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CHOOSE AMYVID TO AID IN THE DIAGNOSIS OF ALZHEIMER’S DISEASE (AD)1,2

Amyvid provides objective evidence

Amyvid: PET imaging of the brain that estimates beta-amyloid plaque density in adult patients with cognitive impairment may aid in the diagnosis of AD.1-3

NEGATIVE AMYVID PET SCAN


Brain negative Amyvid PET scan

POSITIVE AMYVID PET SCAN


Brain positive Amyvid PET scan

Amyvid scans1:

  • Are interpreted using a binary visual read methodology (negative/positive)
  • Are used as an adjunct to other diagnostic evaluations
  • Should only be read by physicians who complete a comprehensive Amyvid training program

The objective of Amyvid image interpretation is to provide an estimate of the brain beta-amyloid neuritic plaque density, not to make a clinical diagnosis. Image interpretation is performed independently of a patient’s clinical features and relies upon the recognition of unique image features.1

Amyvid clinical studies:

  • Amyvid was evaluated in 3 clinical studies that examined images from healthy adult subjects as well as subjects with a range of cognitive disorders, including some terminally ill patients who had agreed to participate in a postmortem brain donation program1
  • All were single-arm studies in which subjects underwent an Amyvid injection and scan and then had images interpreted by multiple independent readers who were masked to all clinical information1
  • Image interpretations used co-registration with CT scans when PET scans were performed on dual PET/CT scanners1

SELECT IMPORTANT SAFETY INFORMATION
Risk for Image Misinterpretation and Other Errors
Errors may occur during Amyvid image interpretation. Image interpretation should be performed independently of the patient’s clinical information. Amyvid scan results are indicative of plaque content only at the time of image acquisition and a negative scan does not preclude the development of brain amyloid in the future.

Learn more about the accuracy, reliability and reproducibility of Amyvid

SEE AMYVID EFFICACY Right

CT=computed tomography; PET=positron emission tomography.

References:

  1. Amyvid (florbetapir F 18 injection) Prescribing Information. Lilly USA, LLC.
  2. McKhann GM, Knopman DS, Chertkow H, et al. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7(3):263-269.
  3. Clark CM, Schneider JA, Bedell BJ, et al; for the AV45-A07 Study Group. Use of Florbetapir-PET for imaging β-amyloid pathology. JAMA. 2011;305(3):275-283.

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

Radiation Risk

  • 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

Indication

Amyvid is a radioactive diagnostic agent for Positron Emission Tomography (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 (AD) and other causes of cognitive decline.

A negative Amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. 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 AD, 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.

Amyvid for intravenous use is supplied in multidose vials containing 500-1900 MBq/mL Florbetapir F 18.

Limitations of Use:

  • A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder
  • Safety and effectiveness of Amyvid have not been established for:
    • Predicting development of dementia or other neurologic condition
    • Monitoring responses to therapies