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  药店国别: 美国药房
产地国家: 美国
所属类别: 神经系统药物->阿尔兹海默症
处方药:处方药
包装规格: 2 ML/vial/box
计价单位:
  点击放大  
生产厂家中文参考译名:
卫材株式会社
生产厂家英文名:
EISAI
该药品相关信息网址1:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d1ff786-e577-410a-a273-c4d7d0e4e975
原产地英文商品名:
LEQEMBI 200 MG/2 ML/VIAL
原产地英文药品名:
Lecanemab-irmb
中文参考商品译名:
LEQEMBI 200毫克/2毫升/小瓶
中文参考药品译名:
仑卡奈单抗
原产地国家批准上市年份:
2023/01/06
英文适应病症1:
Alzheimer's disease
临床试验期:

中文适应病症参考翻译1:
阿尔兹海默症
药品信息:

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 详细处方信息以本药内容附件(20237522533627.pdf)文件为准
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部分中文 处方资料(仅供参考)



LEQEMBI是一种β淀粉样蛋白靶向抗体,用于治疗阿尔茨海默病。LEQEMBI治疗应在轻度认知障碍或轻度痴呆期疾病患者中开始,即在临床试验中开始治疗的人群。没有关于在疾病的早期或晚期开始治疗的安全性或有效性数据。该适应症在加速批准下获得批准,基于在接受 LEQEMBI 治疗的患者中观察到的淀粉样蛋白 β 斑块的减少。该适应证的持续批准可能取决于验证性试验中对临床益处的验证。




Confirm the presence of amyloid beta pathology prior to initiating treatment.The recommended dosage is 10 mg/kg that must be diluted then administered as an intravenous infusion over approximately one hour, once every two weeks.Obtain a recent (within one year) brain MRI prior to initiating treatment to evaluate for pre-existing Amyloid Related Imaging Abnormalities (ARIA).Obtain an MRI prior to the 5th, 7th, and 14th infusions. If radiographically observed ARIA occurs, treatment recommendations are based on type, severity, and presence of symptoms.Dilution in 250 mL of 0.9% Sodium Chloride Injection, USP, is required prior to administration. Administer as an intravenous infusion over approximately one hour via a terminal low-protein binding 0.2 micron in-line filter.




Advise the patient and/or caregiver to read the FDA-approved patient labeling (MEDICATION GUIDE).



Amyloid Related Imaging Abnormalities


Inform patients that LEQEMBI may cause Amyloid Related Imaging Abnormalities or “ARIA”. ARIA most commonly presents as a temporary swelling in areas of the brain that usually resolves over time. Some people may also have small spots of bleeding in or on the surface of the brain. Inform patients that most people with swelling in areas of the brain do not experience symptoms, however, some people may experience symptoms such as headache, confusion, dizziness, vision changes, nausea, aphasia, weakness, or seizure. Instruct patients to notify their healthcare provider if these symptoms occur. Inform patients that events of intracerebral hemorrhage greater than 1 cm in diameter have been reported infrequently in patients taking LEQEMBI, and that the use of antithrombotic or thrombolytic medications while taking LEQEMBI may increase the risk of bleeding in the brain. Notify patients that their healthcare provider will perform MRI scans to monitor for ARIA [see Warnings and Precautions.


Inform patients that although ARIA can occur in any patient treated with LEQEMBI, there is an increased risk in patients who are ApoE ε4 homozygotes, and that there is a test available to determine ApoE ε4 genotype.



Patient Registry


Advise patients that the Alzheimer’s Network for Treatment and Diagnostics (ALZ-NET) is a voluntary provider-enrolled patient registry that collects information on treatments for Alzheimer’s disease, including LEQEMBI. Encourage patients to participate in the ALZ-NET registry see Warnings and Precautions Infusion-Related Reactions Advise patients of the potential risk of infusion-related reactions, which can include flu-like symptoms, nausea, vomiting, and changes in blood pressure, the majority of which occur with the first infusion see Warnings and Precautions.

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 详细处方信息以本药内容附件(20237522533627.pdf)文件为准
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更新日期: 20230706
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