AMYVID WAS EVALUATED IN THREE PIVOTAL STUDIES1

RELIABLE

Study 1: Assessed the correlation between amyloid plaques seen at autopsy and estimates for amyloid plaque density using Amyvid PET imaging1

DESIGN
  • 3 readers
  • Semiquantitative reading methodology (not intended for clinical use)
POPULATION
  • 35 terminally ill patients who received premortem Amyvid scans and then underwent autopsy (29 of which comprised the primary analysis set)

ACCURATE

Study 2: Assessed the sensitivity and specificity of a binary visual read methodology in patients who underwent autopsy (truth standard)1

DESIGN
  • 5 readers (trained in person)
  • Binary visual read methodology
POPULATION
  • 59 terminally ill patients* who received premortem Amyvid scans and then underwent autopsy to establish a truth standard.

REPRODUCIBLE

Study 3: Assessed the inter- and intra-reader image interpretation reproducibility in subjects with and without autopsy (truth standard)1

DESIGN
  • 5 readers (trained using electronic media)
  • Binary visual read methodology
POPULATION
  • 92 subjects who did not undergo autopsy (truth standard) in addition to 59 patients (same population from Study 2) with autopsy data
  • 33 randomly selected images were used to assess intra-reader reproducibility

*Twenty-nine (29) patients had an AD clinical diagnosis, 13 had another type of dementing disorder, 12 had no history of cognitive impairment, and 5 had MCI.
Twenty (20) healthy volunteers, 52 patients.

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EXPLORE DOSING & PROCEDURE

SELECT IMPORTANT SAFETY INFORMATION:
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

References

  1. Amyvid [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.

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

WARNINGS AND PRECAUTIONS

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

MOST COMMON ADVERSE REACTIONS

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 10JAN2014