What are the side effects of finerenone?

Side Effects of Finerenone

The primary side effect of finerenone is hyperkalemia (elevated potassium levels), which occurs in approximately 10.8% of patients compared to 5.3% with placebo, though only 1.2% of patients discontinue treatment due to this side effect. 1

Common Side Effects

• Hyperkalemia: The most significant side effect, with an incidence of 10.8% versus 5.3% in placebo groups 1

  • Severe hyperkalemia requiring drug discontinuation is relatively low at 1.7% versus 0.6% with placebo 2
  • Potassium levels should be <4.8 mmol/L before initiation of therapy 1

• Hypotension: Finerenone causes modest blood pressure lowering effects of 2-3 mmHg systolic 3

  • Significantly increased risk of hypotension compared to placebo (RR = 1.49,95% CI 1.31-1.68) 4

Monitoring and Management

• Potassium monitoring:

  • Serum potassium should be <4.8 mmol/L before initiation 2
  • Regular monitoring is required during treatment 2
  • If potassium increases to >5.5 mmol/L, finerenone should be withheld and can be restarted at 10 mg daily when potassium is ≤5.0 mmol/L 2

• Dosing considerations:

  • Initial dose is 10 mg once daily for patients with eGFR 25-60 mL/min/1.73m² 2
  • Initial dose is 20 mg once daily for patients with eGFR >60 mL/min/1.73m² 2
  • Dose can be uptitrated to 20 mg daily if serum potassium remains <4.8 mmol/L after 4 weeks 2

Advantages Compared to Steroidal MRAs

• No hormonal side effects: Unlike spironolactone (a steroidal MRA), finerenone does not cause gynecomastia or sexual dysfunction 3, 5

• No effect on glycemic control: Finerenone has no effect on HbA1c or body weight 5

• Better safety profile: Compared to eplerenone, finerenone is associated with lower risk of treatment-emergent adverse events (RR = 0.93,95% CI: 0.89-0.98) and serious adverse events (RR = 0.74,95% CI: 0.66-0.84) 4

• Compared to spironolactone: Finerenone may have a lower risk of treatment-emergent adverse events (RR = 0.64,95% CI 0.56-0.74), treatment discontinuation (RR = 0.37,95% CI 0.25-0.54), and hyperkalemia (RR = 0.41,95% CI 0.21-0.79) 4

Clinical Considerations

• Risk factors for hyperkalemia:

  • Decreased renal function increases the risk of hyperkalemia 6
  • Concomitant use of RAS inhibitors (ACE inhibitors or ARBs) may increase hyperkalemia risk 6

• Prevention of hyperkalemia:

  • Starting treatment early when eGFR is maintained may reduce side effects 6
  • Potassium-binding agents may be considered to prevent hyperkalemia in high-risk patients 6

• Contraindications:

  • Serum potassium >4.8 mmol/L before initiation 1
  • eGFR <25 mL/min/1.73m² 2

Special Populations

• Heart failure patients: Finerenone (10-25 mg) showed a similar safety profile to placebo, with no significant differences in treatment-emergent adverse events, serious adverse events, or treatment discontinuation 4

• Early CKD stages: Starting finerenone treatment at an early stage of CKD may result in stronger clinical effects and fewer side effects 6