Flutemetamol F 18

(Vizamyl®)

Vizamyl®

Drug updated on 10/25/2024

Dosage FormInjection (intravenous; 150 MBq/mL (4.05 mCi/mL)
Drug ClassRadioactive 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.

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Summary
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  • 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 TitleYearSource
Vizamyl (flutemetamol F 18) Prescribing Information.2020GE Healthcare, Medi-Physics, Inc., Arlington Heights, IL

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Positron emission tomography in the diagnosis and follow-up of transthyretin amyloid cardiomyopathy patients: a systematic review.2023European Journal of Nuclear Medicine and Molecular Imaging

Clinical Practice Guidelines