AMYVID PROVIDES OBJECTIVE EVIDENCE IN THE DIAGNOSTIC EVALUATION1-3

Amyvid is indicated 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 and other causes of cognitive decline.

  • A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder

Amyvid is a nonglucose-based PET tracer intended for use in adult patients undergoing clinical evaluation for AD and other causes of cognitive decline1

  • Amyvid is injected into the bloodstream, where it crosses the blood-brain barrier and specifically binds to amyloid plaques
  • Amyvid is a radioactive diagnostic agent that binds to amyloid plaques and the fluorine 18 (F 18) isotope produces a positron signal that is detected by a PET scanner1,4
  • Radiation exposure level of 7 mSv is within the range seen with other FDA-approved PET tracers
  • (1 to 12 mSv)1,5-7
  • The safety and effectiveness of Amyvid have not been established for predicting the development of dementia or other neurologic condition, or for monitoring responses to therapies

Minimal patient preparation required prior to scan1,8

  • No contraindications
  • No glucose monitoring or fasting required

At the first sign of clinical symptoms, order Amyvid for your patients with cognitive decline

References

  1. Amyvid [Prescribing Information]. Indianapolis, IN: 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. Use of Florbetapir-PET for imaging β-amyloid pathology. JAMA. 2011;305(3):275-283.
  4. Choi SR, Golding G, Zhuang Z, et al. Preclinical properties of 18F-AV-45: a PET agent for Aß plaques in the brain. J Nucl Med. 2009;50(11):1887-1894.
  5. Ammonia N 13 Injection [package insert]. Manhasset, NY: Feinstein Institute for Medical Research; 2011.
  6. CardioGen-82 [package insert]. Princeton, NJ: Bracco Diagnostics Inc.; 2012.
  7. Sodium Fluoride F 18 Injection [package insert]. Knoxville, TN: Siemens Molecular Imaging; 2011.
  8. Trembath L, Newell M, Devous MD. Technical Considerations in Brain Amyloid PET Imaging with 18F-Florbetapir. J Nucl Med Technol. 2015;43:175-184.

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