FINERENONE TAB

Clinical Criteria Summary

Concomitant treatment with strong CYP3A4 inhibitors or strong or moderate CYP3A4 inducers
Adrenal insufficiency
Serum potassium greater than 5.0 mEq/L
Condition where another mineralocorticoid receptor antagonist (i.e., spironolactone or eplerenone) would be indicated (e.g., resistant hypertension, heart failure)
Severe hepatic impairment (Child Pugh class C)
Lactating

Type 2 diabetes mellitus
Chronic kidney disease diagnosis with estimated glomerular filtration rate >= 25 ml/min/1.73m2 AND persistent albuminuria with urinary albumin-to-creatinine ratio>= 30 mg/g
Receiving treatment containing maximum tolerated labeled dose of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) or unable to use an ACEI or ARB
Receiving treatment with a sodium-glucose cotransporter-2 (SGLT2) inhibitor or unable to use an SGLT2 inhibitor
Clinical trial-specific parameters for chronic kidney disease:
FIDELIO-DKD: Persistent albuminuria (urinary albumin-to-creatinine ratio 30 to < 300 mg/g) with eGFR 25 to < 60 ml/min/1.73m2 and diabetic retinopathy; OR persistent albuminuria (UACR 300 to 5000 mg/g) with eGFR 25 to < 70 ml/min/1.73m2
FIGARO-DKD: Persistent albuminuria (UACR 30 to < 300 mg/g) with eGFR 25 to 90 ml/min/1.73m2; OR persistent albuminuria (UACR 300 to 5000 mg/g) with eGFR >= 60 ml/min/1.73m2
Requirement for guideline-directed medical therapy despite ACEI or ARB and SGLT2 inhibitor use

Reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes.

Available as 10 mg and 20 mg tablets.
Recommended starting dose is 10 mg or 20 mg orally once daily, taking into consideration eGFR and serum potassium.
Dose may be increased after 4 weeks to the target dose of 20 mg once daily, based on eGFR and serum potassium thresholds.

Hyperkalemia: Patients with decreased kidney function and higher baseline potassium levels are at increased risk.
Do not initiate finerenone if serum potassium is > 5.0 mEq/L.
Monitor serum potassium levels and adjust dose as needed.

Recommended to reduce CKD progression and cardiovascular events in patients with CKD who are at increased risk for cardiovascular disease progression or CKD progression, or who are unable to use an SGLT2 inhibitor.
Nonsteroidal, selective mineralocorticoid receptor antagonist (MRA).

Patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40% to reduce the risk of cardiovascular (CV) death, HF hospitalization, and urgent HF visits
Applicable to HFpEF (LVEF ≥50%) and HFmrEF (LVEF 41-49%)
Trial population criteria: ≥40 years old, symptomatic HF, LVEF ≥40%, structural heart disease, and elevated natriuretic peptides

Required baseline labs prior to initiation: Serum potassium and estimated renal function (eGFR)
Do not initiate if serum potassium is >5 mEq/L or eGFR <25 mL/min/1.73m2
Initial dose determined by eGFR at time of initiation: 20 mg once daily if eGFR ≥60; 10 mg once daily if eGFR 25 to <60; not recommended for eGFR <25

Dose adjustments made at 4 weeks based on serum potassium level and initial eGFR
Target dose: 40 mg once daily for patients with initial eGFR ≥60 mL/min/1.73m2; 20 mg once daily for patients with initial eGFR ≥25 to <60 mL/min/1.73m2

Monitor serum potassium at 4 weeks after starting treatment and periodically thereafter
Monitor eGFR periodically during treatment
Dose adjustment may be required based on monitoring results

Hypersensitivity to finerenone
Concomitant use of strong CYP3A4 inhibitors
Adrenal insufficiency
Hyperkalemia: Increased risk with worsening renal function, higher baseline potassium levels, or other risk factors; do not initiate if potassium >5 mEq/L
Worsening renal function: Measure eGFR before initiating and periodically; do not initiate if eGFR <25 mL/min/1.73m2

Nonformulary status
FDA indicated for HF with LVEF ≥40%
Not yet specifically included in current HF guidelines (guidelines based on spironolactone evidence)
Primary benefit driven by reduction in HF worsening events; no improvement in CV death, all-cause mortality, or NYHA functional class observed
Nonsteroidal, selective MRA: Not associated with gynecomastia or menstrual irregularities seen with steroidal MRAs
No head-to-head comparisons with other MRAs (including spironolactone) for HFpEF/HFmrEF management

Serum potassium level greater than 5.0 mEq/L
Estimated glomerular filtration rate (eGFR) less than 25 mL/min/1.73m
Severe hepatic impairment (e.g., Child-Pugh class C)
Concomitant treatment with strong CYP3A4 inhibitors or strong or moderate CYP3A4 inducers
Adrenal insufficiency
Lactating

Diagnosis of symptomatic heart failure with a left ventricular ejection fraction (LVEF) of 40% or greater
Receiving treatment with a sodium-glucose cotransporter-2 (SGLT2) inhibitor or unable to use an SGLT2 inhibitor
Intolerance or unable to use spironolactone

For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy
Eplerenone may be considered before finerenone in patients who experience intolerance to spironolactone due to gynecomastia