FDA approved Kerendia (finerenone) for CKD with Type 2 Diabetes and Heart FailureFDA approved Kerendia for Two Heart and Kidney Conditions

Finerenone is a non-steroidal mineralocorticoid receptor antagonist (nsMRA). The exact mechanism by which it reduces cardiovascular and renal risk is not fully established but is thought to involve blockade of mineralocorticoid receptor overactivation.

Kerendia is indicated to reduce the risk of: sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with CKD associated with T2DM. It is also indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with LVEF 40% or greater.

Measure serum potassium and eGFR before initiation. Do not initiate if serum potassium is greater than 5.0 mEq/L. The recommended starting dose is based on eGFR: 20 mg once daily for eGFR 60 mL/min/1.73 m2 or greater; 10 mg once daily for eGFR 25 to less than 60 mL/min/1.73 m2; initiation is not recommended for eGFR less than 25 mL/min/1.73 m2. Tablets may be taken with or without food. For patients unable to swallow whole tablets, tablets may be crushed and mixed with water or soft foods such as applesauce immediately prior to use.

For CKD associated with T2DM, the target dose is 20 mg once daily. Measure serum potassium 4 weeks after initiation and after dose adjustments, and periodically thereafter. Adjust dose based on serum potassium (Table 2 in label). If serum potassium is greater than 5.5 mEq/L, withhold Kerendia and consider restarting at 10 mg once daily when serum potassium is 5.0 mEq/L or less.

For heart failure with LVEF 40% or greater, the target dose depends on eGFR at initiation: 40 mg once daily if eGFR is 60 mL/min/1.73 m2 or greater; 20 mg once daily if eGFR is 25 to less than 60 mL/min/1.73 m2. Measure serum potassium and eGFR 4 weeks after initiation and after dose adjustments, and periodically thereafter. Adjust dose based on serum potassium, eGFR, and current dose (Table 3 in label). If serum potassium is 5.5 to less than 6.0 mEq/L, withhold or decrease dose; if 6.0 mEq/L or greater, withhold and restart at 10 mg once daily when serum potassium is less than 5.5 mEq/L.

Missed doses: take as soon as possible on the same day; otherwise skip and continue with the next prescribed dose.

FIDELIO-DKD (NCT 02540993) and FIGARO-DKD (NCT 02545049) were randomized, double-blind, placebo-controlled, multicenter studies in adult patients with CKD associated with T2DM. In FIDELIO-DKD, patients needed to have either a urine albumin-to-creatinine ratio (UACR) of 30 to less than 300 mg/g, eGFR 25 to less than 60 mL/min/1.73 m2 and diabetic retinopathy, or a UACR of 300 mg/g or greater and an eGFR of 25 to less than 75 mL/min/1.73 m2. The label text provided is truncated; full trial results and the heart failure trial data are not available in the provided label excerpt.

Warnings and Precautions include hyperkalemia (5.1