For your adult patients with CKD associated with T1D

CHANGE THE COURSE

BY REDUCING UACR

After more than three decades without advancement, KERENDIA is moving care forward in CKD in T1D. KERENDIA significantly reduces UACR, an independent marker of CKD progression risk.

Act on elevated UACR

Elevated UACR can signal systemic damage and increased risk of CKD progression in adults with T1D

Proven efficacy

KERENDIA delivered a significant 25% greater reduction in UACR vs placebo over 6 months in adults with CKD associated with T1D

UACR data

Routinely prescribed

More than 330,000 patients have been treated with KERENDIA

Real-world use

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

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 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.

*Up to 3 daily UACR measures were combined into a geometric mean UACR prior to the analysis of the ratio to baseline of geometric mean UACR. ^†Assessment of data for the washout period was conducted using an ANCOVA model for the ratio to baseline in UACR at follow-up with the model including log baseline UACR. ^‡Geometric mean ratio of treatment group ratios to baseline over the study period (ie, average of geometric mean of treatment effect at month 3 and month 6 visits). ^§30 days after last dose of study intervention.

ANCOVA=analysis of covariance; BL=baseline; CI=confidence interval; CKD=chronic kidney disease; LSGM=least-squares geometric mean; T1D=type 1 diabetes; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.

Treatment strategy is based upon individual patient needs and physician discretion.

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.

*IQVIA NPA data, July 2021 to March 2026. Treatments are normalized for 30-day scripts.³¹

AACE=American Association of Clinical Endocrinology; ADA=American Diabetes Association; CKD=chronic kidney disease; ESC=European Society of Cardiology; HCP=healthcare professional; HF LVEF=heart failure with left ventricular ejection fraction; KDIGO=Kidney Disease: Improving Global Outcomes; NPA=National Prescription Audit; T1D=type 1 diabetes; T2D=type 2 diabetes.

REFERENCES

CHANGE THE COURSE

BY REDUCING UACR

Act on elevated UACR

Proven efficacy

Routinely prescribed

KERENDIA is the first proven treatment for CKD associated with T1D in more than 30 years

Reductions in UACR were observed as early as Month 3 and were sustained through Month 6

A treatment choice your peers are already making

Across indications, KERENDIA has:

5+ years

65,000

330,000

KERENDIA is the first proven treatment for CKD
associated with T1D in more than 30 years