In adult patients with CKD associated with T2D
The safety profile of KERENDIA was evaluated in more than 13,000 patients1
Adverse reactions reported in ≥1% of patients taking KERENDIA and more commonly than placebo (pooled data from FIGARO-DKD and FIDELIO-DKD)1,2
- Initiation of KERENDIA may cause an initial small decrease in eGFR that occurs within the first 4 weeks of starting therapy, and then stabilizes. In a study that included patients with CKD associated with T2D, this decrease was reversible after treatment discontinuation1
- Initiation of KERENDIA may also cause a small increase in serum uric acid. This increase appears to attenuate over time1
- There were no hyperkalemia events that led to death in patients taking KERENDIA or placebo2
CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate; T2D=type 2 diabetes.
Start your patients on once-daily KERENDIA with 3 steps1
*If serum potassium levels are >4.8 to 5.0 mEq/L, initiation may be considered with additional potassium monitoring within the first 4 weeks based on clinical judgment and serum potassium levels.1
†If eGFR has decreased by more than 30% compared to previous measurement, maintain 10-mg dose.1
Monitor serum potassium 4 weeks after a dose adjustment, and throughout treatment, and adjust the dose as needed.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
- Missed doses:
- 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.
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:
- From the pooled data of 2 placebo-controlled studies, 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 3.9%), and hyponatremia (1.3% 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.; September 2022. 2. Agarwal R, et al. Eur Heart J. 2022;43(6):474-484. doi:10.1093/eurheartj/ehab777.
