Neuraceq（florbetaben F18）获得美国FDA批准为第三种淀粉样蛋白造影剂，用于阿尔兹海默病患者PET成像
Neuraceq活性成分为Florbetaben F18。Flutemetamol 18是一种F18标记的1,2-二苯乙烯衍生物，能够与脑部的β-淀粉样蛋白斑结合，产生能够被PET扫描检测到的正电子信号。
Neuraceq(Florbetaben F18)是FDA批准的第三个淀粉样蛋白斑诊断试剂，之前还批准了Vizamyl (Flutemetamol F18)、Amyvid (Florbetapir F18)，Florbetaben F18与Flutemetamol F18属于同类化合物。
特点：FDA和欧盟均已批准
NEURACEQ（florbetaben 18 F注射），静脉使用
美国首次批准：2014年
作用机制
Florbetaben F18是一个F18标记的二苯乙烯衍生物，其结合β-淀粉样蛋白斑在大脑中的18 F同位素产生由PET扫描器检测出的正电子信号。3H-florbetaben体外结合实验揭示了两个结合位点（Kd值16纳米和135纳米）的额叶皮层匀浆AD患者。florbetaben F18的结合使用放射自显影相关既免疫组化和Bielschowsky银染到β淀粉样蛋白在验尸脑切片斑块AD患者。florbetaben18 F做不从患者结合tau蛋白或α突触核蛋白的组织与AD。无论Neuraceq也不是非放射性florbetaben˚F19绑定到，AT8阳性tau蛋白沉积在脑组织中，从患者的额颞叶痴呆（FTD），采用放射自显影和免疫组化分别。 
适应症和用法
Neuraceq™是放射性诊断剂表明用于正电子发射断层扫描（PET）的脑来估计β淀粉样神经炎斑密度在成人患者的认知障碍谁正在评估为阿尔茨海默氏病（AD）和认知功能减退等原因造成的成像。负Neuraceq扫描表明稀疏无神经斑，并与AD的图像采集时的病理诊断不一致;.负的扫描结果减少的可能性，患者的认知功能障碍是由于AD正Neuraceq扫描表明适度频繁淀粉样神经炎斑;.神经病理学检查表明该量的淀粉样神经炎斑的存在AD患者，但也可存在于患者的其他类型的神经系统疾病，以及老年人认知功能正常Neuraceq是一种辅助其他诊断评估。
使用限制
•正Neuraceq扫描不建立AD或其他认知障碍的诊断。
•Neuraceq的安全性和有效性尚未确定为：
•预测老年痴呆症或其他神经系统疾病发展
•监测反应疗法
用法用量
使用适当的辐射处理措施。
•管理300活度（8.1毫居里），为缓慢单次静脉内推注（6秒/毫升）在高达10毫升的总体积
•获得15-20分钟的PET图像从静脉给药后45〜130分钟算起
•图片解读：指完整处方信息
•辐射从300活度吸收剂量Neuraceq（8.1毫居里）剂量为5.8毫希沃特的成人
剂型和规格
含有50〜5000活度/ mL的强度的清晰可注射的溶液（1.4 to135居里/毫升）florbetaben F18在结束合成（EOS）。在施用300活度（8.1毫居里）时间30毫升的多剂量小瓶中包含在最多为10注射mL溶液。
禁忌
无
警告和注意事项
•图像判读错误（尤其是误判）已经观察到。
•Neuraceq，像所有的放射性药物，有助于患者的长期累积辐射暴露。确保安全处理，以保护患者和医护人员无意辐射照射。
不良反应
最常见的不良反应为：。注射部位反应有红斑（1.7％），刺激（1.2％），疼痛（3.9％）
包装规格/储存与处理
如何提供
Neuraceq在含有高达30毫升的透明溶液在50〜5000活度/ mL的强度的30毫升玻璃小瓶供给（1.4至135毫居里/毫升）florbetaben F18在EOS每管含有多个剂量和被包围在屏蔽容器，以尽量减少外照射。
存储和处理
商店Neuraceq在室温25°C（77°F）;游览允许2°C至42°C（36°F至108°F）。
NEURACEQ (florbetaben F 18 injection), for intravenous
Beta-Amyloid Plaque Estimation
Radioactive, adjunctive diagnostic agent indicated for PET brain imaging to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being eva luated for Alzheimer disease (AD) and other causes of cognitive decline
A negative scan indicates sparse-to-no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD as a cause of cognitive impairment, whereas a positive scan indicates moderate-to-frequent amyloid neuritic plaques
Moderate-to-frequent amyloid plagues are found in patients with AD but may also be present in those with other types of neurologic conditions, as well as in older people with normal cognition
Dosage
300 megabecquerels (MBq), ie, 8.1 millicuries (mCi) IV bolus administered by slow IV bolus (1 mL/6 seconds) in a total volume of up to 10 mL
Follow injection with an IV flush of 10 mL of 0.9% NaCl
Image Display & Interpretation
A 15 to 20-minute PET image should be acquired starting 45-130 minutes after IV injection
The patient should be supine; position head to center the brain, including the cerebellum, in the PET scanner field of view
Reduce head movement with tape, or other flexible head restraints may be used
Display
Display images in the transaxial orientation using gray scale or inverse gray scale
Sagittal and coronal planes may be used for additional orientation purposes
CT or MR images may be helpful for anatomic reference purposes; however, visual assessment should be performed using the axial planes according to the recommended reading methodology
Interpretation
Visually compare the activity in cortical gray matter with activity in adjacent white matter Regions displayed in the PET images which ‘anatomically’ correspond to white matter structures (eg, the cerebellar white matter or the splenium) should be identified to help the readers orient themselves
View and assess images in a systematic manner, starting with the cerebellum and scrolling up through the lateral temporal and frontal lobes, the posterior cingulate cortex/precuneus, and the parietal lobes
For a gray matter cortical region to be assessed as showing "tracer uptake" the majority of slices from the respective region must be affected
For each patient, the PET image assessment is categorized as either beta-amyloid-positive or beta-amyloid-negative
Beta-amyloid negative: Tracer uptake (ie, signal intensity) in gray matter is lower than in white matter in all 4 brain regions (no beta-amyloid deposition)
Beta-amyloid positive: Smaller area(s) of tracer uptake equal to or higher than that present in white matter extending beyond the white matter rim to the outer cortical margin involving the majority of the slices within at least 1 of the 4 brain regions (moderate beta-amyloid deposition), or a large confluent area of tracer uptake equal to or higher than that present in white matter extending beyond the white matter rim to the outer cortical margin and involving the entire region, including the majority of slices within at least 1 of the 4 brain regions (pronounced beta-amyloid deposition)
See figures of PET images in the prescribing information for further information
Not indicated
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b0915068-cfd4-4d72-b9f8-7e31fe83cd1e