Finerenonedosage

The recommended starting dosage is 10 mg or 20 mg orally once daily based on eGFR and serum potassium thresholds. Increase dosage after 4 weeks to the target dose of 20 mg once daily for CKD and T2DM based on eGFR and serum potassium thresholds. Increase dosage after 4 weeks to the target dose of 20 mg or 40 mg once daily for HF with LVEF ≥ 40% based on eGFR and serum potassium thresholds. Tablets may be taken with or without food

2.1 Prior to

Initiation of Kerendia Measure serum potassium levels and eGFR before initiation. Do not initiate treatment if serum potassium is > 5.0 mEq/L.

2.2 Recommended

Starting Dosage The recommended starting dose of Kerendia is based on eGFR and is presented in Table 1.

Table 1: Recommended Starting Dosage eGFR (mL/min/1.73m 2 ) Starting Dose ≥ 60 20 mg orally once daily ≥ 25 to < 60 10 mg orally once daily < 25 Initiation is not recommended For patients who are unable to swallow whole tablets, Kerendia may be crushed and mixed with water or soft foods such as applesauce immediately prior to use and administered orally.

2.3 Monitoring and

Dosage Adjustment CKD associated with T2DM The target daily dose of Kerendia is 20 mg orally. Measure serum potassium 4 weeks after initiating treatment and adjust dose (see Table 2 ); if serum potassium levels are > 4.8 to 5.0 mEq/L, initiation of Kerendia treatment may be considered with additional serum potassium monitoring within the first 4 weeks based on clinical judgment and serum potassium levels. Measure serum potassium 4 weeks after a dose adjustment and periodically throughout treatment, and adjust the dose as needed (see Table 2 ).

Table 2: Dose Adjustment Based on Current Serum Potassium Concentration and Current Dose (CKD associated with T2DM) Current Kerendia Dose 10 mg once daily 20 mg once daily Current Serum Potassium (mEq/L) ≤ 4.8 Increase the dose to 20 mg once daily. If eGFR has decreased by more than 30% compared to previous measurement, maintain 10 mg dose. Maintain 20 mg once daily. > 4.8 – 5.5 Maintain 10 mg once daily. Maintain 20 mg once daily. >

5.5 Withhold

Kerendia. Consider restarting at 10 mg once daily when serum potassium ≤ 5.0 mEq/L. Withhold Kerendia. Restart at 10 mg once daily when serum potassium ≤ 5.0 mEq/L. Heart Failure with LVEF ≥ 40% The target daily dose of Kerendia for heart failure (LVEF ≥ 40%) is dependent on renal function (eGFR) at initiation of Kerendia treatment (see Table 3 ). The target daily dose is 40 mg orally once daily if eGFR at initiation is ≥ 60 mL/min/1.73m 2. The target daily dose is 20 mg orally once daily if eGFR at initiation is ≥ 25 to < 60 mL/min/1.73m 2. Measure serum potassium and eGFR 4 weeks after initiating treatment and adjust dose (see Table 3 ). Measure serum potassium and eGFR 4 weeks after a dose adjustment and monitor periodically throughout treatment, and adjust the dose as needed (see Table 3 ).

Table 3: Dose Adjustment Based on Current Serum Potassium Concentration, eGFR, and Current Dose (Heart Failure (LVEF ≥ 40%)) Current Kerendia Dose 10 mg once daily 20 mg once daily 40 mg once daily Current Serum Potassium (mEq/L) <

5.0 Increase the dose to 20 mg once daily

If eGFR has decreased by more than 30% compared to previous measurement, maintain current dose. Maintain 20 mg once daily if eGFR < 60 mL/min/1.73 m 2 at initiation. Otherwise increase the dose to 40 mg once daily Maintain 40 mg once daily. ≥ 5.0 to < 5.5 Maintain current dose. ≥ 5.5 to <

6.0 Withhold

Kerendia. Restart at 10 mg once daily when serum potassium < 5.5 mEq/L. Decrease to 10 mg once daily. Decrease to 20 mg once daily. ≥

6.0 Withhold

Kerendia. Restart at 10 mg once daily when serum potassium < 5.5 mEq/L. If repeated serum potassium measurements are ≥5.5 mEq/L, restart Kerendia at 10 mg once daily when serum potassium < 5.0 mEq/L.

2.4 Missed Doses

Direct a patient to take a missed dose as soon as possible after it is noticed, but only on the same day. If this is not possible, the patient should skip the dose and continue with the next dose as prescribed.