NEW INDICATION
Explore the FINEARTS-HF* clinical data that supports the new indication of KERENDIA for heart failure with left ventricular ejection fraction (HF LVEF) ≥40%, along with key dosing and access information.1,2
Study Design
FINEARTS-HF*: The only MRA trial leading to FDA approval for adult patients with HF LVEF ≥40%1,2
FINEARTS-HF was a phase 3, randomized, double-blind, placebo-controlled, multicenter study with a median follow-up period of 2.7 years1
Select inclusion criteria1,2:
- Adults aged ≥40 years
- Diagnosis of HF (NYHA Class II-IV), ambulatory or hospitalized primarily for HF
- LVEF ≥40% documented ≤12 months ago
- On diuretic treatment at least 30 days prior to randomization
- Elevated levels of natriuretic peptides†
Select exclusion criteria2:
- MI or any event that could have reduced the EF within 90 days prior to randomization
- eGFR <25 mL/min/1.73 m2 at screening or randomization
- Serum potassium >5.0 mEq/L at screening or randomization
Select baseline patient characteristics1,2:
- Mean age: 72 years
- Mean LVEF: 53%
- LVEF ≥50%: 64%
- NYHA Class II: 69%
- NYHA Class III: 30%
- Median NT-proBNP: 1041 pg/mL
- Mean eGFR: 62 mL/min/1.73 m2
- eGFR <60 mL/min/1.73 m2: 48%
- Randomized ≤7 days from HF event: 20%
- Loop diuretics: 87%
- ACEi or ARB: 79%
- ARNi: 9%
- SGLT2i: 14%
- GLP-1: 2.8%
*In the FINEARTS-HF trial, HF LVEF ≥40% was defined as HFmrEF or HFpEF.2
†Elevated natriuretic peptide levels were defined as
NT-proBNP ≥300 pg/mL (or BNP ≥100 pg/mL) in patients with sinus rhythm and no ongoing diagnosis of paroxysmal atrial fibrillation, or NT-proBNP
≥900 pg/mL (or BNP ≥300 pg/mL) in patients with atrial fibrillation.2
ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin receptor blocker; ARNi=angiotensin receptor-neprilysin inhibitor; BNP=B-type natriuretic peptide; CV=cardiovascular; EF=ejection fraction; eGFR=estimated glomerular filtration rate; GLP-1=glucagon-like peptide-1; HF=heart failure; HF LVEF=heart failure with left ventricular ejection fraction; HFmrEF=heart failure with mildly reduced ejection fraction; HFpEF=heart failure with preserved ejection fraction; LVEF=left ventricular ejection fraction; MI=myocardial infarction; MRA=mineralocorticoid receptor antagonist; NT-proBNP=N-terminal pro-B-type natriuretic peptide; NYHA=New York Heart Association; SGLT2i=sodium-glucose cotransporter 2 inhibitor.
Primary Composite Endpoint
In the FINEARTS-HF trial of adult patients with HF LVEF ≥40%
KERENDIA significantly reduced the composite risk of CV death and total HF events1*
- Total HF events*: 18% RRR vs placebo (RR=0.82 [95% CI: 0.71-0.94]; P=0.006)1
- CV death: 7% RRR vs placebo (RR=0.93 [95% CI: 0.78-1.11])1
*An HF event was defined as first or recurrent hospitalization for heart failure or urgent visit for heart failure.2
†In a prespecified sensitivity analysis, the time to first HF event or CV death was evaluated at month 36 to calculate NNT and ARR, as determined by the FINEARTS-HF Steering Committee (RR=0.84 [95% CI: 0.76-0.94]).2,4
ARR=absolute risk reduction; CV=cardiovascular; HF=heart failure; HF LVEF=heart failure with left ventricular ejection fraction; NNT=number needed to treat; RR=rate ratio; RRR=relative risk reduction.
subgroup analysis
In a prespecified exploratory subgroup analysis
KERENDIA showed a consistent treatment effect across all subgroups, including SGLT2i use1
Treatment effect with or without baseline SGLT2i use1,5
Adapted from Vaduganathan M, Claggett BL, Kulac IJ, et al. Effects of the nonsteroidal MRA finerenone with and without concomitant SGLT2 inhibitor use in heart failure. Circulation. 2025;151(2):149-158.
