Kerendia
Authorised
This medicine is authorised for use in the European Union
finerenone
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Kerendia is a medicine used to treat chronic kidney disease in adults with type 2 diabetes.
It is used for patients with moderate or severe kidney damage who pass albumin (a type of protein) in their urine.
Kerendia contains the active substance finerenone.
Kerendia can only be obtained with a prescription.
Kerendia is available as tablets to be taken by mouth once a day. The dosage to be taken depends on the patient’s kidney function.
For more information about using Kerendia, see the package leaflet or contact your doctor or pharmacist.
The active substance in Kerendia, finerenone, binds to a receptor (target) known as mineralocorticoid receptor (MR). MR is involved in the activation of processes that cause inflammation and scarring in the kidneys. By binding to MR, Kerendia blocks the start of these processes, preventing inflammation and scarring and leading to less kidney damage.
Kerendia, in addition to standard treatment, was shown to be effective at slowing down kidney disease in one main study involving over 5,600 patients with chronic kidney disease and type 2 diabetes. In this study, 18% of patients taking Kerendia (504 out of 2,833) experienced a loss of kidney function compared with 21% of patients taking a placebo, or dummy treatment, (600 out of 2,841).
The most common side effect with Kerendia (which may affect more than 1 in 10 people) is the presence of high potassium levels in the blood. Other common side effects, which may affect up to 1 in 10 people, are low levels of sodium in the blood, low blood pressure, itching and loss of kidney function.
Kerendia must not be used in patients with Addison’s disease (a condition that prevents the body from producing enough of the hormones cortisol and aldosterone). It must also not be used with certain medicines that strongly block the effects of CYP3A4, a liver enzyme that helps the body process many medicines.
For the full list of side effects and restrictions of Kerendia, see the package leaflet.
Kerendia was shown to slow down loss of kidney function in adults with chronic kidney disease and type 2 diabetes. Overall, the medicine’s side effects were considered manageable. Therefore, the European Medicines Agency decided that Kerendia’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kerendia have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Kerendia are continuously monitored. Side effects reported with Kerendia are carefully evaluated and any necessary action taken to protect patients.
Kerendia received a marketing authorisation valid throughout the EU on 16 February 2022.
Product information
Latest procedure affecting product information:
N/0009
16/09/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Kerendia
- Active substance
- Finerenone
- International non-proprietary name (INN) or common name
- finerenone
- Therapeutic area (MeSH)
- Renal Insufficiency, Chronic
- Diabetes Mellitus, Type 2
- Anatomical therapeutic chemical (ATC) code
- C09
Pharmacotherapeutic group
Agents acting on the renin-angiotensin systemTherapeutic indication
Kerendia is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.
News on Kerendia
This page was last updated on