OTHER INDICATIONS — Finerenone is also FDA-approved to reduce the risk of kidney disease progression and cardiovascular events in adults with CKD associated with type 2 diabetes and to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), and urgent HF visits in adults with HF with a left ventricular ejection fraction (LVEF) ≥40%.1,2

MECHANISM OF ACTION — CKD and cardiovascular disease are common complications of type 1 diabetes. Finerenone inhibits aldosterone at the mineralocorticoid receptor, preventing receptor overactivation and decreasing the fibrosis that leads to kidney dysfunction and cardiovascular disease.

A CLINICAL STUDY — FDA approval of finerenone for the new indication was based on the results of a double-blind trial (FINE-ONE) in 242 adults with type 1 diabetes, CKD, and albuminuria. Patients were randomized to receive finerenone 10 or 20 mg or placebo, each in addition to standard treatment (an angiotensin-converting enzyme [ACE] inhibitor or angiotensin receptor blocker [ARB]). Patients with symptomatic HF with a reduced ejection fraction and those who had received a sodium-glucose cotransporter 2 (SGLT2) inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonist in the prior 8 weeks were excluded. The reduction from baseline in UACR over 6 months, the primary endpoint, was significantly greater with finerenone than with placebo (34% vs 12%). Longer studies are needed to evaluate the effect of finerenone on eGFR and clinical kidney outcomes.3

ADVERSE EFFECTS — The most common adverse effect of finerenone in the FINE-ONE trial was hyperkalemia.

DRUG INTERACTIONS — Concurrent use of finerenone and other drugs that increase serum potassium levels increases the risk of hyperkalemia. Finerenone is a substrate of CYP3A4; use with CYP3A4 inducers or inhibitors could alter serum concentrations of finerenone. Concurrent use of finerenone and strong CYP3A4 inhibitors or strong or moderate CYP3A4 inducers should be avoided.4

PREGNANCY AND LACTATION — Finerenone has not been studied in pregnant or lactating women. Administration of the drug to pregnant animals was associated with fetal toxicity, skeletal and visceral malformations, and embryo-fetal mortality. Breastfeeding should be avoided during treatment with finerenone.

DOSAGE, ADMINISTRATION, AND COST — The recommended starting dosage of finerenone is 10 mg (eGFR 25-<60 mL/min/1.73 m²) or 20 mg (eGFR ≥60 mL/min/1.73 m²) once daily; the target dose is 20 mg once daily. Finerenone should not be used in patients with an eGFR <25 mL/min/1.73 m² or in those with severe hepatic impairment (Child-Pugh C). Serum potassium levels should be measured before and 4 weeks after starting the drug. Finerenone should not be started in patients with a serum potassium level >5.0 mEq/L. The label contains dosage adjustments that should be made based on serum potassium levels. A 30-day supply of Kerendia 20-mg tablets costs $715.50.5

CONCLUSION — In adults with chronic kidney disease associated with type 1 diabetes, addition of the nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia) to standard treatment reduces the urinary albumin-tocreatinine ratio (UACR). Longer studies are needed to evaluate the effect of the drug on clinical kidney outcomes.