用於治療成人原發性高膽固醇血症(異合子家族性及非家族性)或混合型血脂異常,作為飲食控制的輔助療法。可與最高耐受劑量的 statin 類藥物併用,或與其他降脂療法併用於無法以最高耐受劑量 statin 達到 LDL-C 目標的患者;亦可用於對 statin 不耐受或有禁忌症的患者。
Indicated in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet. Used in combination with a statin or other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant or for whom a statin is contraindicated.小干擾核糖核酸 (siRNA) 藥物,前蛋白轉化?枯草桿菌蛋白? 9 (PCSK9) 抑制劑。
Small interfering RNA (siRNA) directed to proprotein convertase subtilisin/kexin type 9 (PCSK9).吸收:皮下注射後約 4 小時達到血漿最高濃度。分佈:主要分佈於肝臟,血漿蛋白結合率低。代謝:主要由核酸外切?降解,不經由細胞色素 P450 酵素代謝。清除:血漿半衰期約為 9 小時,約 16% 經由腎臟排泄,藥效在肝臟中可維持長達 6 個月。
Absorption: Peak plasma concentration is reached approximately 4 hours after subcutaneous administration. Distribution: Predominantly distributed to the liver with low plasma protein binding. Metabolism: Primarily degraded by nucleases and is not a substrate for cytochrome P450 enzymes. Elimination: Plasma half-life is approximately 9 hours, with 16% renal clearance, though the pharmacodynamic effect in the liver lasts for up to 6 months.對本藥品活性成分或任何賦形劑成分過敏者。
Hypersensitivity to the active substance or to any of the excipients.目前人體數據不足。基於作用機制,懷孕期間應停止使用本藥品。若發生懷孕,應立即停藥並諮詢醫師。
Limited human data available. Based on its mechanism of action, treatment should be discontinued during pregnancy. If pregnancy occurs, the drug should be stopped immediately and a physician consulted.目前尚不清楚是否會分泌至人類乳汁中。應考量哺乳對嬰兒的益處及治療對母親的益處,評估是否停止哺乳或停止治療。
It is unknown whether the drug is excreted in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.最常見的副作用為注射部位反應(如疼痛、發紅、腫脹)、關節痛、泌尿道感染、腹瀉、支氣管炎、肢體疼痛及呼吸困難。
Common side effects include injection site reactions (e.g., pain, erythema, rash), arthralgia, urinary tract infection, diarrhea, bronchitis, pain in extremity, and dyspnea.建議劑量為 284 mg,採單次皮下注射。首次給藥後,第 3 個月給予第二劑,之後每 6 個月給藥一次。應由醫護人員於腹部、上臂或大腿進行注射。
The recommended dose is 284 mg administered as a single subcutaneous injection: initially, again at 3 months, and then every 6 months thereafter. It should be administered by a healthcare professional into the abdomen, upper arm, or thigh.儲存於 2°C 至 25°C 之間,不可冷凍。藥液應為澄清且無色至淡黃色,若有變色或顯著顆粒請勿使用。
Store between 2°C to 25°C and do not freeze. The solution should be clear and colorless to pale yellow; do not use if there is discoloration or significant particulate matter present.', 'c10': '預填式注射器:每 1.5 毫升溶液含 284 毫克 inclisiran(相當於 300 毫克 inclisiran sodium)。
Pre-filled syringe: Each 1.5 mL solution contains 284 mg inclisiran (equivalent to 300 mg inclisiran sodium).', 'c11': '目前尚無 18 歲以下兒童及青少年使用的安全性和有效性數據。
The safety and efficacy in children and adolescents under the age of 18 have not yet been established.', 'c12': '輕度、中度或重度腎功能障礙患者無需調整劑量。對末期腎病患者的使用經驗有限,血液透析患者不應在透析後立即使用。
No dose adjustment is necessary in patients with mild, moderate, or severe renal impairment. Experience in patients with end-stage renal disease is limited, and hemodialysis patients should not receive the dose immediately after dialysis.', 'c13': '輕度(Child-Pugh A 級)或中度(Child-Pugh B 級)肝功能障礙患者無需調整劑量。尚未在重度肝功能障礙患者中進行研究。
No dose adjustment is necessary in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. It has not been studied in patients with severe hepatic impairment.', 'c14': '注射時應避開皮膚受損、發炎或感染區域。由於本藥效力持久,若因嚴重副作用停藥,應注意血脂濃度可能在數月內持續受壓制。
Avoid injecting into areas of active skin disease or injury. Due to the long duration of action, if the drug is discontinued due to adverse effects, be aware that LDL-C suppression may persist for several months.', 'c15': '不適用。本藥品為皮下注射液,不可口服,亦無磨粉需求。
Not applicable. This medication is a subcutaneous injection and is not intended for oral administration or crushing.