Drug updated on 4/24/2024
| Dosage Form | Injection (intravenous; 150 MBq/mL (4.05 mCi/mL) |
| Drug Class | Radioactive diagnostic agents |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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) 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.
Summary
- Flutemetamol F 18 (Vizamyl) is utilized 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 or other causes of cognitive decline. Its effectiveness and safety have also been reviewed in the context of Transthyretin amyloid cardiomyopathy.
- The information originated from one systematic review/meta-analysis that included data up until December 2022 and covered 21 studies with a total of 211 Transthyretin amyloidosis patients.
- In diagnosing Transthyretin amyloid cardiomyopathy, Vizamyl's performance compared to other PET tracers like carbon-11 Pittsburgh compound B ([11C]PIB), fluorine-18 Florbetaben ([18F]FBB), fluorine-18 Florbetapir ([18F]FBP), and fluorine-18 Sodium Fluoride (Na[18F]F) remains unclear due to contradictory evidence suggesting variability in effectiveness or potential limitations.
- The study does not explicitly detail comparative safety information but generally regards PET tracers, including Vizamyl, as carrying risks such as reactions at the injection site, potential allergic reactions, or adverse effects related to the radiotracer substance itself.
- The review specifically considers patients with ATTR amyloid cardiomyopathy, highlighting diagnostic challenges and the necessity for accurate differentiation between various forms of amyloidoses and cardiomyopathies; however, it does not provide detailed subgroup analyses beyond this distinction.
- Vizamyl's utility in diagnosing or assessing ATTR Amyloid Cardiomyopathy, compared to its primary indication - the evaluation for Alzheimer’s disease - necessitates additional research based on findings from this systematic review/meta-analysis.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Vizamyl (flutemetamol F 18) Prescribing Information. | 2020 | GE Healthcare, Medi-Physics, Inc., Arlington Heights, IL |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Positron emission tomography in the diagnosis and follow-up of transthyretin amyloid cardiomyopathy patients: a systematic review. | 2023 | European Journal of Nuclear Medicine and Molecular Imaging |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| International Nuclear Medicine Consensus on the Clinical Use of Amyloid Positron Emission Tomography in Alzheimer’s Disease. | 2022 | Phenomics |