What is the recommended dose of finerenone (Minerocorticoid receptor antagonist) for patients with Impaired renal function?

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Finerenone Dosing in Impaired Renal Function

For patients with impaired renal function, start finerenone at 10 mg once daily if eGFR is 25-60 mL/min/1.73 m², and 20 mg once daily if eGFR is >60 mL/min/1.73 m², with uptitration to 20 mg after 1 month if serum potassium remains ≤4.8 mmol/L. 1

Initial Dosing Based on eGFR

The dosing algorithm is straightforward and based on baseline kidney function:

  • eGFR >60 mL/min/1.73 m²: Start at 20 mg once daily 1
  • eGFR 25-60 mL/min/1.73 m²: Start at 10 mg once daily 1
  • eGFR <25 mL/min/1.73 m²: Finerenone can be initiated at eGFR ≥25 mL/min/1.73 m² per trial eligibility, though it may be continued below this threshold if potassium remains acceptable 1

Potassium Requirements for Initiation

Before starting finerenone, verify that serum potassium meets safety thresholds:

  • Trial eligibility criteria: Potassium ≤4.8 mmol/L 1
  • FDA label: Potassium ≤5.0 mmol/L 1

The more conservative 4.8 mmol/L threshold from the FIDELIO-DKD and FIGARO-DKD trials provides the strongest safety evidence. 1

Dose Uptitration Protocol

After 1 month of treatment, consider uptitration from 10 mg to 20 mg daily if: 1

  • Serum potassium remains <4.8 mmol/L 1
  • eGFR is stable 1
  • The medication is well-tolerated 1

This uptitration strategy was used successfully in the pivotal trials, with the goal of achieving the target dose of 20 mg daily for maximal cardiovascular and renal protection. 1

Ongoing Potassium Monitoring

Potassium surveillance is critical to safe finerenone use:

  • Check potassium 4 weeks after any dose change 1
  • Continue regular monitoring throughout treatment 1
  • Continue finerenone if potassium remains ≤5.5 mmol/L 1
  • Withhold finerenone if potassium rises >5.5 mmol/L 1
  • Restart at 10 mg daily when potassium returns to ≤5.0 mmol/L 1

Pharmacokinetic Considerations in Renal Impairment

Exposure to finerenone increases with worsening renal function, though this is already accounted for in the dosing algorithm:

  • Mild renal impairment (CrCl 50-80 mL/min): No significant change in exposure 2
  • Moderate renal impairment (CrCl 30-<50 mL/min): 57% increase in unbound finerenone exposure 2
  • Severe renal impairment (CrCl <30 mL/min): 47% increase in unbound finerenone exposure 2

The lower starting dose of 10 mg in patients with eGFR 25-60 mL/min/1.73 m² compensates for this increased exposure and maintains safety. 2

Critical Safety Considerations

Hyperkalemia is the primary safety concern, but discontinuation rates remain low:

  • In FIDELIO-DKD, hyperkalemia led to discontinuation in only 2.3% of finerenone patients versus 0.9% of placebo patients 1
  • In FIGARO-DKD, only 1.2% discontinued due to hyperkalemia 1, 3
  • No deaths related to hyperkalemia occurred in either trial 1, 3

The dose titration protocol based on potassium monitoring effectively manages this risk. 4

Patient Eligibility Beyond eGFR

Finerenone should only be initiated in patients who meet these additional criteria:

  • Type 2 diabetes with chronic kidney disease 1
  • Albuminuria (UACR ≥30 mg/g) despite standard care 1
  • Already on maximum tolerated dose of RAS inhibitor (ACE inhibitor or ARB) 1
  • Normal serum potassium as defined above 1

Continuation Below eGFR 25 mL/min/1.73 m²

While initiation requires eGFR ≥25 mL/min/1.73 m², finerenone can be continued if eGFR declines below this threshold during treatment, provided potassium remains acceptable and the drug is tolerated. 1 This allows for ongoing cardiorenal protection in patients with progressive disease.

Combination with SGLT2 Inhibitors

Recent evidence supports combining finerenone with SGLT2 inhibitors for additive benefit:

  • The CONFIDENCE trial demonstrated that combination therapy with finerenone plus empagliflozin reduced albuminuria 29% more than finerenone alone and 32% more than empagliflozin alone 5
  • No unexpected adverse events occurred with combination therapy 5
  • This supports the ADA/KDIGO recommendation to layer finerenone onto existing SGLT2 inhibitor therapy 1, 6

References

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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