Amyvid received Food and Drug Administration (FDA) approval for diagnostic use in adult patients with a history of mild, moderate, or severe dementia. It aids in the diagnosis of Alzheimer's disease by visualizing beta-amyloid neuritic plaque density in the brain [1].
How does Amyvid help diagnose Alzheimer's disease?
Amyvid, also known as florbetapir F-18 injection, is a radioactive drug used as a positron emission tomography (PET) imaging agent. After intravenous injection, it binds to beta-amyloid plaques in the brain. A PET scan then detects the radioactive tracer, allowing healthcare providers to visualize the presence and density of these plaques. This information assists in the diagnostic process for Alzheimer's disease, particularly when combined with other clinical information [1].
When was Amyvid approved by the FDA?
The FDA approved Amyvid on April 7, 2012 [1].
What is the mechanism of action for Amyvid?
Amyvid binds to beta-amyloid plaques in the brain. Beta-amyloid is a protein fragment that accumulates in the brains of individuals with Alzheimer's disease. The tracer's binding allows for visualization of these plaques through PET imaging, serving as a biomarker for the disease [1].
What are the limitations of Amyvid?
Amyvid is indicated for use in adults with a history of mild, moderate, or severe dementia who are being evaluated for Alzheimer's disease. The presence of beta-amyloid plaques visualized by Amyvid is not a definitive diagnosis of Alzheimer's disease. The tracer can also be detected in individuals with other neurological disorders, such as Parkinson's disease dementia and dementia with Lewy bodies, and even in some cognitively normal individuals. Therefore, Amyvid results should be interpreted in conjunction with clinical assessment and other diagnostic evaluations [1].
What are the side effects associated with Amyvid?
The most common side effects reported in clinical trials for Amyvid included injection site pain, headache, and increased blood pressure. These side effects are generally mild and transient [1].
Who manufactures Amyvid?
Amyvid was developed and is manufactured by Eli Lilly and Company [1].