CHANGE THE COURSE OF CARE

Act at UACR ≥30 mg/g

Detection of persistent UACR ≥30 mg/g is crucial to identify CKD and is an urgent signal of CV risk in patients with T2D

KERENDIA was proven to reduce CV risk

KERENDIA reduced the risk of CV death, nonfatal MI, and composite HHF, in adults with CKD associated with T2D

CV data

Guidelines recommend KERENDIA

KERENDIA is a core treatment pillar supported by experts and used by peers to reduce CV risk and slow CKD progression, in adults with CKD associated with T2D

Guidelines

CKD=chronic kidney disease; CV=cardiovascular; HHF=hospitalization for heart failure; MI=myocardial infarction; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

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 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:

CKD associated with T2D: From the pooled data of FIDELIO-DKD and FIGARO-DKD, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3%), and hyponatremia (1.3% vs 0.7%).
HF LVEF ≥40%: 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).

INDICATIONS:

KERENDIA (finerenone) is indicated to 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 (T2D) (10mg, 20mg tablets)
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% (10mg, 20mg, 40mg tablets)

Please see the full Prescribing Information for KERENDIA.

CI=confidence interval; CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration rate; HR=hazard ratio; RR=relative reduction; RRR=relative risk reduction; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.

Recommendations with an A rating are based on large, well-designed clinical trials or well-done meta-analyses. Generally, these recommendations have the best chance of improving outcomes when applied to the population to which they are appropriate. Level 1A recommendations are based on a randomized, controlled clinical trial. Level 2A recommendations are based on secular trends, such as those from correlational studies.

*At maximum-tolerated dose. ^†IQVIA NPA data, July 2021 to March 2026. Treatments are normalized for 30-day scripts.

AACE=American Association of Clinical Endocrinology; ACEi=angiotensin-converting enzyme inhibitor; ADA=American Diabetes Association; ARB=angiotensin receptor blocker; CKD=chronic kidney disease; CV=cardiovascular; ESC=European Society of Cardiology; GLP-1 RA=glucagon-like peptide-1 receptor agonist; KDIGO=Kidney Disease: Improving Global Outcomes; MRA=mineralocorticoid receptor antagonist; NPA=National Prescription Audit; SGLT2i=sodium-glucose cotransporter 2 inhibitor; T2D=type 2 diabetes.

REFERENCES

CHANGE THE COURSE OF CARE

Act at UACR ≥30 mg/g

KERENDIA was proven to reduce CV risk

Guidelines recommend KERENDIA

Primary CV composite endpoint

Exploratory analysis¹

Primary renal composite endpoint

Exploratory analysis¹

Secondary CV composite endpoint

REFERENCES

CHANGE THE COURSE OF CARE

Act at UACR ≥30 mg/g

KERENDIA was proven to reduce CV risk

Guidelines recommend KERENDIA

KERENDIA for CKD associated with T2D: efficacy and safety overview

Primary CV composite endpoint

Exploratory analysis1

Secondary renal composite endpoint

Primary renal composite endpoint

Exploratory analysis1

Secondary CV composite endpoint

Safety: pooled data FIGARO-DKD and FIDELIO-DKD1

Initiate KERENDIA—a core treatment pillar supported by experts and used by peers

KERENDIA is recommended by multiple guidelines

Exploratory analysis¹

Exploratory analysis¹

Safety: pooled data FIGARO-DKD and FIDELIO-DKD¹