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Firialta

Firialta

finerenone

Manufacturer:

Bayer AG

Distributor:

Bayer
Concise Prescribing Info
Contents
Finerenone
Indications/Uses
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.
Dosage/Direction for Use
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. If eGFR has not decreased >30% from previous measurement, increase dose to 20 mg once daily for patients on 10 mg once daily, >4.8-5.5 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.
Administration
May be taken with or without food: For patients w/ difficulty swallowing whole tab, tab may be crushed & mixed w/ water or soft foods (eg, applesauce) immediately prior to administration.
Contraindications
Addison's disease. Concomitant use w/ strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin & nefazodone).
Special Precautions
Not recommended to be initiated if serum K is >5 mmol/L & in patients w/ eGFR <25 mL/min/1.73 m2. Remeasure serum K & eGFR in all patients 4 wk after initiation or re-start or uptitration 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 when concomitant use w/ moderate (eg, erythromycin & verapamil) or weak (eg, amiodarone & fluvoxamine) CYP3A4 inhibitors, K supplements, trimethoprim, or trimethoprim-sulfamethoxazole. Temporary discontinuation w/ trimethoprim, or trimethoprim-sulfamethoxazole, may be necessary. Avoid concomitant intake of grapefruit or grapefruit juice. Increased risk of hyperkalemia w/ decreasing renal function. Avoid use in severe hepatic impairment (Child Pugh C). Moderate hepatic impairment (Child Pugh B). Advise women of childbearing potential to use effective contraception during treatment. Pregnancy. Discontinue breastfeeding if therapy is considered essential. Not recommended in ped patients <18 yr.
Adverse Reactions
Hyperkalemia. Hyponatremia, hyperuricemia; hypotension; decreased GFR.
Drug Interactions
Increased AUC & Cmax w/ itraconazole, clarithromycin & other strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone); & exposure w/ moderate (eg, erythromycin & verapamil) or weak (eg, amiodarone & fluvoxamine) CYP3A4 inhibitors. Increased plasma conc w/ grapefruit or grapefruit juice. Decreased plasma conc & reduced therapeutic effect w/ strong (eg, rifampicin, carbamazepine, phenytoin, phenobarb, St. John's wort) or moderate (eg, efavirenz) CYP3A4 inducers. Increased risk of hyperkalemia w/ medications that increase serum K including K-sparing diuretics (eg, amiloride, triamterene); other MRAs (eg, eplerenone, esaxerenone, spironolactone, canrenone); K supplements; trimethoprim, or trimethoprim-sulfamethoxazole.
MIMS Class
Diuretics
ATC Classification
C03DA05 - finerenone ; Belongs to the class of aldosterone antagonists. Used as potassium-sparing diuretics.
Presentation/Packing
Form
Firialta FC tab 10 mg
Packing/Price
100's;28's;98's
Form
Firialta FC tab 20 mg
Packing/Price
100's;28's;98's
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