Finerenone

Class
Diuretics
Subclass
Non-steroidal mineralocorticoid receptor antagonists
Substance name
Finerenone
Brand names
Kerendia®
Common formulations
Film-coated tablet, Tablet
Dosage and administration
Adults patients
CKD in patients with diabetes mellitus type 2 • Reduction of decline in renal function, progression to end-stage kidney disease, cardiovascular mortality, and HF hospitalization
•
Start at: 20 mg PO daily
•
Maintenance: 10-20 mg PO daily
Do not initiate treatment if serum potassium is > 5.0 mEq/L.
HF • Ejection fraction ≥ 40%, reduction of cardiovascular death, hospitalization for HF, and urgent HF visits
•
Start at: 20 mg PO daily
•
Maintenance: 40 mg PO daily
Indications for use
Labeled indications
Adults
•
Treatment of CKD in patients with diabetes mellitus type 2 (reduction of decline in renal function, progression to end-stage kidney disease, cardiovascular mortality, and HF hospitalization)
•
Treatment of HF (ejection fraction ≥ 40%, reduction of cardiovascular death, hospitalization for HF, and urgent HF visits)
Safety risks
Contraindications
Adrenal insufficiency
Concomitant use of strong CYP3A4 inhibitors
Concomitant use of strong or moderate CYP3A4 inducers
Warnings and precautions
Increased serum finerenone levels
•
Use caution in patients taking moderate or weak CYP3A4 inhibitors.
Increased serum potassium
•
Use caution in patients with greater renal impairment, higher baseline potassium levels, receiving concomitant therapy with drugs or supplements increasing serum potassium, or other risk factors for hyperkalemia. Measure serum potassium and eGFR before initiating treatment and adjust the dose accordingly. Do not initiate finerenone if serum potassium is > 5.0 mEq/L.
•
Assess serum potassium levels 4 weeks after initiating treatment and after any dose adjustments, then periodically throughout the treatment. Increase the dose to 20 mg if serum potassium is ≤ 4.8 mEq/L in patients taking 10 mg daily. Maintain the dose of 10 mg if serum potassium is between 4.8-5.5 mEq/L or if eGFR decreases by > 30%. Withhold finerenone if serum potassium is > 5.5 mEq/L and resume at 10 mg when it decreases to ≤ 5 mEq/L. Maintain 20 mg if serum potassium is ≤ 5.5 mEq/L in patients taking 20 mg daily. Withhold finerenone if serum potassium is > 5.5 mEq/L and resume at 10 mg when it decreases to ≤ 5 mEq/L.
Specific populations
Renal impairment
eGFR ≥ 60 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required. Monitor renal function. Monitor serum potassium.
eGFR 25-60 mL/min/1.73 m²
•
Start at dose of 10 mg PO daily for CKD. Maximal dose of 20 mg PO daily for HF. Monitor renal function. Monitor serum potassium.
eGFR < 25 mL/min/1.73 m²
•
Do not initiate.
Renal replacement therapy
Any modality
•
No guidance available. Do not initiate.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required. Monitor serum potassium.
Child-Pugh C (severe)
•
Avoid use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Insufficient evidence. Evidence of fetal harm in animals.
Breastfeeding
Do not use during breastfeeding.
•
Advise females not to breastfeed during treatment and for 1 day after the last dose.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
↑ serum potassium
Common 1-10%
•
↓ serum sodium, hypotension
Unknown frequency
•
↑ serum uric acid, ↓ GFR
Interactions
Drug(s)
Check Interactions
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