Amyvid ( Florbetapir F 18 Injection ) has received marketing authorization from the European Commission as a diagnostic radiopharmaceutical indicated for Positron Emission Tomography ( PET ) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation.
Alzheimer's disease is one of many possible causes of cognitive impairment, which can make diagnosis challenging. Alzheimer's disease and other causes of cognitive impairment share many overlapping symptoms, including deficiencies in memory, visuospatial ability, executive function, behavior, and language. It is estimated that up to one in five patients clinically diagnosed with probable Alzheimer's disease during life do not exhibit Alzheimer's disease pathology upon autopsy.
Amyvid for intravenous use was approved by the FDA ( Food and Drug Administration ) in April 2012 and is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing 500-1,900 MBq/mL Florbetapir F 18.
Amyvid is indicated for PET imaging of the brain to estimate beta-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 Alzheimer's disease at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to Alzheimer's disease.
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 Alzheimer's disease, 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. A positive Amyvid scan does not establish a diagnosis of Alzheimer's disease or other cognitive disorder. Safety and effectiveness of Amyvid have not been established for predicting development of dementia or other neurologic condition, or monitoring responses to therapies.
Amyvid is a radioactive diagnostic agent that is injected into the bloodstream, where it crosses the blood-brain barrier and selectively binds to amyloid plaques. The fluorine 18 ( F 18 ) isotope produces a positron signal, which is detected by a PET scanner.
Amyvid, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.
The most common adverse reactions reported in clinical trials were headache ( 1.8% ), musculoskeletal pain ( 0.8% ), fatigue ( 0.6% ), nausea ( 0.6% ). ( Xagena )
Source: Lilly, 2013