Generic Name and Formulations:
Florbetapir F 18 [500-1900MBq/mL (13.5-51mCi/mL) at End of Synthesis (EOS)]; soln for IV inj.
Lilly, Eli and Company
Indications for AMYVID:
For PET imaging of the brain to estimate β-amyloid neuritic plaque density in adults with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. As 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 efficacy not established for predicting development of dementia or other neurologic conditions; or for monitoring responses to therapies.
See full labeling. Give 370MBq (10mCi), max 50μg mass dose, as a single IV bolus dose in a total volume of ≤10mL, then follow with a sterile NaCl 0.9% IV flush. Starting 30–50mins after IV inj, acquire a 10-min PET image. The radiation absorbed dose from 370MBq (10mCi) dose is 7mSv.
Risk of radiation exposure. Should only be used by trained and experienced physicians in the safe use and handling of radioactive materials to minimize radiation exposure. Risk of image misinterpretation and other errors. Perform image interpretation independently of patient's clinical information. Pregnancy (Cat.C.); assess status in females of reproductive potential prior to therapy. Nursing mothers: not recommended, or temporarily interrupt for 24hrs after Amyvid exposure.
Radioactive diagnostic agent.
Headache, musculoskeletal pain, increased BP, nausea, fatigue, inj site reactions.
Multi-dose vials (10mL, 30mL, 50mL)—1