Kerendia
Generic: FINERENONE
Basic Information
Manufacturer
Bayer HealthCare Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
fc726765-5d5a-4d6e-b037-b847bda9fb7c
Indications & Usage
1 INDICATIONS AND USAGE Kerendia 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 (T2DM).
cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%.
Kerendia is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) 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 (T2DM).
( 1 ) cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (LVEF) ≥ 40% ( 1 )
cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%.
Kerendia is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) 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 (T2DM).
( 1 ) cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (LVEF) ≥ 40% ( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Hyperkalemia [see Warnings and Precautions (5.1) ] Adverse reactions occurring in ≥ 1% of patients on Kerendia and more frequently than placebo are hyperkalemia, hypotension, and hyponatremia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc.
at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
CKD associated with T2DM The safety of Kerendia in patients with CKD associated with T2DM was evaluated in 2 randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 studies, FIDELIO-DKD and FIGARO-DKD, in which a total of 6510 patients were treated with 10 or 20 mg once daily over a mean duration of 2.2 and 2.9 years, respectively.
Overall, serious adverse events occurred in 32% of patients receiving Kerendia and in 34% of patients receiving placebo in the FIDELIO-DKD study; the findings were similar in the FIGARO-DKD study.
Permanent discontinuations due to adverse events also occurred in a similar proportion of patients in the two studies (6-7% of patients receiving Kerendia and in 5-6% of patients receiving placebo).
The most frequently reported (≥ 10%) adverse reaction was hyperkalemia [see Warnings and Precautions (5.1) ].
Hospitalization due to hyperkalemia for the Kerendia group was 0.9% vs 0.2% in the placebo group across both studies.
Hyperkalemia led to permanent discontinuation of treatment in 1.7% receiving Kerendia versus 0.6% of patients receiving placebo across both studies.
Table 4 shows adverse reactions that occurred more commonly on Kerendia than on placebo, and in at least 1% of patients treated with Kerendia.
Table 4: Adverse reactions reported in ≥ 1% of patients on Kerendia and more frequently than placebo (Pooled data from FIDELIO-DKD and FIGARO-DKD) Adverse reactions Kerendia N = 6510 n (%) Placebo N = 6489 n (%) Hyperkalemia 912 (14.0) 448 (6.9) Hypotension 302 (4.6) 194 (3.0) Hyponatremia 82 (1.3) 47 (0.7) Heart Failure with LVEF ≥ 40% The safety of Kerendia in patients with heart failure (LVEF ≥40%) was evaluated in the randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 study, FINEARTS-HF, in which a total of 2,993 patients were treated with 10 mg, 20 mg, or 40 mg once daily of Kerendia with a mean duration of treatment of 2.3 years.
The overall safety profile of Kerendia in the FINEARTS-HF study was largely consistent with the adverse reactions reported in patients with CKD and T2DM (Table 4).
However, adverse reactions related to worsening renal function were reported more frequently in the Kerendia group (18%) compared with placebo (12%) in FINEARTS-HF.
The most frequently reported adverse reactions included renal impairment (7% vs.
4%), eGFR decreased (5% vs.
4%), acute kidney injury (4% vs.
2%) and renal failure (3% vs.
2%).
The majority of events were reported to be mild to moderate.
These events led to dose modifications in 9% of patients receiving Kerendia versus 4% of patients receiving placebo.
Hospitalization due to events related to worsening of renal function for the Kerendia group was 2.0% versus 1.3% in the placebo group.
Laboratory Test Initiation of Kerendia may cause an initial small increase in blood creatinine levels (mean change <0.1 mg/dL) and a small decrease in eGFR (mean change 2-3 ml/min) that occurs within the first 4 weeks of starting therapy and then stabilizes.
These changes were reversible after treatment discontinuation.
Initiation of Kerendia may also cause a small increase in serum uric acid.
This increase appears to attenuate over time.
6.2 Postmarketing Experience The following additional adverse reactions have been reported in postmarketing experience with finerenone.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure: Hypersensitivity: Angioedema, Rash and Urticaria
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc.
at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
CKD associated with T2DM The safety of Kerendia in patients with CKD associated with T2DM was evaluated in 2 randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 studies, FIDELIO-DKD and FIGARO-DKD, in which a total of 6510 patients were treated with 10 or 20 mg once daily over a mean duration of 2.2 and 2.9 years, respectively.
Overall, serious adverse events occurred in 32% of patients receiving Kerendia and in 34% of patients receiving placebo in the FIDELIO-DKD study; the findings were similar in the FIGARO-DKD study.
Permanent discontinuations due to adverse events also occurred in a similar proportion of patients in the two studies (6-7% of patients receiving Kerendia and in 5-6% of patients receiving placebo).
The most frequently reported (≥ 10%) adverse reaction was hyperkalemia [see Warnings and Precautions (5.1) ].
Hospitalization due to hyperkalemia for the Kerendia group was 0.9% vs 0.2% in the placebo group across both studies.
Hyperkalemia led to permanent discontinuation of treatment in 1.7% receiving Kerendia versus 0.6% of patients receiving placebo across both studies.
Table 4 shows adverse reactions that occurred more commonly on Kerendia than on placebo, and in at least 1% of patients treated with Kerendia.
Table 4: Adverse reactions reported in ≥ 1% of patients on Kerendia and more frequently than placebo (Pooled data from FIDELIO-DKD and FIGARO-DKD) Adverse reactions Kerendia N = 6510 n (%) Placebo N = 6489 n (%) Hyperkalemia 912 (14.0) 448 (6.9) Hypotension 302 (4.6) 194 (3.0) Hyponatremia 82 (1.3) 47 (0.7) Heart Failure with LVEF ≥ 40% The safety of Kerendia in patients with heart failure (LVEF ≥40%) was evaluated in the randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 study, FINEARTS-HF, in which a total of 2,993 patients were treated with 10 mg, 20 mg, or 40 mg once daily of Kerendia with a mean duration of treatment of 2.3 years.
The overall safety profile of Kerendia in the FINEARTS-HF study was largely consistent with the adverse reactions reported in patients with CKD and T2DM (Table 4).
However, adverse reactions related to worsening renal function were reported more frequently in the Kerendia group (18%) compared with placebo (12%) in FINEARTS-HF.
The most frequently reported adverse reactions included renal impairment (7% vs.
4%), eGFR decreased (5% vs.
4%), acute kidney injury (4% vs.
2%) and renal failure (3% vs.
2%).
The majority of events were reported to be mild to moderate.
These events led to dose modifications in 9% of patients receiving Kerendia versus 4% of patients receiving placebo.
Hospitalization due to events related to worsening of renal function for the Kerendia group was 2.0% versus 1.3% in the placebo group.
Laboratory Test Initiation of Kerendia may cause an initial small increase in blood creatinine levels (mean change <0.1 mg/dL) and a small decrease in eGFR (mean change 2-3 ml/min) that occurs within the first 4 weeks of starting therapy and then stabilizes.
These changes were reversible after treatment discontinuation.
Initiation of Kerendia may also cause a small increase in serum uric acid.
This increase appears to attenuate over time.
6.2 Postmarketing Experience The following additional adverse reactions have been reported in postmarketing experience with finerenone.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure: Hypersensitivity: Angioedema, Rash and Urticaria