Vizamyl (Flutemetamol F 18 Injection)
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: Known hypersensitivity to Vizamyl or any excipient, including polysorbate 80.
Please see Product Indications and Additional Important Safety Information About Vizamyl at the bottom of this page.
Prior to Vizamyl administration, please read the Full Prescribing Information.
For more information about Vizamyl, including efficacy and safety, please visit the Vizamyl Brand Website.
For the visualization of β-amyloid neuritic plaque density in patients being evaluated for cognitive disorders, including Alzheimer's disease...Introducing the first-and-only amyloid imaging agent with FDA approval for color image interpretation.
Vizamyl is indicated for positron-emission tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline.1
- A negative Vizamyl scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of Alzheimer's disease at the time of image acquisition
- A negative scan reduces the likelihood that a patient's cognitive impairment is due to Alzheimer's disease
- A positive Vizamyl scan indicates moderate to frequent amyloid neuritic plaques
- Neuropathological examination has shown that this amount of amyloid neuritic plaque is present in patients with Alzheimer's disease, but it may also be present in patients with other types of neurologic conditions as well as in older people with normal cognition
- Vizamyl is an adjunct to other diagnostic evaluations
Limitations of Use
- A positive scan does not establish a diagnosis of Alzheimer's disease or other cognitive disorders
- Safety and effectiveness of Vizamyl have not been established for:
- Predicting development of dementia or other neurologic conditions
- Monitoring responses to therapies
1. Vizamyl [prescribing information]. Arlington Heights, IL: GE Healthcare; 2017.