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Kerendia確能達

Kerendia

finerenone

Manufacturer:

Bayer

Distributor:

Zuellig
Concise Prescribing Info
Contents
Finerenone
Indications/Uses
Delays progressive decline of kidney function & reduces risk of CV mortality & morbidity in adults w/ CKD (w/ albuminuria) associated w/ type 2 diabetes, in addition to standard of care.
Dosage/Direction for Use
Recommended target dose: 20 mg once daily. Max daily dose: 20 mg. Initiation of treatment Initiate treatment when serum K ≤4.8 mmol/L. Starting dose: Patient w/ eGFR ≥60 mL/min/1.73 m2 20 mg once daily, ≥25 to <60 mL/min/1.73 m2 10 mg once daily. Continuation of treatment Remeasure serum K & eGFR after 4 wk. Serum K ≤4.8 mmol/L Maintain 20 mg once daily. For patients on 10 mg once daily, increase to 20 mg once daily if eGFR has not decreased >30% compared to prior measurement. 4.9-5.5 mmol/L Maintain dose. >5.5 mmol/L Withhold treatment. Restart at 10 mg once daily if serum K ≤5 mmol/L. Patient w/ mild, moderate or severe renal impairment Continue treatment & adjust dose based on serum K.
Administration
May be taken with or without food: May be taken w/ water. May be crushed & mixed w/ water or soft foods (eg, apple sauce) immediately prior to use if unable to swallow whole tab.
Contraindications
Adrenal insufficiency. Concomitant use w/ strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone).
Special Precautions
Risk of hyperkalaemia. Treatment initiation is not recommended if serum K >5 mmol/L & in patients w/ eGFR <25 mL/min/1.73 m2. If serum K >4.8 to 5 mmol/L, treatment initiation may be considered w/ additional serum K monitoring w/in the 1st 4 wk based on patient characteristics & serum K levels. Remeasure serum K & eGFR 4 wk after initiation/restart/up-titration of treatment, & remeasure serum K periodically thereafter & as needed. Caution when continuing treatment in patients w/ ESRD (eGFR <15 mL/min/1.73 m2). Caution when concomitantly taken w/ K supplements; trimethoprim, or trimethoprim-sulfamethoxazole; moderate & weak CYP3A4 inhibitors. Avoid concomitant use w/ K-sparing diuretics; other mineralocorticoid receptor antagonists (MRAs); strong & moderate CYP3A4 inducers; grapefruit or grapefruit juice. Avoid use in patients w/ severe hepatic impairment (Child Pugh C). Consider additional serum K monitoring in patients w/ moderate hepatic impairment (Child Pugh B). Women of childbearing potential should use effective contraception during treatment. May cause embryofetal harm when administered during pregnancy. Do not breastfeed during treatment. Not recommended in paed patients.
Adverse Reactions
Hyperkalaemia. Hyponatremia, hyperuricemia; hypotension; decreased GFR.
Drug Interactions
Marked increase in exposure w/ itraconazole, clarithromycin & other strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin, nefazodone). Increased AUC & Cmax w/ moderate CYP3A4 inhibitors (eg, erythromycin, verapamil) & weak CYP3A4 inhibitors (eg, amiodarone, fluvoxamine). Increased plasma conc w/ grapefruit or grapefruit juice. Marked decrease in plasma conc w/ rifampicin & other strong CYP3A4 inducers (eg, carbamazepine, phenytoin, phenobarb, St. John's wort) or w/ efavirenz & other moderate CYP3A4 inducers. Additive effect on serum K w/ K-sparing diuretics (eg, amiloride, triamterene); other MRAs (eg, eplerenone, spironolactone); K supplements; trimethoprim, or trimethoprim-sulfamethoxazole.
MIMS Class
Diuretics
ATC Classification
C03DA05 - finerenone ; Belongs to the class of aldosterone antagonists. Used in management of chronic kidney disease.
Presentation/Packing
Form
Kerendia tab 10 mg
Packing/Price
28's
Form
Kerendia tab 20 mg
Packing/Price
28's
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