Posology : מינונים

5. DOSAGE AND ADMINISTRATION
5.1 Prior to Initiation of Kerendia
Measure serum potassium levels and estimated glomerular filtration rate (eGFR) before initiation. Do not initiate treatment if serum potassium is > 5.0 mEq/L [see Warnings and Precautions (7.1)].
5.2 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/1.73m2)                     Starting Dose
≥ 60                             20 mg once daily
≥ 25 to < 60                        10 mg once daily
< 25                            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 [see Clinical Pharmacology (13.3)].
5.3 Monitoring and Dose Adjustment
The target daily dose of Kerendia is 20 mg.
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 judgement and serum potassium levels [see Warnings and Precautions (7.1)]. Monitor serum potassium 4 weeks after a dose adjustment and throughout treatment, and adjust the dose as needed (see Table 2) [see Warnings and Precautions (7.1) and Drug Interactions (9.1)].

Table 2: Dose Adjustment Based on Current Serum Potassium Concentration and Current Dose 
Current Kerendia Dose
10 mg once daily                                  20 mg once daily
≤ 4.8       Increase the dose to 20 mg once daily.*               Maintain 20 mg once daily.
Current > 4.8 – 5.5 Maintain 10 mg once daily.                                        Maintain 20 mg once daily.
Serum
Potassium            Withhold Kerendia.                                                Withhold Kerendia.
(mEq/L)    > 5.5    Consider restarting at 10 mg once daily                           Restart at 10 mg once daily when when serum potassium ≤ 5.0 mEq/L.                                 serum potassium ≤ 5.0 mEq/L.
* If eGFR has decreased by more than 30% compared to previous measurement, maintain 10 mg dose.


5.4 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.