Florbetapir F18（Amyvid）-FDA批准脑中淀粉样蛋白斑成像药物

2012年4月10日，美国FDA宣布批准Florbetapir F18注射剂（Amyvid）用于疑似患阿尔兹海默病（AD）或其他认知衰退疾病的成人患者的大脑PET照影。认知衰退是指个人无法正常思考、形成清晰理性的思考，决定能力受到限制的情况。它会使患者失去与现实、自身、他人和外部事件和环境的接触能力，

Amyvid用于PET扫描来估计认知受损患者脑中的β-淀粉状蛋白神经斑密度。阿尔兹海默病和其他认知障碍患者体内会形成β-淀粉状蛋白。淀粉样蛋白神经斑是脑中与β-淀粉状蛋白混合在一起的细胞。Amyvid扫描的阴性结果表示神经斑的数量几乎无，将降低由阿尔兹海默病引起的其他认知损害的可能性。阳性结果表示神经斑数量中度或者较多。这通常可见于阿尔兹海默病患者、其他认知受损患者，或认知正常的个别老年人。

FDA新药评价和研发中心的主任Janet Woodcock表示，为确定认知功能下降的原因，很多美国人接受了评估测试，但目前脑中的β-淀粉状蛋白神经斑水平只能通过大脑活组织检查或者在尸检时获得。本造影剂可以作为一种辅助方法帮助医师对病人进行诊断，

静脉注射后，放射性药物Amyvid将与大脑β-淀粉状蛋白结合，PET扫描仪探测到放射性信号后会产生脑部神经斑成像。阳性结果显示蛋白斑数量中度或较多，但不能因此作为AD诊断标准。

Amyvid测试未计划用于预测AD相关性痴呆的发展情况或者用于监测患者对于AD治疗的反应。Amyvid不能代替其他评价认知受损的诊断测试。这项新的核药测试的进行和影像解释只能由经过公司的专项培训后的医师来完成。Amyvid 的说明书中含有PET图像解释的信息。

常见的不良反应包括头疼、肌肉骨骼痛、疲劳和恶心。安全风险包含放射性风险和图像误读风险。

Amyvid 是由礼来公司旗下Avid Radiopharmaceutical公司生产的，Avid Radiopharmaceutical公司位于美国费城。

WARNINGS AND PRECAUTIONS
Risk for Image Misinterpretation and Other Errors
Errors may occur in the Amyvid estimation of brain neuritic plaque density during image interpretation.
Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Amyvid images has not been evaluated and may lead to errors. Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the Amyvid scan as well as motion artifacts that distort the image.
Amyvid scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in thefuture.
Radiation Risk
Amyvid, similar to other radiopharmaceuticals, contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.
MOST COMMON ADVERSE REACTIONS
The most common adverse reactions reported in clinical trials were headache (1.8%), musculoskeletal pain (0.8%), fatigue (0.6%), nausea (0.6%), anxiety (0.4%), back pain (0.4%), blood pressure increased (0.4%), claustrophobia (0.4%), feeling cold (0.4%), insomnia (0.4%), neck pain (0.4%)
DRUG INTERACTIONS
Pharmacodynamic drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Amyvid image results.
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INDICATIONS AND USAGE:
Amyvid™ (Florbetapir F 18 Injection) is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline.

A negative Amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Amyvid is an adjunct to other diagnostic evaluations.

Limitations of Use:
A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder
Safety and effectiveness of Amyvid have not been
established for:
Predicting development of dementia or other
neurologic condition
Monitoring responses to therapies
Amyvid for intravenous use is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing 500-1900 MBq/mL Florbetapir F 18.
Please see Full Prescribing Information for Amyvid. »