KERENDIA FILM-COATED TABLET 20MG

BAYER (SOUTH EAST ASIA) PTE LTD

BAYER (SOUTH EAST ASIA) PTE LTD

Therapeutic

Prescription Only

TABLET, FILM COATED

**4.2 Dosage and method of administration** **4.2.1 Method of administration** Oral use Tablets may be taken with a glass of water and with or without food _(see section ‘Pharmacokinetic properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. Avoid taking Kerendia with grapefruit or grapefruit juice _(see section_ ‘Special warnings and precautions for use’ _and_ ‘4.5 Interaction with other medicinal products and other forms of interaction’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. For patients who are unable to swallow whole tablets, Kerendia tablet may be crushed and mixed with water or soft foods, such as applesauce, immediately prior to use and administered orally _(see section ‘Pharmacokinetic properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. **4.2.2 Dosage regimen** The recommended target dose of Kerendia is 20 mg once daily. **4.2.2.1 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’. 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 section_ ‘Special warnings and precautions for use’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. If serum potassium > 5.0 mmol/L, initiation of Kerendia treatment is not recommended _(see section_ ‘Special warnings and precautions for use’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. 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. **4.2.2.2 Continuation of treatment** Four weeks after initiation or re-start or up-titration of Kerendia treatment, remeasure serum potassium and eGFR. See Table 1 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 section_ ‘Special warnings and precautions for use’ _and_ ‘4.5 Interaction with other medicinal products and other forms of interaction’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_.  **4.2.2.3 Missed doses** 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. **4.2.3 Additional information on special populations** **4.2.3.1 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 section ‘Initiation of treatment’. In patients with eGFR < 25 mL/min/1.73m2, initiation of Kerendia treatment is not recommended as clinical experience is limited _(see section_ ‘Special warnings and precautions for use’ _and section ‘Pharmacokinetic properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. 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 1 and section ‘Continuation of treatment’. 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 section_ ‘Special warnings and precautions for use’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. **4.2.3.2 Patients with hepatic impairment** In patients with severe hepatic impairment (Child Pugh C), avoid treatment with Kerendia _(see section_ ‘Special warnings and precautions for use’ _and section ‘Pharmacokinetic properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. In patients with mild or moderate hepatic impairment, no initial dose adjustment is required (Child Pugh A or B) _(see section ‘Pharmacokinetic properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. In patients with moderate hepatic impairment (Child Pugh B), consider additional serum potassium monitoring and adapt monitoring according to patient characteristics _(see section_ ‘Special warnings and precautions for use’ _and section ‘Pharmacokinetic properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. **4.2.3.3 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 1. Temporary discontinuation of Kerendia when taking trimethoprim, or trimethoprim-sulfamethoxazole, may be necessary _(see sections_ ‘Special warnings and precautions for use’ _and_ ‘Interaction with other medicinal products and other forms of interaction’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. **4.2.3.4 Pediatric patients** The safety and efficacy of Kerendia have not been established in patients under 18 years of age. Therefore, Kerendia is not recommended for use in pediatric patients. **4.2.3.5 Geriatric patients** No dose adjustment is required in the elderly _(see section ‘Pharmacokinetic properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. **4.2.3.6 Gender** No dose adjustment is required based on gender _(see section ‘Pharmacokinetic properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. **4.2.3.7 Body weight** No dose adjustment is required based on body weight _(see section ‘Pharmacokinetic properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. **4.2.3.8 Ethnic differences** No dose adjustment is required based on ethnic differences _(see section ‘Pharmacokinetic properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. **4.2.3.9 Smoking status** No dose adjustment is required based on smoking status _(see section ‘Pharmacokinetic properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_.