Kerendia Dosage/Direction for Use

Dosage (dose and interval): The recommended target dose of KERENDIA is 20 mg once daily.
Initiation of treatment: Initiation of KERENDIA treatment is recommended when serum potassium ≤4.8 mmol/L.
For monitoring of serum potassium, see Continuation of treatment as follows.
If serum potassium >4.8 to 5.0 mmol/L, initiation of KERENDIA treatment may be considered with additional serum potassium monitoring within the first 4 weeks based on patient characteristics and serum potassium levels (see Precautions).
If serum potassium >5.0 mmol/L, initiation of KERENDIA treatment is not recommended (see Precautions).
Measure estimated glomerular filtration rate (eGFR) to determine the starting dose. The starting dose of KERENDIA is: 20 mg once daily if eGFR ≥60 mL/min/1.73 m²; 10 mg once daily if eGFR ≥25 to <60 mL/min/1.73 m².
Initiation of KERENDIA treatment is not recommended in patients with eGFR <25 mL/min/1.73 m² as clinical experience is limited.
Continuation of treatment: Four weeks after initiation or restart or up-titration of KERENDIA treatment, remeasure serum potassium and eGFR. See Table 2 to determine continuation of KERENDIA treatment and dose adjustment. Thereafter, remeasure serum potassium periodically and as needed based on patient characteristics and serum potassium levels. (See Precautions and Interactions.) (See Table 2.)

Click on icon to see table/diagram/image

Method of administration: Oral use.
Tablets may be taken with a glass of water and with or without food (see Pharmacology: Pharmacokinetics under Actions).
Avoid taking KERENDIA with grapefruit or grapefruit juice (see Precautions and Interactions).
For patients who are unable to swallow whole tablets, KERENDIA tablet may be crushed and mixed with water or soft foods, such as apple sauce, immediately prior to use and administered orally (see Pharmacology: Pharmacokinetics under Actions).
Missed dose: A missed dose should be taken as soon as possible after it is noticed, but only on the same day. If this is not possible, the dose should be skipped and the next dose taken as prescribed. Two doses should not be taken to make up for a missed dose.
The maximum daily dose of KERENDIA is 20 mg.
Patients with hepatic impairment: In patients with severe hepatic impairment (Child Pugh C), avoid treatment with KERENDIA (see Precautions and Pharmacology: Pharmacokinetics under Actions). In patients with mild or moderate hepatic impairment, no initial dose adjustment is required (Child Pugh A or B) (see Pharmacology: Pharmacokinetics under Actions).
In patients with moderate hepatic impairment (Child Pugh B), consider additional serum potassium monitoring and adapt monitoring according to patient characteristics (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Patients with renal impairment: Initiation of KERENDIA treatment: In patients with eGFR ≥25 to <60 mL/min/1.73 m², the starting dose of KERENDIA is 10 mg once daily. See Initiation of treatment as previously mentioned.
In patients with eGFR <25 mL/min/1.73 m², initiation of KERENDIA treatment is not recommended as clinical experience is limited (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Continuation of KERENDIA treatment: In patients with mild, moderate or severe renal impairment, continue KERENDIA treatment and adjust dose based on serum potassium. Measure eGFR 4 weeks after initiation to determine up-titration. See Table 2 and Continuation of treatment as previously mentioned.
In patients with end-stage renal disease (eGFR <15 mL/min/1.73 m²), continue KERENDIA treatment with caution regarding serum potassium levels as clinical experience is limited (see Precautions).
Patients taking concomitant medications: In patients taking KERENDIA concomitantly with moderate or weak CYP3A4 inhibitors, potassium supplements, trimethoprim, or trimethoprim-sulfamethoxazole, consider additional serum potassium monitoring and adapt monitoring according to patient characteristics, and make KERENDIA treatment decisions as directed in Table 2. Temporary discontinuation of KERENDIA when taking trimethoprim, or trimethoprim-sulfamethoxazole, may be necessary (see Precautions and Interactions).
Elderly patients: No dose adjustment is required in the elderly (see Pharmacology: Pharmacokinetics under Actions).