Finerenone

Kerendia is indicated to: reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adults with chronic kidney disease (CKD) associated with Type 2 diabetes mellitus (T2DM). reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce the risk of sustained eGFR decline and end-stage kidney disease in adults with CKD associated with Type 1 diabetes mellitus (T1DM). reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%.

Finerenone is a nonsteroidal, selective antagonist of the mineralocorticoid receptor (MR), which is activated by aldosterone and cortisol and regulates gene transcription. Finerenone blocks MR mediated sodium reabsorption and MR overactivation in both epithelial (e.g., kidney) and nonepithelial (e.g., heart, and blood vessels) tissues. MR overactivation is thought to contribute to fibrosis and inflammation. Finerenone has a high potency and selectivity for the MR and has no relevant affinity for androgen, progesterone, estrogen, and glucocorticoid receptors.

The recommended starting dosage is 10 mg or 20 mg orally once daily based on eGFR and serum potassium thresholds. Increase dosage after 4 weeks to the target dose of 20 mg once daily for CKD associated with T2DM or T1DM based on eGFR and serum potassium thresholds. Increase dosage after 4 weeks to the target dose of 20 mg or 40 mg once daily for heart failure with LVEF ≥ 40% based on eGFR and serum potassium thresholds. Tablets may be taken with or without food.

Kerendia is contraindicated in patients: Who are hypersensitive to any component of this product. Who are receiving concomitant treatment with strong CYP3A4 inhibitors. With adrenal insufficiency. Hypersensitivity to any component of this product. Concomitant use with strong CYP3A4 inhibitors. Patients with adrenal insufficiency.

Hyperkalemia. Patients with decreased kidney function and higher baseline potassium levels are at increased risk. Monitor serum potassium levels and adjust dose as needed. Worsening of Renal Function in Patients with Heart Failure. Measure eGFR and adjust dose as needed.

The following serious adverse reactions are discussed elsewhere in the labeling: Hyperkalemia Adverse reactions occurring in ≥ 1% of patients on Kerendia and more frequently than placebo are hyperkalemia, hypotension, and hyponatremia.

Strong CYP3A4 Inhibitors: Use is contraindicated. Grapefruit or grapefruit juice: Avoid concomitant use. Moderate or weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either Kerendia or the moderate or weak CYP3A4 inhibitor, and adjust Kerendia dosage as appropriate. Strong or moderate CYP3A4 Inducers: Avoid concomitant use. Sensitive CYP2C8 substrates at Kerendia 40 mg: Monitor more frequently for adverse reactions.

Store at 20°C to 25°C (68°F to 77°F), excursions are permitted from 15°C to 30°C (59°F to 86°F ).