Active Ingredient: Finerenone
Finerenone is indicated for the treatment of symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥40% in adults.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A :
Oral, between 10 milligrams finerenone and 20 milligrams finerenone, once daily, over the duration of 4 weeks.
Regimen B :
Oral, between 10 milligrams finerenone and 40 milligrams finerenone, once daily, over the duration of 4 weeks.
The recommended target dose depends on renal function (eGFR) at initiation of finerenone treatment (see table 2):
The maximum recommended dose is 40 mg finerenone once daily.
If serum potassium ≤5.0 mmol/L, finerenone treatment can be initiated. Serum potassium and estimated glomerular filtration rate (eGFR) have to be measured to determine if finerenone treatment can be initiated and to determine the starting dose. For monitoring of serum potassium, see below 'Continuation of treatment'.
The recommended starting dose of finerenone is based on eGFR and is presented in table 1.
Table 1. Initiation of finerenone treatment and recommended dose:
| eGFR (mL/min/1.73 m²) | Starting dose (once daily) |
| ≥60 | 20 mg |
| ≥25 to <60 | 10 mg |
| <25 | Not recommended |
Serum potassium and eGFR have to be remeasured 4 weeks after initiation or re-start of finerenone treatment or change in dose (see table 2 to determine continuation of finerenone treatment and dose adjustment).
Thereafter, serum potassium and eGFR have to be remeasured periodically and as needed based on patient characteristics.
Table 2. Continuation of finerenone treatment and dose adjustment:
| Current finerenone dose (once daily) | ||||
| 10 mg | 20 mg | 40 mg | ||
| Current serum potassium (mmol/L) | ˂5.0 | Increase to 20 mg finerenone once daily if eGFR has not decreased >30% compared to the previous measurement | Increase to 40 mg once daily if eGFR has not decreased >30% compared to the previous measurement Maintain 20 mg once daily if eGFR <60 mL/min/1.73 m² at initiation | Maintain 40 mg once daily Decrease to 20 mg once daily if eGFR has decreased >30% compared to the previous measurement |
| 5.0 to ˂5.5 | Maintain 10 mg once daily | Maintain 20 mg once daily | Maintain 40 mg once daily Decrease to 20 mg once daily if eGFR has decreased >30% compared to the previous measurement | |
| 5.5 to ˂6.0 | Withhold finerenone Re-start at 10 mg once daily when serum potassium ˂5.5 mmol/L. | Decrease to 10 mg once daily | Decrease to 20 mg once daily | |
| ≥6.0 | Withhold finerenone. Re-start at 10 mg once daily when serum potassium ˂5.5 mmol/L or if repeatedly ≥5.5 mmol/L, wait to re-start until ˂5.0 mmol/L. | |||
If eGFR decreases by ≥40% compared to the previous measurement, consider reducing the dose or withholding finerenone. Once eGFR levels have stabilised, according to the individual patient´s characteristics, consider increasing the dose or restarting treatment.
A missed dose should be taken as soon as the patient notices, but only on the same day. The patient should not take 2 doses to make up for a missed dose.
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