Kerendia is a new prescription medication used to treat chronic kidney disease associated with type 2 diabetes. It works by blocking mineralocorticoid receptors to reduce worsening of kidney function, kidney failure, cardiovascular death, heart attack, and hospitalization for heart failure. The drug was shown in clinical trials to significantly slow kidney disease progression and reduce cardiovascular risks. It is dosed based on serum potassium levels and kidney function, and common side effects include hyperkalemia, hypotension, and hyponatremia. Careful monitoring of potassium and dose adjustments may be needed.

1. KERENDIA (Finerenone)
a new treatment option for CKD with T2D

2. 1. Indications
2. Disease Overview
3. Mechanism of Action
4. Administration
5. Warnings
6. Patient resources
CONTENTS OF THIS PRESENTATION

3. Indications
Kerendia is a prescription medicine used in adults with chronic
kidney disease with associated type 2 diabetes to reuce the risk of:
 Worsening of the kidney function
 Kidney failure
 Death due to cardiovascular disease
 Heart attack
 Hospitalization for heart failure

4. Clinical Data
In the renal outcomes trial (FIDELIO-DKD) of adult patients with
CKD associated with T2D
 Kerendia significantly slowed CKD progression in addition to
an ACEi or ARB. The treatment effect reflected a reduction in
a sustained decline in eGFR of > 40% and progression to
kidney failure, or renal death
In the CV outcomes trial (FIGARO-DKD) the treatment effect
reflected a reduction of CV death, non-fatal MI, and
hospitalization for HF.

5. Kidney damage for ≥ 3 months as defined by: structural or
functional abnormality of kidney with or without decreased
GFR manifested by either pathologic abnormalities in
composition of blood or urine or abnormalities in imaging tests
OR:
GFR <60 ml/min/1.73m2 for 3 months with or without kidney
damage
Albuminuria :
Albuminuria refers to abnormal loss of albumin in urine
Albumin is one type of plasma protein in urine in normal
subjects and in larger quantity in patients with kidney damage
CKD

6. Classification of Albuminuria
Category Amount of albumin excreted
A1: Normal to mildly increased <30 mg/day (or mg/g)
A2: Moderately increased 30-300mg/day (or mg/g)
A3: Severely increased >300 mg/dl (or mg/g)
Nephrotic Syndrome >2,200 mg/day ( or mg/g)

7. Kerendia is a first-in-class nonsteroidal MR antagonist that blocks
MR overactivation. It blocks MR overactivation in tissues such as
kidneys, heart, and blood vessels.
Mechanism of Action:

8. Dosage and administration:
Kerendia is available as film-coated tablets and available in two strengths: 10 mg, 20
mg. Prior to Initiation of Kerendia check serum potassium levels and estimated
GFR, do not start the treatment if serum potassium is >5 mEq/L
Recommended Starting Dose:

9. Dose adjustment based on current serum
potassium levels and current dose:

10. Drug Interactions
Strong CYP3A4 inhibitor
Cocomitant use of Kerendia with Strong CYP3A4 is contradicted.
 Avoid grapefruit or grapefruit juice
Moderate & weak CYP3A4 Inhibitors
Monitor serum potassium during drug initiation or dosage adjustment of either
Kerendia or weak CYP3A4i and adjust Kerendia dosage
Strong and Moderate CYP3A4 inducers
Avoid concomitant use of Kerendia with strong or moderta CYP3A4 inducers

11. Adverse effects:
In FDA trials:
 Most common ADR: hyperkalemia, hypotension, hyponatremia
 Serious adverse reactions occurred in 32% of patients receiving Kerenida and in
34% of patients receiving placebo. Permanent discontinuation due to adverse
reactions occurred in 7% of patients receiving Kerenida and in 6% of patients
receiving placebo. Hyperkalemia led to permanent discontinuation of treatment in
2.3% of patients receiving Kerendia versus 0.9% patients receiving placebo
In clinical use today: hyperkalemia, hypotension, and
hyponatremia are still the most common adverse effects

12. WARNINGS AND PRECAUTIONS:
HYPERKALEMIA:
 Kerendia can cause hyperkalemia. The risk for
developing hyperkalemia increases with decreasing
kidney function
 Do not initiate Kerendia if serum potassium is >5 mEq/L
 Measure serum potassium periodically during treatment
with Kerendia and adjust dose accordingly

13. CONTRADICTIONS:
 Concomitant use with strong CYP3A4
inhibitors
 Patients with adrenal insufficiency

14. Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph
A, Filippatos G; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in
Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub
2020 Oct 23. PMID: 33264825.
KDIGO – kidney disease | improving global outcomes. https://kdigo.org/wp-
content/uploads/2017/02/KDIGO_2012_CKD_GL.pdf. Accessed February 8, 2023.
Kerendia prescribing information - labeling.bayerhealthcare.com.
https://labeling.bayerhealthcare.com/html/products/pi/Kerendia_PI.pdf. Accessed February 8, 2023.
Kerendia® (finerenone): Healthcare Professionals (HCP). KERENDIA® (finerenone) | Healthcare
Professionals (HCP). https://www.kerendiahcp.com/. Accessed February 8, 2023.
Rico-Mesa JS, White A, Ahmadian-Tehrani A, Anderson AS. Mineralocorticoid Receptor Antagonists: a
Comprehensive Review of Finerenone. Curr Cardiol Rep. 2020 Sep 10;22(11):140. doi: 10.1007/s11886-
020-01399-7. PMID: 32910349.
Sources:

15. Any Questions?