Drug updated on 10/25/2024
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.
Latest News
Summary
- Vizamyl (flutemetamol F 18) is indicated for PET imaging of the brain to estimate β-amyloid neuritic plaque density in adults with cognitive impairment being evaluated for Alzheimer’s disease or other causes of cognitive decline. A negative scan suggests sparse to no neuritic plaques, reducing the likelihood of Alzheimer’s disease as the cause of cognitive impairment. A positive scan indicates moderate to frequent neuritic plaques, which are associated with Alzheimer’s disease but may also be present in other neurological conditions or in older individuals with normal cognition.
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- FMM (Flutemetamol F 18) showed inconsistent diagnostic effectiveness compared to other tracers such as [11C]PIB and Na[18F]F, which were more consistently effective in distinguishing ATTR amyloidosis and ATTR-CM from controls and from cardiac light chain amyloidosis.
- When evaluated alone, [18F]FMM's effectiveness in diagnosing ATTR amyloidosis was not consistently supported, with varying results reported across different studies.
- There is no safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
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 |