2012年4月10日，美国食品与药物管理局（FDA）批准了Florbetapir F 18注射剂（Amyvid），作为正电子发射断层摄影术（PET）的造影剂，用于阿尔茨海默病（AD）成人和其他认知下降患者β-淀粉样神经斑的显像。
AMYVID，是一种分子显影剂，患者注射后进行PET扫描，用于检测患者脑内的β-淀粉样蛋白斑块。β-淀粉样蛋白是阿尔茨海默病发生的主要病理产物。本品为阿尔茨海默氏病(AD)和其他原因认知下降患者放射性诊断药。
研究专家表示，若是能够及早发现患者体内的淀粉样斑块，那么医师就可及时诊断出阿尔茨海默症，有利于进一步治疗。
Amyvid(Florbetapir F 18注射液)为静脉使用
批准日期：2012年4月10日；公司：AVID RADIOPHARMS INC

美国初始批准：2012
一般描述
Amyvid含florbetapir F 18，一种分子影像剂与β-淀粉样集聚结合，和意向为PET脑影像使用。化学上，florbetapir F 18被描述为(E)-4-(2-(6-(2-(2-(2[18F] fluoroethoxy)ethoxy)ethoxy)pyridine3-yl)vinyl)-N-methylbenzamine. 分子量359和结构式为：

Amyvid是一种无菌，无防腐剂为静脉注射放射性诊断剂。以澄明，无色溶液提供备用和每mL含0.1至19 mg的florbetapir和500 - 1900 MBq (13.5 - 51 mCi) florbetapir F 18在EOS，4.5 mg溶液抗坏血酸USP和0.1 mL 无水酒精USP在0.9%氯化钠注射液中USP。溶液的pH在5.5和7.5间。
作用机制
Florbetapir F 18与β-淀粉样斑块结合和F 18同位素产生一个正电子信号被一台PET扫描仪检测到。在体外用人死后尸检含β-淀粉样斑块脑匀浆结合研究，florbetapir的解离常数(Kd)为3.7 ± 0.3 nM。死后尸检人脑切片用放射自显影方法，硫黄素[thioflavin]S和传统银染色相关研究以及单克隆抗体β-淀粉样-特异性相关研究证实F 18与β-淀粉样集聚的结合。Florbetapir结合至tau蛋白和在体外研究中未检测到一组神经受体。 
适应证和用途
Amyvid是一种放射性诊断剂，适用为有认知障碍成年正在评价为阿尔茨海默氏病(AD)和其他原因认知下降患者中为脑正电子发射断层扫描(PET)影像估计β-淀粉样神经炎斑块密度。一个阴性Amyvid扫描表明稀少至无神经性斑块，和影像获得时AD的神经病理学诊断不一致；一个阴性扫描结果减低患者认知障碍是由于AD的可能性。一个阳性Amyvid扫描表明中度至频繁淀粉样神经炎斑块；神经病理学检查已证实AD患者中存在淀粉样神经炎斑块的这个量，但有其他类型神经学情况患者以及有正常认知老年人也可能存在。Amyvid是对其他诊断评价的辅助(1)。
使用的限制
（1）一个阳性Amyvid扫描不能确定AD或其他认知疾病的诊断(1)。
（2）尚未确定Amyvid的安全性和有效性：
1）预测痴呆或其他神经学情况的发展；
2）监测对治疗的反应 (1).
剂量和给药方法
用适当辐射安全性处置测量(2.1).
（1）给予370 MBq (10 mCi)作为单次静脉推注总体积10 mL或以下(2.2).
（2）静脉注射后约30至50分钟开始得到10-分钟PET影像(2.3).
（3）影像解释：参阅完整处方资料(2.4).
（4）成年人来自370 MBq(10 mCi)剂量Amyvid辐射吸收剂量为7 mSv(2.5).
剂型和规格
10 mL，30 mL，或50 mL多剂量小瓶含透明，无色可注射溶液在合成终止时(EOS)辐射强度500-1900 MBq/mL(13.5-51 mCi/mL) florbetapir F 18 (3).
禁忌证
无 (4).
警告和注意事项
（1）曾观察到影像解释错误(特别是)(5.1).
（2）辐射风险：Amyvid，与所有放射性药物相似，对患者长期累积辐射暴露。确保安全处置保护患者和卫生保健工作者避免无意辐射暴露(2.1，5.2).
不良反应
最常报道不良反应是：头痛(2%)，肌肉骨骼痛(1%)，疲乏(1%)，和恶心(1%) (6).
为报告怀疑不良反应，联系Eli Lilly公司电话1-800-LillyRx (1-800-545-5979)或FDA电话1-800-FDA-1088或www.fda.gov/medwatch

Amyvid Brain Scan
Amyloid PET Scan for Alzheimer's Disease
The Amyvid scan is an important advancement in the detection of Alzheimer's disease. Amyvid (Florbetapir F 18 Injection) is a drug for Positron Emission Tomography (PET) imaging of the brain in adults who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline. Cognitive decline is a condition where the capability to think and form clear, coherent thoughts and choices has decreased. AD is one form of dementia that gradually worsens over time. It affects memory, thinking, and behavior.
Amyvid is the first-and-only FDA-approved diagnostic PET tracer available. “Many Americans undergo evaluations to try to determine the cause for a decline in cognitive functioning,” says Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research.  “Until now, the brain content of β-amyloid neuritic plaques could only be determined with a brain biopsy or examination of the brain at autopsy.  This imaging agent is one tool to help physicians in the assessment of their patients by serving as an adjunct to other diagnostic evaluations.”
After receiving an intravenous injection, Amyvid (a radioactive drug) binds to brain β-amyloid.  β-amyloid protein is a type of protein that forms in patients with AD and some other cognitive disorders. Neuritic plaques, also called amyloid plaques, are abnormal clumps of brain cells mixed with β-amyloid protein. This radioactive signal can then be detected with a PET scanner which produces images of the plaque in the brain. A positive Amyvid scan indicates moderate to frequent plaques.  However, a positive Amyvid scan does not establish a diagnosis of AD because, although patients with AD always have an increased brain content of plaque, the test also may be positive in patients with other types of neurologic conditions, as well as in older people with normal cognition.
A negative Amyvid scan indicates light to no neuritic plaques; a negative scan outcome lessens the likelihood that a patient’s cognitive impairment is due to AD. Amyvid is used in addition to other diagnostic evaluations.
The Amyvid scan is quick – the patient is in and out within an hour:
No fasting required.
No change to your daily medications – take all your medications as usual.
After the injection, there is a 30-50 minute uptake time to allow the medication to bind in the brain.
The actual scan only takes about 10 minutes.