Your Health, We Care
Another NameKerendia、LuciFine、非奈利酮、可申达
IndicationsFinerenone is applicable to chronic kidney disease related to type 2 diabetes.
Reg No.07 L 0994/23
Inspection NO.
Finerenone was developed by Bayer and launched in the United States on July 9, 2021.
As the first and only drug used to treat diabetes nephropathy, fenelidone has dual protective effects on heart and kidney in DN patients.
Finerenone reduces the adverse effects of aldosterone on the kidneys and cardiovascular system by blocking its binding to its receptors.The marketing of fenelidone provides a new treatment option for patients with diabetes nephropathy.
Finerenone
Adult patients with diabetes nephropathy.
There are no available data on Kerendia use in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies have shown developmental toxicity at exposures about 4 times those expected in humans. The clinical significance of these findings is unclear.
There are no data on the presence of finerenone or its metabolite in human milk, the effects on the breastfed infant or the effects of the drug on milk production.When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the potential risk to breastfed infants from exposure to Kerendia, avoid breastfeeding during treatment and for 1 day after treatment.
The safety and efficacy of Kerendia have not been established in patients below 18 years of age.
Of the 6510 patients who received Kerendia in the FIDELIO-DKD and FIGARO-DKD studies, 55% of patients were 65 years and older, and 14% were 75 years and older. No overall differences in safety or efficacy were observed between these patients and younger patients. No dose adjustment is required.
Avoid use of Kerendia in patients with severe hepatic impairment (Child Pugh C). No dosage adjustment is recommended in patients with mild or moderate hepatic impairment (Child Pugh A or B).Consider additional serum potassium monitoring in patients with moderate hepatic impairment (Child Pugh B).
In the event of suspected overdose, immediately interrupt Kerendia treatment. The most likely manifestation of overdose is hyperkalemia. If hyperkalemia develops, standard treatment should be initiated. Finerenone is unlikely to be efficiently removed by hemodialysis given its fraction bound to plasma proteins of about 90%.
Store at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F).
Finerenone is completely absorbed after oral administration but undergoes metabolism resulting in absolute bioavailability of 44%. Finerenone Cmax was achieved between 0.5 and 1.25 hours after dosing.
来自FDA，2022.09
