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Amyvid Generic Name & Formulations
Legal Class
Rx
General Description
Florbetapir F 18 (500–1900MBq/mL [13.5–51mCi/mL] at End of Synthesis [EOS]); soln for IV inj.
Pharmacological Class
Radioactive diagnostic agent.
How Supplied
Multi-dose vials (10mL, 30mL, 50mL)—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Florbetapir F 18 binds to β-amyloid plaques and the F 18 isotope produces a positron signal that is detected by a PET scanner.
Amyvid Indications
Indications
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.
Amyvid Dosage and Administration
Adult
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.
Children
Not established.
Amyvid Contraindications
Not Applicable
Amyvid Boxed Warnings
Not Applicable
Amyvid Warnings/Precautions
Warnings/Precautions
Risk for 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 for image misinterpretation and other errors. Perform image interpretation independently of patient's clinical information. Pregnancy: assess status in females of reproductive potential prior to initiation. Nursing mothers: not recommended, or temporarily interrupt for 24hrs after Amyvid exposure.
Amyvid Pharmacokinetics
Elimination
Renal.
Amyvid Interactions
Not Applicable
Amyvid Adverse Reactions
Adverse Reactions
Headache, musculoskeletal pain, increased BP, nausea, fatigue, inj site reactions.
Amyvid Clinical Trials
See Literature
Amyvid Note
Not Applicable
Amyvid Patient Counseling
See Literature
