Important Safety Information
- Errors may occur in the estimation of brain amyloid beta neuritic plaque density during Amyvid image interpretation.
- The use of clinical information in the interpretation of Amyvid images has not been evaluated and may lead to an inaccurate assessment. Extensive brain atrophy as well as motion artifacts that distort the image may limit the ability to distinguish gray and white matter on an Amyvid scan.
Perform image interpretation independently of the patient’s clinical information. For cases where there is uncertainty as to the location of cortical signal, use co-registered anatomical imaging to improve localization of signal.
Radiation Risk
- Amyvid 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. Advise patients to hydrate before and after administration and to void frequently after administration.
The most common adverse reactions reported in clinical trials were headache (1.8%), musculoskeletal pain (0.7%), blood pressure increased (0.7%), nausea (0.7%), fatigue (0.5%), injection site reaction (0.5%), anxiety (0.4%), back pain (0.4%), claustrophobia (0.4%), dizziness (0.4%), feeling cold (0.4%), insomnia (0.4%) and neck pain (0.4%).
Amyvid (florbetapir F 18 injection) for intravenous use is supplied in multidose vials containing 500-1900 MBq/mL.
AM HCP ISI 24JUN2025