Drug updated on 4/15/2024
| 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.
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 and other causes of cognitive decline.
- Two studies were analyzed, focusing on the use of Florbetapir F 18 in PET imaging, particularly its application in diagnosing diseases with significant amyloid involvement such as Alzheimer's Disease and Amyloid Cardiomyopathy.
- In terms of diagnostic efficacy, Florbetapir F 18 demonstrates strong overall performance in diagnosing Alzheimer's Disease. However, it has limited specificity for distinguishing Alzheimer's Disease from mild cognitive impairment, indicating a potential challenge in early diagnosis.
- For ATTR amyloid cardiomyopathy, although Florbetapir F 18 can assist in diagnosing the presence of disease, it does not offer the specificity needed for distinguishing between different types of amyloidoses as effectively as other tracers might.
- The safety profile was generally associated with radiation exposure and potential allergic reactions, which are usually well tolerated across different agents.
- The studies covered a broad range of patients, including those with Alzheimer's Disease, MCI, and ATTR amyloidosis, providing insights into its utility across various stages. However, subgroup analysis highlighted variances based on stage, underscoring the importance of a multi-modal approach for a more accurate characterization and progression tracking.
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 |