Firialta

Reduce risk of sustained estimated GFR (eGFR) decline, ESRD, CV death, non-fatal MI & hospitalization for heart failure in adults w/ CKD associated w/ type 2 diabetes.

Target dose: 20 mg once daily. Starting dose: eGFR ≥60 mL/min/1.73 m² 20 mg once daily, ≥25 to <60 mL/min/1.73 m² 10 mg once daily. Dose adjustment after 4 wk & thereafter: Serum K ≤4.8 mmol/L Maintain 20 mg once daily, increase dose to 20 mg once daily for patient on 10 mg once daily if eGFR has not decreased >30% from previous measurement, >4.8 to 5.5 mmol/L Maintain dose, >5.5 mmol/L Withhold & restart at 10 mg once daily if serum K ≤5 mmol/L. Max daily dose: 20 mg.

May be taken with or without food: For patients w/ difficulty swallowing, may be crushed & mixed w/ water or soft foods immediately prior to administration.

Addison's disease. Concomitant use w/ strong CYP3A4 inhibitors eg, itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin & nefazodone.

Not recommended to be initiated if serum K is >5 mmol/L & in patients w/ eGFR <25 mL/min/1.73 m². Increased risk of hyperkalemia in patients w/ low eGFR, higher serum K & previous hyperkalemia episodes. Remeasure serum K & eGFR in all patients 4 wk after initiation, restart or up-titration treatment. Avoid concomitant use w/ K-sparing diuretics (eg, amiloride, triamterene), other mineralocorticoid receptor antagonists [MRAs (eg, eplerenone, esaxerenone, spironolactone, canrenone)]; strong (eg, rifampicin, carbamazepine, phenytoin, phenobarb, St. John's wort) or moderate (eg, efavirenz) CYP3A4 inducers. Monitor serum K in concomitant use w/ moderate (eg, erythromycin, verapamil) or weak (eg, amiodarone, fluvoxamine) CYP3A4 inhibitors, K supplements, trimethoprim, or trimethoprim-sulfamethoxazole. Avoid concomitant intake of grapefruit or grapefruit juice. Avoid use in severe hepatic impairment (Child-Pugh C). ESRD (eGFR <15 mL/min/1.73 m²); moderate hepatic impairment (Child-Pugh B). Women of childbearing potential should use effective contraception during treatment. Not to be used during pregnancy & lactation. Not recommended in ped <18 yr.

Hyperkalemia. Hyponatremia, hyperuricemia; hypotension; decreased GFR.

Increased AUC & C_max w/ strong (eg, itraconazole, clarithromycin, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone), moderate (eg, erythromycin, verapamil) or weak (eg, amiodarone, fluvoxamine) CYP3A4 inhibitors. Increased plasma conc w/ grapefruit or grapefruit juice. Decreased plasma conc w/ strong (eg, rifampicin, carbamazepine, phenytoin, phenobarb, St. John's wort) or moderate (eg, efavirenz) CYP3A4 inducers. Increased risk of hyperkalemia w/ medications increasing serum K including K-sparing diuretics (eg, amiloride, triamterene); other MRAs (eg, eplerenone, esaxerenone, spironolactone, canrenone); K supplements; trimethoprim or trimethoprim-sulfamethoxazole.

Other Agents Affecting Metabolism / Other Drugs Acting on the Genito-Urinary System

C03DA05 - finerenone ; Belongs to the class of aldosterone antagonists. Used in management of chronic kidney disease.

B