Kerendia

Posology Chronic kidney disease associated with type 2 diabetes (T2D) The recommended target dose is 20 mg finerenone once daily. The maximum recommended dose is 20 mg finerenone once daily. 4) and to determine the starting dose. 8 mmol/L, finerenone treatment can be initiated.

4). 4). The recommended starting dose of finerenone is based on eGFR and is presented in table 1. 73 m2) Starting dose (once daily) ≥ 60 20 mg ≥ 25 to < 60 10 mg < 25 Not recommended Continuation of treatment 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. 5 for more information. 5 Withhold finerenone. 0 mmol/L. Withhold finerenone. 0 mmol/L. 73 m2 The maximum recommended dose is 40 mg finerenone once daily.

0 mmol/L, finerenone treatment can be initiated. 4) and to determine the starting dose. ’ The recommended starting dose of finerenone is based on eGFR and is presented in table 3. 73 m2) Starting dose (once daily) ≥ 60 20 mg ≥ 25 to < 60 10 mg < 25 Not recommended Continuation of treatment 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. 5 for more information. 5 mmol/L. 0 Withhold finerenone. 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. Missed dose 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. 4). 2). 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).

5 Withhold finerenone. 0 mmol/L. Withhold finerenone. 0 mmol/L. 73 m2 The maximum recommended dose is 40 mg finerenone once daily. 0 mmol/L, finerenone treatment can be initiated. 4) and to determine the starting dose. ’ The recommended starting dose of finerenone is based on eGFR and is presented in table 3.

73 m2) Starting dose (once daily) ≥ 60 20 mg ≥ 25 to < 60 10 mg < 25 Not recommended Continuation of treatment 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. 5 for more information. 5 mmol/L. 0 Withhold finerenone. 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. Missed dose 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. 4). 2). 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).

4). 2). No data are available. - moderate hepatic impairment: No initial dose adjustment is required. 2). - mild hepatic impairment: No initial dose adjustment is required. 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. 5 for more information. 2). Paediatric population The safety and efficacy of finerenone in children and adolescents aged under 18 years have not yet been established.

4. Kerendia 20 mg film-coated tablets Each film-coated tablet contains 20 mg of finerenone. 4. Kerendia 40 mg film-coated tablets Each film-coated tablet contains 40 mg of finerenone. 4. 1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Kerendia 10 mg film-coated tablets Pink, oval-oblong film-coated tablet with a length of 10 mm and a width of 5 mm, marked ‘10’ on one side and ‘FI’ on the other side.

Kerendia 20 mg film-coated tablets Pale yellow, oval-oblong film-coated tablet with a length of 10 mm and a width of 5 mm, marked ‘20’ on one side and ‘FI’ on the other side. Kerendia 40 mg film-coated tablets Grey-orange, oval-oblong film-coated tablet with a length of 11 mm and a width of 5 mm, marked ‘40’ on one side and ‘FI’ on the other side.

3 4. 1 Therapeutic indications Kerendia is indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults. 1. Kerendia is indicated for the treatment of symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥ 40% in adults.

2 Posology and method of administration Posology Chronic kidney disease associated with type 2 diabetes (T2D) The recommended target dose is 20 mg finerenone once daily. The maximum recommended dose is 20 mg finerenone once daily. 4) and to determine the starting dose.

8 mmol/L, finerenone treatment can be initiated. 4). 4). The recommended starting dose of finerenone is based on eGFR and is presented in table 1. 73 m2) Starting dose (once daily) ≥ 60 20 mg ≥ 25 to < 60 10 mg < 25 Not recommended Continuation of treatment 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. 5 for more information. 5 Withhold finerenone. 0 mmol/L. Withhold finerenone. 0 mmol/L. 73 m2 The maximum recommended dose is 40 mg finerenone once daily.

1. , - itraconazole - ketoconazole - ritonavir - nelfinavir - cobicistat - clarithromycin - telithromycin - nefazodone - Addison's disease