País: Israel
Idioma: inglés
Fuente: Ministry of Health
FINERENON
BAYER ISRAEL LTD
C03DA05
FILM COATED TABLETS
FINERENON 10 MG
PER OS
Required
BAYER AG, GERMANY
FINERENON
Kerendia is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
2023-01-04
1 FULL PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Kerendia 10 mg Kerendia 20 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Kerendia 10 mg film-coated tablets Each film-coated tablet contains 10 mg of finerenone. Kerendia 20 mg film-coated tablets Each film-coated tablet contains 20 mg of finerenone. For the full list of excipients, see section 12. 3. PHARMACEUTICAL FORM Kerendia 10 mg film-coated tablets Pink Film-coated tablet, oval oblong, diameter of 10 mm and radius of curvature of 3.4 mm, Marked with “10” on Top side, and “FI” on the Bottom side Kerendia 20 mg film-coated tablets Pale Yellow Film-coated tablet, oval oblong, diameter of 10 mm and radius of curvature of 3.4 mm, Marked with “20” on Top side, and “FI” on the Bottom side. 4. THERAPEUTIC INDICATIONS Kerendia is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non- fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). 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. 2 TABLE 1: RECOMMENDED STARTING DOSAGE EGFR (ML/MIN/1.73M 2 ) 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 Leer el documento completo
1 FULL PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Kerendia 10 mg Kerendia 20 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Kerendia 10 mg film-coated tablets Each film-coated tablet contains 10 mg of finerenone. Kerendia 20 mg film-coated tablets Each film-coated tablet contains 20 mg of finerenone. For the full list of excipients, see section 12. 3. PHARMACEUTICAL FORM Kerendia 10 mg film-coated tablets Pink Film-coated tablet, oval oblong, diameter of 10 mm and radius of curvature of 3.4 mm, Marked with “10” on Top side, and “FI” on the Bottom side Kerendia 20 mg film-coated tablets Pale Yellow Film-coated tablet, oval oblong, diameter of 10 mm and radius of curvature of 3.4 mm, Marked with “20” on Top side, and “FI” on the Bottom side. 4. THERAPEUTIC INDICATIONS Kerendia is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non- fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). 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. 2 Table 1: Recommended Starting Dosage eGFR (mL/min/1.73m 2 ) 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 Leer el documento completo