National Broadcast video 3 |Underscoring the Efficacy and Safety of KERENDIA (finerenone)
Underscoring the Efficacy and Safety of KERENDIA (finerenone)
2023-08-16
Investigate the clinical data sets from FIGARO-DKD and FIDELIO-DKD.
Patient resources
Download this brochure to help your patients onboard to KERENDIA. It contains basic information about KERENDIA, as well as available financial and patient support resources.
Download this brochure to educate your patients who are considering taking KERENDIA. It contains information about what KERENDIA does and how to take it safely. It also provides savings and support resources.
Frequently asked questions
UACR, or urinary albumin-to-creatinine ratio, measures kidney damage and is used (along with eGFR) to diagnose CKD and assess risk of CV mortality in patients with CKD. KDIGO recommends that a patient’s CKD be staged based on eGFR, urinary albumin, and cause.1,2
The 2022 ADA Standards of Care recommend assessing both UACR and eGFR at least annually in all patients with T2D, regardless of treatment regimen. Patients with T2D and albuminuria (UACR) ≥300 mg/g and/or eGFR 30 to 60 mL/min/1.73 m² should be monitored at least twice per year. Additionally, for patients with CKD who have urinary albumin >300 mg/g, the ADA recommends a reduction of ≥30% in mg/g urinary albumin to slow CKD progression.3
References: 1. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. Kidney Intl Suppl. 2013;3(1):1-150. doi:10.1038/kisup.2012.73. 2. Campion CG, et al. Can J Kidney Health Dis. 2017;4. doi:10.1177/2054358117705371. 3. American Diabetes Association® Professional Practice Committee; Draznin B, et al. Diabetes Care. 2022;45(suppl 1):S144-S184.
Adult patients with CKD associated with T2D may be appropriate for KERENDIA. Between the 2 phase 3 trials (FIGARO-DKD and FIDELIO-DKD), KERENDIA has been studied in more than 13,000 adult T2D patients across a broad range of CKD severity. The FIGARO-DKD trial studied patients with CKD associated with T2D, defined as either having a UACR of 30 to <300 mg/g and an eGFR of 25 to 90 mL/min/1.73 m2, or as having a UACR of ≥300 mg/g and an eGFR of ≥60 mL/min/1.73 m².¹ The FIDELIO-DKD trial studied patients with CKD associated with T2D, defined as either having a UACR of 30 to <300 mg/g, eGFR 25 to <60 mL/min/1.73 m² and diabetic retinopathy, or as having a UACR of ≥300 mg/g and an eGFR of 25 to <75 mL/min/1.73 m².¹ For more information, visit The KERENDIA patient section of the website.
Reference: 1. KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; September 2022.
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%).1 For more information, visit the Safety and dosing section of the website.
Reference: 1. KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; September 2022.
Access Services by Bayer is working with CoverMyMeds® to provide the support your patients count on with the enhanced services you can trust from CoverMyMeds®. We provide visibility into the entire patient journey and reduce time to therapy through enhanced services within your workflow including appeals support. Go to CoverMyMeds.com to help your patients start KERENDIA today.
If you do not use CoverMyMeds®, Bayer provides sample Letters of Medical Necessity and Medical Exception here.
Offices may also refer to the KERENDIA Prior Authorization and Medical Exceptions Guide for helpful tips when submitting these authorization requests.
The price that each patient pays for KERENDIA depends on what type of prescription drug plan they have and which pharmacy they go to. We are committed to helping your patients start KERENDIA by supporting their insurance and affordability challenges. Patients who need help paying for their KERENDIA prescription should call 1-888-KERENDIA (537-3634) or visit www.KERENDIA.com to learn more about the affordability solutions offered by Bayer.
ADA=American Diabetes Association®; CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate; KDIGO=Kidney Disease: Improving Global Outcomes; 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:
- 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.
