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In an exploratory analysis of adult patients with CKD associated with T2D

The relative reduction in UACR was 31% greater with KERENDIA vs placebo at month 4 and remained stable thereafter1,2

On top of standard of care, KERENDIA reduced UACR by 31% vs placebo at 4 months

Geometric mean UACR (mg/g) at baseline ± geometric SD:

• KERENDIA: 798.79±2.65

• Placebo: 814.73±2.67

According to the ADA, all patients with T2D should have an assessment of urinary albumin/UACR and eGFR at least annually. Patients with an eGFR 30 to 60 mL/min/1.73 m2 and/or UACR ≥300 mg/g should be monitored twice annually.3

Mean SBP over time in the FIDELIO-DKD trial1,2

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

SBP graph

Mean SBP at baseline ± SD:

KERENDIA: 138.02±14.31

Placebo: 137.98±14.42

Mean HbA1c over time in the FIDELIO-DKD trial1,2

Approximately 97% of patients were on an antidiabetic agent.

HbA1c graph

Mean HbA1c at baseline ± SD:

KERENDIA: 7.66±1.33

Placebo: 7.69±1.36

ADA=American Diabetes Association; CKD=chronic kidney disease; DBP=diastolic blood pressure; eGFR=estimated glomerular filtration rate; HbA1c=glycated hemoglobin; SBP=systolic blood pressure; SD=standard deviation; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.

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)

IMPORTANT SAFETY INFORMATION

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)

Please read the Prescribing Information for KERENDIA.

References: 1. KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; July 2021. 2. Bakris GL, et al; FIDELIO-DKD Investigators. N Engl J Med. 2020;383(23):2219-2229. 3. American Diabetes Association Professional Practice Committee. Chronic kidney disease and risk management: standards of medical care in diabetes—2022. Diabetes Care. 2022;45(suppl 1):S175-S184. doi:10.2337/dc22-S011.