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Kerendia®▼ (finerenone) Prescribing Considerations
Please refer to the SmPC for full information on Kerendia prescribing considerations
See Dosing section for information on treatment initiation, continuation & dose adjustment according to serum potassium & eGFR
- hypersensitivity to the active substance or to any of the excipients*
- concomitant treatment with strong inhibitors of CYP3A4
- Addison’s disease
Hyperkalaemia has been observed in patients treated with finerenone.
Patients at a higher risk of developing hyperkalaemia include those with:
- low eGFR
- higher serum potassium
- previous episodes of hyperkalaemia
In these patients more frequent monitoring has to be considered
Kerendia should not be used with(see also Contraindications):
- strong or moderate CYP3A4 inducers
- potassium-sparing diuretics and other mineralocorticoid receptor antagonists
- grapefruit or grapefruit juice
Kerendia should be used with caution and additional serum potassium monitoring and adaptation of monitoring according to patient characteristics should be considered in patients taking concomitant:
- moderate or weak CYP3A4 inhibitors
- potassium supplements
- trimethoprim, or trimethoprim/sulfamethoxazole (temporary discontinuation of Kerendia may be necessary while on trimethoprim or trimethoprim/sulfamethoxazole treatments)
In these patients, more frequent monitoring has to be considered.
This risk for hypotension increases with concomitant use of multiple other antihypertensive medicinal products.
† Includes medicines or substances that may affect Kerendia exposure or that may increase the risk of hyperkalaemia
There are no data for the use of Kerendia in pregnant women.
Kerendia should not be used with:
- Kerendia should not be used during pregnancy unless there has been careful consideration of the benefit for the mother and the risk to the foetus
- If a woman becomes pregnant while taking Kerendia, she should be informed of potential risks to the foetus
- Women should be advised not to breast-feed during treatment with Kerendia
- Women of childbearing potential should use effective contraception during Kerendia treatment.
* Kerendia contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product
Hepatic impairment
Severe: Kerendia treatment should not be initiated
These patients have not been studied but a significant increase in Kerendia exposure is expected
Moderate: no initial dose adjustment is required, consider additional serum potassium monitoring and adapt monitoring according to patient characteristics
Mild: no initial dose adjustment is required
Renal impairment
The risk of hyperkalaemia increases with decreasing renal function. Ongoing monitoring of renal function should be performed as needed according to standard practice.
Hyperkalaemia
Patients with a higher risk of developing hyperkalaemia and therefore may require more frequent monitoring are those with:
- low eGFR‡
- higher serum potassium
- previous episodes of hyperkalaemia
Four weeks after initiation or re-start of treatment with Kerendia or an increase in dose, serum potassium and eGFR needs to be remeasured in all patients. Thereafter, serum potassium has to be assessed periodically and as needed based on patient characteristics and serum potassium levels.
Taking Kerendia concomitantly with other medicines or substances may increase the risk of hyperkalaemia and/or affect Kerendia exposure. Please see additional information on concomitant use of medicines and substances with Kerendia here.
‡ The risk of hyperkalaemia increases with decreasing renal function. Ongoing monitoring of renal function should be performed as needed according to standard practice
Body Weight
No dose adjustment is necessary based on body weight.
Paediatric population
The safety and efficacy of finerenone in children and adolescents aged under 18 years have not yet been established. No data are available.
eGFR=estimated glomerular filtration rate; MOD=mechanism of disease; MOA=mechanism of action.
PP-KER-GB-0474 | March 2024
- Referencesexpand_more
- 1GB Kerendia SmPC, NI Kerendia SmPC