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Add once-daily Firialta to your patients’ current regimen1

01

INITIATION

10 mg if:

  • Serum potassium is ≤4.8 mmol/L, or >4.8 to 5.0 mmol/L with additional monitoring*

and

  • eGFR is ≥25 to <60 mL/min/1.73 m2

20 mg if:

  • Serum potassium is ≤4.8 mmol/L, or >4.8 to 5.0 mmol/L with additional monitoring*

and

  • eGFR is ≥60 mL/min/1.73 m2

02

CHECK LABS

Alt tag

Check serum potassium
and eGFR 4 weeks after:

  • initiation
  • restart
  • increase in dose

and routinely afterwards

03

TITRATION

Serum potassium
(mmol/L)
10 mg
20 mg
≤4.8
Increase to 20 mg if eGFR has not
decreased >30% compared with the
prior measurement
Maintain dose
>4.8 to 5.5
Maintain dose
>5.5
Withhold Firialta and restart at 10 mg when serum
potassium decreases to ≤5.0 mmol/L. Remeasure serum
potassium and eGFR 4 weeks after restart
Serum potassium
(mmol/L)
≤4.8
10 mg Increase to 20 mg if eGFR has not decreased >30% compared with the prior measurement

20 mg Maintain dose
>4.8 to 5.5
Maintain dose
>5.5
Withhold Firialta and restart at 10 mg when serum potassium decreases to ≤5.0 mmol/L. Remeasure serum potassium and eGFR 4 weeks after restart

*If serum potassium is >4.8 to 5.0 mmol/L, initiation of Firialta treatment may be considered with additional serum potassium monitoring within the first 4 weeks based on patient characteristics and serum potassium levels.1

 

  • Continue to routinely monitor serum potassium and eGFR, and titrate Firialta as needed
  • Patients can continue to take commonly prescribed medications including antidiabetic and antihypertensive therapies while on Firialta
  • Patients with eGFR ≥15 mL/min/1.73 m2 can continue Firialta treatment with dose adjustment based on serum potassium†
Potassium management2,3
  • There were no dietary restrictions regarding potassium for patients in the FIDELIO-DKD trial 
  • Potassium-lowering therapies (such as sodium polystyrene sulfonate, calcium polystyrene sulfonate, and potassium-binding agents) were allowed in both trials
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†Firialta should not be initiated in patients with eGFR <25 mL/min/1.73 m2.1

 

eGFR=estimated glomerular filtration rate.

References:

 

Therapeutic Indications: Firialta is indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults. Posology : The recommended target dose is 20 mg finerenone once daily. The maximum recommended dose is 20 mg finerenone once daily. Initiation of treatment: Serum potassium and estimated glomerular filtration rate (eGFR) have to be measured to determine if finerenone treatment can be initiated and to determine the starting dose. If serum potassium 4.8 mmol/L, finerenone treatment can be initiated. For monitoring of serum If serum potassium > 4.8 to 5.0 mmol/L, initiation of finerenone treatment may be considered with additional serum potassium monitoring within the first 4 weeks based on patient characteristics and serum potassium levels. If serum potassium > 5.0 mmol/L, finerenone treatment should not be initiated. The recommended starting dose of finerenone is based on eGFR. If eGFR > 60mL/min/1.73m2, Finerenone 20 mg can be initiated. If eGFR >25 to 60mL/min/1.73m2,start Firialta 10 mg. For patients with If eGFR <25mL/min/1.73m2, initiating Finerenone is not recommended. Continuation of treatment: Serum potassium and eGFR have to be remeasured 4 weeks after initiation or re-start of finerenone treatment or increase in dose. Thereafter, serum potassium has to be remeasured periodically and as needed based on patient characteristics and serum potassium levels. If serum potassium 4.8 mmol/L and patients take Firialta 10 mg, increase the dose to 20 mg Finerenone once daily (Maintain 10 mg once daily, if eGFR has decreased > 30% compared to the previous measurement). If serum potassium 4.8 mmol/L and patients take Firialta 20 mg once daily, maintain it. If serum potassium > 4.8 to 5.5 mmol/L and patients currently use Finerenone 10 mg, maintain 10 mg once daily. If serum potassium > 4.8 to 5.5 mmol/L and patients currently use Firialta 20 mg, maintain 20 mg once daily. If serum potassium >5.5 mmol/L, for patients both with Finerenone 10 mg and 20 mg once daily, withhold finerenone. Consider re-starting at 10 mg once daily when serum potassium <5.0 mmol/L. Missed dose: A missed dose should be taken as soon as the patient notices, but only on the same day.The patient should not take 2 doses to make up for a missed dose. Method of administration: Oral use (Tablets may be taken with a glass of water and with or without food; Tablets should not be taken with grapefruit or grapefruit juice. Crushing of tablets: for patients who are unable to swallow whole tablets, Firialta tablets may be crushed and mixed with water or soft foods, such as apple sauce, directly before oral use. Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; Concomitant treatment with strong inhibitors of CYP3A4 (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone, Addison's disease. Presentation: Firialta 10 mg: Box, 2 Blisters @ 14 Film-coated tablet. Firialta 20 mg: Box, 2 Blisters @ 14 Film-coated tablets

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