Amyvid is indicated for PET imaging of the brain to estimate amyloid plaque density in adult patients with cognitive impairment who are being evaluated for AD and other causes of cognitive decline. Amyvid is an adjunct to other diagnostic evaluations.
IMPORTANT SAFETY INFORMATION
Risk for Image Misinterpretation and Other Errors
- Errors may occur in the Amyvid estimation of brain neuritic plaque density during image interpretation
- Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Amyvid images has not been evaluated and may lead to errors. Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the Amyvid scan as well as motion artifacts that distort the image
- Amyvid scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in the future
- 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 (0.7%), blood pressure increased (0.7%), nausea (0.7%), fatigue (0.5%), and injection site reaction (0.5%)
Please see full Prescribing Information for Amyvid.
AM HCP ISI 14SEP2022