finerenone

Common name: finerenone

Trade name: Kerendia

All names: finerenone, finerenone, Kerendia

Indications:

< Kerendia is a nonsteroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained eGFR decline, end-stage renal disease, cardiovascular death, nonfatal myocardial infarction, and heart failure hospitalization in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

Dosage:

Based on estimated glomerular filtration rate (eGFR) and serum potassium threshold, the recommended starting dose is 10 mg or 20 mg, taken orally once daily.

Based on eGFR and serum potassium threshold, increase the dose to the target dose of 20 mg once daily after 4 weeks.

Tablets can be taken with or without food.

Specifications:

30 tablets/bottle: 10mg or 20mg dosage form;

90 tablets/bottle: 10mg or 20mg dosage form.

Adverse reactions:

Adverse reactions that occurred in ≥ 1% of patients in the Kerendia group (occurring more frequently than in the placebo group) were hyperkalemia, hypotension, and hyponatremia.

Contraindications:

Concomitant use of strong CYP3A4 inhibitors.

Patients with adrenal insufficiency.

Precautions:

Hyperkalemia: Patients with reduced renal function and high baseline potassium levels are at increased risk. Monitor serum potassium levels and adjust dosage as needed.

Grapefruit or grapefruit juice: Avoid use together.

Moderate or weak CYP3A4 inhibitors: Monitor serum potassium during drug initiation or dose adjustment of Kerendia or moderate or weak CYP3A4 inhibitors and adjust Kerendia dose appropriately.

Strong or moderate CYP3A4 inducers: avoid concurrent use.

Breastfeeding: Breastfeeding is not recommended.

Storage:

Storage temperature: 20°C to 25°C (68°F to 77°F); allowed to fluctuate within the range of 15°C to 30°C (59°F to 86°F).

Mechanism of Action:

Kerendia (finerenone) is a potentially first-in-class, nonsteroidal, selective mineralocorticoid receptor antagonist (MRA) that reduces the harmful effects of mineralocorticoid receptor (MR) overactivation.

Safety and Efficacy:

The FIDELIO-DKD study was conducted in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD) to evaluate the efficacy and safety of finerenone versus placebo. Patients in both groups received standard care, including hypoglycemic therapy and maximal tolerated doses of renin-angiotensin system (RAS) blocking therapy, such as angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB).

The results showed that the study met the primary endpoint: when combined with standard care, finerenone significantly reduced the risk of the composite primary endpoint of CKD progression, renal failure, and renal death compared with placebo. Specifically, over a median follow-up of 2.6 years, finerenone significantly reduced the composite risk of first onset of renal failure, sustained reduction in estimated glomerular filtration rate (eGFR) by ≥40% from baseline for at least 4 weeks, and renal death by 18% compared with placebo (HR=0.82; 95% CI: 0.73-0.93; p=0.0014). At 36 months, the number needed to treat to prevent one primary composite endpoint event was 29 (95% CI: 16-166).