FLUTEMETAMOL F-18 (Vizamyl) Nursing Considerations

What is the generic name?

FLUTEMETAMOL F-18

What is the Trade Name for FLUTEMETAMOL F-18?

Vizamyl

What are the Indications for FLUTEMETAMOL F-18?

• 1 INDICATIONS AND USAGE Vizamyl is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate Œ≤-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. Vizamyl is an adjunct to other diagnostic evaluations. Limitations of Use: A positive Vizamyl scan does not establish a diagnosis of AD or other cognitive disorder. Safety and effectiveness of Vizamyl have not been established for: Predicting development of dementia or other neurologic condition. Monitoring responses to therapies. Vizamyl is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate Œ≤-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or 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 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. Vizamyl is an adjunct to other diagnostic evaluations ( 1 ). Limitations of Use: A positive Vizamyl scan does not establish a diagnosis of AD or other cognitive disorder ( 1 ) Safety and effectiveness of Vizamyl have not been established for: Predicting development of dementia or other neurological condition ( 1 ) Monitoring responses to therapies ( 1 )

References: https://open.fda.gov/