Kerendia®▼ (finerenone) Safety Profile

For safety-related prescribing considerations please refer to the prescribing considerations tab in the navigation pane and please refer to the SmPC for detailed information.

FIDELIO-DKD was a randomised, double blind, placebo-controlled multicentre trial that included 5658 patients with CKD and T2D, the primary outcome was kidney failure, (Kidney failure was defined as end stage kidney disease i.e. initiation of long-term dialysis for ≥ 90 days or kidney transplantation) or an eGFR of <15mls/min/1.73m²​, a sustained decrease of at least 40% in the eGFR from baseline, or death from renal causes.

Please refer to section 4.8 of the Summary of Product Characteristics for further information on undesirable effects

†Shown are adverse events that occurred during the treatment period, defined as those that started or worsened during finerenone or placebo intake or up to 3 days after any temporary or permanent interruption. A casual relationship between any adverse event and administration of finerenone or placebo was based on the opinion of the reporting investigator.

*An adverse event was considered to be a serious adverse event if it resulted in death, was life threatening, resulted in inpatient hospitalisation (or prolongation of existing hospitalisation), caused persistent or clinically significant disability or incapacity, was a congenital abnormality or birth defect, or was judged by the investigator to be a serious or important medical event.

Investigator-reported renal AEs

Adapted from Bakris

^*These events were classified according to the MedDRA preferred term.

^†These events were classified according to the standardised MedDRA Query term.

Kerendia Safety Profile:

Kerendia was associated with hyperkalaemia

As reflected in the placebo arm, patients in FIDELIO-DKD had an intrinsic risk of hyperkalaemia because of their advanced CKD, T2D, and treatment with optimised doses of an ACEi or ARB

In patients treated with finerenone, the majority of hyperkalaemia events were mild to moderate and resolved. Serious events of hyperkalaemia were reported more frequently for finerenone (1.6%) than for placebo (0.4%).

Patients treated with finerenone are at higher risk to develop hyperkalaemia. Risk factors include low eGFR, higher serum potassium and previous episodes of hyperkalaemia. In these patients more frequent monitoring has to be considered. Please consult the product SmPC for further information on hyperkalaemia and its management.

Adapted from Bakris

*Investigator-reported AEs using the MedDRA preferred terms ‘hyperkalaemia’ & ‘blood potassium increased’ AE, adverse event;

Adapted from Bakris

Effects on serum potassium over time in the safety analysis set

Maximum mean difference in potassium between groups was 0.23 mmol/L (SD ± 0.5) at Month 4*, remaining stable thereafter

Adapted from Bakris

*based on a mean change of 0.25mmol/L in the finerenone group and 0.02 mmol/L in the placebo group.

In the FIDELIO DKD trial, management of hyperkalaemia was at the investigators discretion.

• There were no restrictions on the use of potassium supplements or potassium binders during the trial and a low-potassium diet was not mandated by the protocol

Concomitant use of Kerendia with potassium supplements and medications that may increase serum potassium is anticipated to increase the risk of hyperkalaemia. Monitoring of serum potassium is required. Please refer to the prescribing considerations tab or consult the SmPC for more information.

Adapted from Bakris

*Such as sodium polystyrene sulfonate, calcium polystyrene sulfonate, patiromer, sodium zirconium cyclosilicate

Kerendia Safety Profile:

In keeping with its non-steroidal structure, hormonal adverse events (reproductive system and breast disorders) with Kerendia were similar to placebo

Adapted from Bakris

Kerendia Safety Profile:

Kerendia had a modest effect on SBP over time

Mean SBP over time in the safety analysis set

Adapted from Bakris

In the FIDELIO-DKD study, hypotension events were reported in 4.8% of finerenone-treated patients compared with 3.4% of placebo-treated patients. In patients treated with finerenone, the majority of hypotension events were mild or moderate and resolved. In one patient (<0.1%), finerenone treatment was permanently discontinued due to hypotension. Hospitalisation due to hypotension in the finerenone group was 0.2% versus 0.2% in the placebo group.

In patients treated with finerenone, the mean systolic blood pressure decreased by 2-4 mm Hg and the mean diastolic blood pressure decreased by 1-2 mm Hg at month 1, remaining stable thereafter.

Kerendia Safety Profile:

Kerendia had no clinically meaningful effect on HbA1c over time

Mean HbA1c (%) over time in the safety analysis set

Adapted from Bakris

AE=adverse event; ACEi=angiotensin converting enzyme inhibitor; ARB=angiotensin receptor blocker; CKD=chronic kidney disease; CVD=cardiovascular disease; DBP=diastolic blood pressure; DKD=diabetic kidney disease; HbA1c; glycated haemoglobin; MOD=mechanism of disease; MOA=mechanism of action; SBP=systolic blood pressure; SD=standard deviation; T2D=type 2 diabetes.