In adult patients with CKD associated with T2D

In an exploratory analysis of a pharmacodynamic marker, the relative reduction in UACR from baseline to 4 months was 31% greater with KERENDIA compared to placebo1,2

UACR reduction graph key

SD=standard deviation.

SBP and HbA1c over time in the FIDELIO-DKD trial

SBP and HbA1c chart

In patients treated with KERENDIA, the mean SBP decreased by 3 mmHg and the mean DBP decreased by 1-2 mmHg at month 1, remaining stable thereafter.1

SBP and HbA1c chart 2

Approximately 97% of patients were on an antidiabetic agent.1

DBP=diastolic blood pressure; HbA1C=glycated hemoglobin; SBP=systolic blood pressure.

IMPORTANT SAFETY INFORMATION AND INDICATION

INDICATION:

  • KERENDIA is indicated to reduce the risk of sustained 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)

CONTRAINDICATIONS:

  • 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 >5.0 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

MOST COMMON ADVERSE REACTIONS:

  • Adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo: hyperkalemia (18.3% vs. 9%), hypotension (4.8% vs. 3.4%), and hyponatremia (1.4% vs. 0.7%)

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

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)

INDICATION:

  • KERENDIA is indicated to reduce the risk of sustained 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)

Please read the Prescribing Information for KERENDIA.

References:

  • KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; July 2021. Return to content
  • Bakris GL, et al; FIDELIO-DKD Investigators. N Engl J Med. 2020;383(23):2219-2229. Return to content