Active Ingredient: Finerenone
Finerenone is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
10 - 20 mg
From 10 To 20 mg once every day
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 and to determine the starting dose.
If serum potassium ≤4.8 mmol/L, finerenone treatment can be initiated. For monitoring of serum potassium, see below 'Continuation of treatment.'
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.
If serum potassium >5.0 mmol/L, finerenone treatment should not be initiated. 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.
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
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.
Finerenone tablets may be taken with a glass of water and with or without food.
For patients who are unable to swallow whole tablets, the tablets may be crushed and mixed with water or soft foods, such as apple sauce, directly before oral use.
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