Additional prespecified exploratory subgroups with consistent treatment effect include1:
All prespecified exploratory subgroups were underpowered. Results should be interpreted with caution.2
Prespecified exploratory subgroup analyses of primary composite endpoint2
ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin receptor blocker; ARNi=angiotensin receptor-neprilysin inhibitor; CV=cardiovascular; eGFR=estimated glomerular filtration rate; HF=heart failure; LVEF=left ventricular ejection fraction; NT-proBNP=N-terminal pro-B-type natriuretic peptide; NYHA=New York Heart Association; SGLT2i=sodium-glucose cotransporter 2 inhibitor; UACR=urine albumin-to-creatinine ratio.
*Mean cumulative events for the composite of CV death and total HF events. An HF event was defined as first or recurrent hospitalization for heart failure or urgent visit for heart failure.2,5
ARR=absolute risk reduction; CV=cardiovascular; eGFR=estimated glomerular filtration rate; HF=heart failure; LVEF=left ventricular ejection fraction; NYHA=New York Heart Association; PY=patient year; RR=rate ratio; SGLT2i=sodium-glucose cotransporter 2 inhibitor.
Safety
FINEARTS-HF evaluated ~6000 adult patients with HF LVEF ≥40% taking KERENDIA or placebo
KERENDIA has a generally well-tolerated safety profile1,4
Adverse reactions in ≥1% of patients on KERENDIA and more frequently than placebo1,2,4
Adverse reactions related to worsening renal function were reported more frequently in the KERENDIA group (18%) vs placebo (12%) in FINEARTS-HF. The most frequently reported adverse reactions included renal impairment (7% vs 4%), eGFR decreased (5% vs 4%), acute kidney injury (4% vs 2%), and renal failure (3% vs 2%). The majority of events were reported to be mild to moderate. These events led to dose modifications in 9% receiving KERENDIA vs 4% receiving placebo. Hospitalization due to events related to worsening of renal function for the KERENDIA group was 2.0% vs 1.3% with placebo.1
Incidence of select sex-related adverse effects was similar between KERENDIA and placebo6
*Includes breast and nipple tenderness.6
†Includes uterine, vaginal, and postmenopausal bleeding.6
Use in pregnancy: There are no available data on KERENDIA use in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies have shown developmental toxicity at exposures about 2 times those expected in humans. The clinical significance of these findings is unclear.1
Initiation of KERENDIA may cause an initial small increase in blood creatinine levels (mean change <0.1 mg/dL) and a small decrease in eGFR (mean change 2 to 3 ml/min) that occurs within the first 4 weeks of starting therapy then stabilizes. These changes were reversible after treatment discontinuation. Initiation of KERENDIA may also cause a small increase in serum uric acid. This increase appears to attenuate over time.1
Permanent discontinuations due to adverse events were similar between KERENDIA and placebo (3.2% vs 2.8%, respectively)4
eGFR=estimated glomerular filtration rate; HF LVEF=heart failure with left ventricular ejection fractiion.
dosing
For your adult patients with HF LVEF ≥40%
Include once-daily KERENDIA for your patients’ treatment plan1
*If repeated serum potassium measurements are ≥5.5 mEq/L, restart KERENDIA at 10 mg once daily when serum potassium is <5.0 mEq/L.1
†If eGFR has decreased by more than 30% compared to previous measurement, maintain current dose.1
‡For patients taking the 10-mg dose, withhold KERENDIA if serum potassium is ≥5.5 to <6.0 mEq/L, and restart at 10 mg if serum potassium is <5.5 mEq/L.1
Additional dosing information1:
- For patients who are unable to swallow whole tablets, KERENDIA may be crushed and mixed with water or soft foods, such as applesauce, immediately prior to use and administered orally
- Avoid taking KERENDIA with grapefruit or grapefruit juice
- Direct a patient to take a missed dose as soon as possible after it is noticed, but only on the same day. If this is not possible, the patient should skip the dose and continue with the next dose as prescribed
eGFR=estimated glomerular filtration rate; HF LVEF=heart failure with left ventricular ejection fraction; K+=potassium.
