KERENDIA

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 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 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. 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 and Continuation of treatment’ table 2).

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 table 2 (see ‘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.

No data are available. 2). 5). 2).

6%). 4. Tabulated list of adverse reactions The safety of finerenone in patients with chronic kidney disease (CKD) and T2D was evaluated in 2 pivotal phase III studies, FIDELIO-DKD (diabetic kidney disease) and FIGARO-DKD. 2 years. 9 years.

The safety of finerenone in patients with heart failure (HF) with LVEF ≥ 40% was evaluated in the phase III study, FINEARTS-HF. 1 years. The adverse reactions observed are listed in table 3. They are classified according to MedDRA system organ class and frequency convention.

Adverse reactions are grouped according to their frequencies in the order of decreasing seriousness.

Frequencies are defined as follows:

Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). 2 mmol/L was observed in the finerenone group compared to placebo, which remained stable thereafter.

9% of placebo-treated patients. 2%). 3% of placebo-treated patients, respectively. 6% in the placebo group. 2% in the placebo group. 2% of placebo-treated patients. 2% in the placebo group. 2% in the placebo group. In all studies, the majority of hyperkalaemia events were mild to moderate and resolved in patients treated with finerenone.

4. 2% of placebo-treated patients. 2%). 1%). 3% of placebo-treated patients. The majority of GFR decreased/blood creatinine increased events were mild or moderate and resolved in patients treated with finerenone. 73 m2) that attenuated over time compared to placebo.

This decrease appeared to be reversible during continuous treatment. 9%). 6% vs. 2% vs. 7% vs. 6% vs. 2% vs. 8%). Overall, most of the reported events related to worsening of renal function were mild to moderate and resolved in patients treated with finerenone.

4. 1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) 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. 1 Therapeutic indications Kerendia is indicated for the treatment of symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥ 40% in adults.

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 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 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. 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 and Continuation of treatment’ table 2).

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 table 2 (see ‘Continuation of treatment’).

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