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 (AD) and other causes of cognitive decline.
A negative Vizamyl 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 Vizamyl 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 in older people with normal cognition.
MECHANISM OF ACTION
Flutemetamol F 18 binds to β-amyloid plaques in the brain and the F-18 isotope produces a positron signal that is detected by a PET scanner.
In in vitro binding studies using postmortem human brain homogenates containing fibrillar β-amyloid, the dissociation constant (Kd) for flutemetamol was 6.7 nM. Selectivity of [3H]flutemetamol binding in post-mortem human brain sections was demonstrated using autoradiography, silver-stained protein, and immunohistochemistry (monoclonal antibody to β-amyloid) correlation studies.
- Vizamyl is the only amyloid imaging agent with FDA approval for color image interpretation
- As an adjunct to clinical workup, Vizamyl can be effective in ruling out AD, helping to more quickly determine the appropriate clinical path for your patient
Image interpretation is based upon the distribution of radioactive signal within the brain; clinical information is not a component of image assessment.
Images are designated as positive or negative either by comparing radioactivity in cortical grey matter with activity in adjacent white matter, or based on the intensity in the five regions mentioned above. Negative scans show more radioactivity in white matter than in grey matter, creating clear grey-white matter contrast.
PATIENT COUNSELING INFORMATION
Please inform your healthcare provider if you:
- are pregnant or breast feeding, or
- have had prior reactions to Vizamyl or any component, including polysorbate 80, or
- have reduced renal or hepatic function
Please increase your level of hydration before and after receiving Vizamyl (Flutemetamol F 18 Injection) and to void frequently for the first 24 hours following Vizamyl administration.