Access Resources
Resources to help support patient access to KERENDIA:
Prior Authorization (PA) and Appeal Checklist
- A useful resource outlining best practices, key documentation, and criteria needed for appeal submissions.
Sample Letters of Medical Exception
- Downloadable, templated letters providing clinical justification for KERENDIA when it is not included on a patient’s formulary or prescription drug list.
Sample Letters of Appeal
- Downloadable, templated letters designed to support appeal efforts following a PA or medical exception denial. The letter can be tailored to address specific denial reasons and include supporting evidence, as needed, or requests by the health plan.
Sample Letters of Medical Necessity
- Downloadable, templated letters designed to support the medical necessity of KERENDIA when patients do not meet full PA or step therapy criteria, or when it’s not covered by their plan. The letter can be submitted along with a Tiering Exception Request, Medical Exception Request, or Letter of Appeal.
Prior Authorization (PA) and Appeal Checklist
- A useful resource outlining best practices, key documentation, and criteria needed for appeal submissions.
Sample Letters of Appeal
- Downloadable, templated letters designed to support appeal efforts following a PA or medical exception denial. The letter can be tailored to address specific denial reasons and include supporting evidence, as needed, or requests by the health plan.
Sample Letters of Medical Exception
- Downloadable, templated letters providing clinical justification for KERENDIA when it is not included on a patient’s formulary or prescription drug list.
Sample Letters of Medical Necessity
- Downloadable, templated letters designed to support the medical necessity of KERENDIA when patients do not meet full PA or step therapy criteria, or when it’s not covered by their plan. The letter can be submitted along with a Tiering Exception Request, Medical Exception Request, or Letter of Appeal.
PA=prior authorization.
References:
- Kerendia (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc; July 2025.
- Solomon SD, et al. N Engl J Med. 2024;391(16):1475-1485. doi:10.1056/NEJMoa2407107.
- Vaduganathan M, et al. J Am Coll Cardiol. 2025;85(2):199-202. doi:10.1016./j.jacc.2024.09.018.
- Data on file, Bayer. As of July 2025.
- Vaduganathan M, et al. Circulation. 2025;151(2):149-158. doi:10.1161/CIRCULATIONAHA.124.072055.
- Chimura M, et al. JAMA Cardiol. 2025;10(1):59-70. doi:10.1001/jamacardio.2024.4613.
INDICATION:
- KERENDIA (finerenone) 10mg, 20mg, 40mg tablets is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40%
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS:
- Hypersensitivity to any component of this product
- Concomitant use with strong CYP3A4 inhibitors
- Patients with adrenal insufficiency
WARNINGS AND PRECAUTIONS:
Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and estimated glomerular filtration rate (eGFR) in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5 mEq/L
Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium
Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed
Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly. Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m2 is not recommended. Measure eGFR periodically during maintenance treatment with KERENDIA in patients with heart failure. Consider delaying up-titration or interrupting treatment with KERENDIA in patients who develop clinically significant worsening of renal function
MOST COMMON ADVERSE REACTIONS:
- From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%). Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%)
DRUG INTERACTIONS:
- Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice
- Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor, and adjust KERENDIA dosage as appropriate
- Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers
- Sensitive CYP2C8 Substrates at KERENDIA 40mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40mg is co-administered with such substrates, since minimal concentration changes may lead to serious adverse reactions
USE IN SPECIFIC POPULATIONS:
- Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment
- Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B)
Please see the full Prescribing Information for KERENDIA.
