Concise Prescribing Info
Delays progressive decline of kidney function in adults w/ CKD associated w/ type 2 diabetes (w/ albuminuria), in addition to standard of care.
Dosage/Direction for Use
Initiate treatment when serum K ≤4.8 mmol/L. Target dose: 20 mg once daily. Initiation of treatment eGFR ≥60 mL/min/1.73 m2 Starting dose: 20 mg once daily. eGFR ≥25 to <60 mL/min/1.73 m2 Starting dose: 10 mg once daily. Continuation of treatment Re-measure 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 finerenone. Restart at 10 mg once daily if serum K ≤5 mmol/L.
Adrenal insufficiency. Concomitant use w/ strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone).
Special Precautions
Risk of hyperkalaemia. Re-measure serum K & eGFR 4 wk after initiation/restart/up-titration of treatment, & periodically thereafter for serum K & as needed. Treatment initiation is not recommended if serum K >5 mmol/L & in patients w/ eGFR <25 mL/min/1.73 m2. Treatment initiation if serum K >4.8 to 5.0 mmol/L may be considered w/ additional serum K monitoring w/in the 1st 4 wk based on patient characteristics & serum K levels. Caution when continuing treatment in patients w/ end-stage renal disease (eGFR <15 mL/min/1.73 m2). Caution when concomitantly taken w/ moderate or weak CYP3A4 inhibitors, K supplements, trimethoprim, or trimethoprim-sulfamethoxazole. Avoid taking w/ grapefruit or grapefruit juice; K-sparing diuretics; other mineralocorticoid receptor antagonists; strong CYP3A4 inducers (eg, rifampicin, carbamazepine, phenytoin, phenobarb, St. John's wort) or moderate CYP3A4 inducers (eg, efavirenz). Avoid 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; hypotension; decreased GFR.
Drug Interactions
Marked increase in exposure w/ itraconazole, clarithromycin & other strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or 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 mineralocorticoid receptor antagonists (eg, eplerenone, spironolactone); K supplements; trimethoprim, or trimethoprim-sulfamethoxazole.
MIMS Class
ATC Classification
C03DA05 - finerenone ; Belongs to the class of aldosterone antagonists. Used as potassium-sparing diuretics.
Kerendia tab 10 mg
Kerendia tab 20 mg
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