Brand Name

Amyvid

Generic Name
Florbetapir
View Brand Information
FDA approval date: June 01, 2012
Classification: Radioactive Diagnostic Agent
Form: Injection

What is Amyvid (Florbetapir)?

Amyvid is indicated for Positron Emission Tomography 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. 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. Amyvid is a radioactive diagnostic agent for Positron Emission Tomography 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. 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 . Limitations of Use A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder . Safety and effectiveness of Amyvid have not been established for: Predicting development of dementia or other neurologic condition; Monitoring responses to therapies . Limitations of Use: A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder. Safety and effectiveness of Amyvid have not been established for: Predicting development of dementia or other neurologic condition; Monitoring responses to therapies.
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Brand Information

Amyvid (Florbetapir F 18)
1INDICATIONS AND USAGE
AMYVID is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for:
  • Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline
  • Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products
2DOSAGE FORMS AND STRENGTHS
Injection: 500 MBq/mL to 1,900 MBq/mL (13.5 mCi/mL to 51 mCi/mL) of florbetapir F 18 in up to 100 mL volume at end of synthesis (EOS) as a clear, colorless solution in a multiple-dose vial.
3CONTRAINDICATIONS
None.
4OVERDOSAGE
In the event of administration of a radiation overdose with AMYVID, hydration and frequent urination should be encouraged to minimize radiation exposure to the patient.