Drug updated on 7/25/2024
| Dosage Form | Injection (intravenous; 500-1900 MBq/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) and other causes of cognitive decline. A negative Amyvid 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 Amyvid 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 older people with normal cognition. Amyvid is an adjunct to other diagnostic evaluations.
Latest News
Summary
- Florbetapir F 18 (Amyvid) 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.
- The information was derived from a total of 2 systematic reviews/meta-analyses studies reviewed, focusing on the efficacy and diagnostic performance of amyloid PET imaging using Amyvid.
- In terms of safety and effectiveness, florbetapir F 18 shows high diagnostic accuracy with pooled sensitivity at 0.90 and specificity at 0.80 for diagnosing AD; however, it has lesser specificity when distinguishing AD from mild cognitive impairment (MCI), indicating potential misdiagnosis risks.
- Subgroup analysis reveals that while florbetapir F 18 effectively differentiates between AD and normal cognition populations, its ability to distinguish MCI from AD is limited due to poor specificity in this subgroup.
- Compared to other radiotracers like [^11C]-PIB PET, no significant differences were found in overall diagnostic performance; both tracers show comparable results making them equally effective options depending on clinical settings' availability or preference.
- For those using Amyvid as an adjunctive tool in diagnosing Alzheimer's disease, it's crucial to consider multimodal approaches given its limitations in accurately predicting MCI conversion into Alzheimer's Disease.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Amyvid (Florbetapir F 18 Injection) Prescribing Information. | 2023 | Lilly USA LLC., Indianapolis, IN |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Amyloid-β PET in Alzheimer's disease: a systematic review and Bayesian meta-analysis. | 2023 | Brain and Behavior |
| 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 |