KERENDIA is a simple, once-daily, oral treatment option1
Dosing
THE FIRST TREATMENT APPROVED FOR YOUR ADULT PATIENTS WITH CKD ASSOCIATED WITH T1D IN 30+ YEARS1,2
KERENDIA reduces UACR, which is expected to slow CKD progression1,3
For your adult patients with CKD associated with T1D
KERENDIA is a simple, once-daily, oral treatment option1
*If serum potassium levels are >4.8 to 5.0 mEq/L, initiation of KERENDIA treatment may be considered with additional serum 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 current dose.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
- 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
CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate; K+=potassium; T1D=type 1 diabetes.
INDICATIONS:
KERENDIA (finerenone) 10 mg, 20 mg tablets 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)
- reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline and end-stage kidney disease in adults with CKD associated with Type 1 diabetes (T1D)
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.
MOST COMMON ADVERSE REACTIONS:
- 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%).
DRUG INTERACTIONS for KERENDIA 10 mg, 20 mg:
- 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 see the full Prescribing Information for KERENDIA.
