20 mg tablet strengths are listed on the PBS with streamlined restriction and an ex-manufacturer price of A$66.08 each .

Regulatory history

Kerendia 10 mg and 20 mg tablets were first registered on the ARTG on 25 November 2021 . In July 2022, the PBAC recommended against listing for diabetic kidney disease. In March 2023, the PBAC recommended listing for chronic kidney disease in Type 2 diabetes . The 40 mg tablet strength was registered on the ARTG on 5 March 2026 .