Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Bayer AG, 51368 Leverkusen, Germany
Kerendia is indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults.
For study results with respect to renal and cardiovascular events, see section 5.1.
Kerendia is indicated for the treatment of symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥40% in adults.
The recommended target dose is 20 mg finerenone once daily.
The maximum recommended dose is 20 mg finerenone once daily.
Serum potassium and estimated glomerular filtration rate (eGFR) have to be measured to determine if finerenone treatment can be initiated (see also section 4.4) and to determine the starting dose.
For monitoring of serum potassium, see below 'Continuation of treatment'.
If serum potassium ≤4.8 mmol/L, finerenone treatment can be initiated.
If serum potassium >4.8 to 5.0 mmol/L, initiation of finerenone treatment may be considered with additional serum potassium monitoring within the first 4 weeks based on patient characteristics and serum potassium levels (see section 4.4).
If serum potassium >5.0 mmol/L, finerenone treatment should not be initiated (see section 4.4).
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 increase in dose (see table 2 to determine continuation of finerenone treatment and dose adjustment).
Thereafter, serum potassium has to be remeasured periodically and as needed based on patient characteristics and serum potassium levels.
See sections 4.4 and 4.5 for more information.
Table 2. Continuation of finerenone treatment and dose adjustment:
| Current finerenone dose (once daily) | |||
| 10 mg | 20 mg | ||
| Current serum potassium (mmol/L) | ≤4.8 | Increase to 20 mg finerenone once daily* | Maintain 20 mg once daily |
| >4.8 to 5.5 | Maintain 10 mg once daily | Maintain 20 mg once daily | |
| >5.5 | Withhold finerenone. Consider re-starting at 10 mg once daily when serum potassium ≤5.0 mmol/L. | Withhold finerenone. Re-start at 10 mg once daily when serum potassium ≤5.0 mmol/L. | |
* maintain 10 mg once daily, if eGFR has decreased >30% compared to the previous measurement
The recommended target dose depends on renal function (eGFR) at initiation of finerenone treatment (see table 4):
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 (see also section 4.4) 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 3.
Table 3. 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 4 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.
See sections 4.4 and 4.5 for more information.
Table 4. 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.
No dose adjustment is necessary in elderly patients (see section 5.2) but regular monitoring of renal function is recommended (see section 4.4).
Initiation of treatment:
In patients with eGFR <25 mL/min/1.73 m², finerenone treatment should not be initiated due to limited clinical data (see sections 4.4 and 5.2).
Continuation of treatment:
In patients with eGFR ≥15 mL/min/1.73 m², finerenone treatment can be continued with dose adjustment based on serum potassium. eGFR should be measured 4 weeks after initiation to determine whether the starting dose can be increased (see 'Posology, Continuation of treatment' and tables 2 and 4).
Due to limited clinical data, finerenone treatment should be discontinued in patients who have progressed to end-stage renal disease (eGFR <15 mL/min/1.73 m²) (see section 4.4).
Patients with
In patients taking finerenone concomitantly with moderate or weak CYP3A4 inhibitors, potassium supplements, trimethoprim, or trimethoprim/sulfamethoxazole, additional serum potassium monitoring and adaptation of monitoring according to patient characteristics should be considered (see section 4.4). Finerenone treatment decisions should be made as directed in tables 2 and 4 (see 'Posology, Continuation of treatment'). Temporary discontinuation of finerenone may be necessary, when patients have to take trimethoprim, or trimethoprim/sulfamethoxazole. See sections 4.4 and 4.5 for more information.
No dose adjustment is necessary based on body weight (see section 5.2).
The safety and efficacy of finerenone in children and adolescents aged under 18 years have not yet been established. No data are available.
Oral use.
Tablets may be taken with a glass of water and with or without food (see section 5.2). Tablets should not be taken with grapefruit or grapefruit juice (see section 4.5).
For patients who are unable to swallow whole tablets, Kerendia tablets may be crushed and mixed with water or soft foods, such as apple sauce, directly before oral use (see section 5.2).
The most likely manifestation of overdose is anticipated to be hyperkalaemia. If hyperkalaemia develops, standard treatment should be initiated.
Finerenone is unlikely to be efficiently removed by haemodialysis given its fraction bound to plasma proteins of about 90%.
3 years.
This medicinal product does not require any special storage conditions.
PVC/PVDC/Aluminium transparent calendarised blisters with 14 film-coated tablets. Pack sizes of 14, 28 or 98 film-coated tablets.
PVC/PVDC/Aluminium transparent perforated unit dose blisters with 10 x 1 film-coated tablets. Pack size of 100 × 1 film-coated tablets.
White opaque HDPE bottle with white opaque polypropylene child-resistant screw cap with sealing insert. Pack size of 100 film-coated tablets (Kerendia 10 mg and 20 mg film-coated tablets, only).
Not all pack sizes may be marketed.
This medicinal product may pose a risk to the environment (see section 5.3).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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