適用於患有第二型糖尿病(T2D)相關的慢性腎臟病(CKD)成年病人,可降低持續性腎絲球過濾率(eGFR)下降、末期腎病(ESKD)、心血管死亡、非致命性心肌梗塞以及因心衰竭住院的風險。
Indicated for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in adult patients, to reduce the risk of sustained eGFR decline, end-stage kidney disease (ESKD), cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure.
Finerenone 是一種非類固醇的礦物性皮質素受體(MR)選擇性拮抗劑,通過阻斷MR介導的鈉再吸收和MR過度活化,減少纖維化和炎症。
Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that works by blocking MR-mediated sodium reabsorption and MR overactivation, reducing fibrosis and inflammation.
Finerenone 在口服後完全吸收,但絕對生體可用率為44%。Finerenone 主要由 CYP3A4 代謝,半衰期約為 2 至 3 小時。
Finerenone is completely absorbed after oral administration, with an absolute bioavailability of 44%. It is primarily metabolized by CYP3A4, with a terminal half-life of approximately 2 to 3 hours.
禁用於接受強效 CYP3A4 抑制劑治療的患者以及患有腎上腺功能不全的患者。
Contraindicated in patients receiving strong CYP3A4 inhibitors and those with adrenal insufficiency.
動物研究顯示 Finerenone 可能對胎兒有毒性作用。懷孕期間不建議使用,除非對母體的益處超過對胎兒的風險。
Animal studies have shown that Finerenone may have toxic effects on the fetus. It is not recommended for use during pregnancy unless the benefit to the mother outweighs the risk to the fetus.
目前尚不清楚 Finerenone 是否分泌到人乳中,使用時應謹慎。如果需要使用 Kerendia,建議停止哺乳。
It is not known whether Finerenone is excreted in human milk. Caution is advised, and if Kerendia is necessary, breastfeeding should be discontinued.
常見副作用包括高血鉀症、低血壓和低血鈉症。
Common adverse effects include hyperkalemia, hypotension, and hyponatremia.
起始劑量根據 eGFR 確定:eGFR 60 mL/min/1.73mm 時,每日一次 20 毫克;eGFR 25 至 <60 mL/min/1.73mm 時,每日一次 10 毫克。
The starting dose is determined by eGFR: 20 mg once daily if eGFR is 60 mL/min/1.73mm, and 10 mg once daily if eGFR is 25 to <60 mL/min/1.73mm.
尚未在 18 歲以下患者中確定安全性和療效。
Safety and efficacy have not been established in patients under 18 years of age.
eGFR < 25 mL/min/1.73mm 的患者不建議開始治療。持續治療期間,如果 eGFR 15 mL/min/1.73mm,可以考慮繼續 Kerendia 治療,但應依據血鉀濃度調整治療劑量。
Treatment initiation is not recommended for patients with eGFR < 25 mL/min/1.73mm. If eGFR is 15 mL/min/1.73mm during continued treatment, Kerendia may be continued with dose adjustments based on serum potassium levels.
重度肝功能不全患者 (Child-Pugh C) 應避免使用 Kerendia。對於輕度或中度肝功能不全 (Child-Pugh A 或 B) 的患者,不建議調整劑量,但應進行額外的血清鉀監測。
Kerendia should be avoided in patients with severe hepatic impairment (Child-Pugh C). No dose adjustment is recommended for patients with mild or moderate hepatic impairment (Child-Pugh A or B), but additional serum potassium monitoring is advised.