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In conjunction with clinical assessment,AMYVID CAN HELPyou make a more informed evaluation and diagnosis for patients like me, with signs
and symptoms of cognitive decline." 1-3
Beta-amyloid deposition is a defining neuropathology of AD1,4
Evidence of amyloid plaque accumulation has been shown to be present when symptoms of cognitive impairment, due to AD, appear;
may precede the appearance of clinical symptoms by approximately 20 years5-7
Amyvid scans are interpreted using a binary visual read methodology (negative/positive)1
Beta-amyloid neuritic plaques may also be present in patients with other types of neurologic conditions, as well as older people with normal cognition; the presence of amyloid plaques alone does not establish a diagnosis of AD or other cognitive disorders
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.
KNOW
Unlikely that the cause of their cognitive decline is due to AD1
ACT
  • Potential to avoid unnecessary treatments8-10
  • Together, you and your patient can continue
    looking into other possible causes of their cognitive impairment
KNOW
Evidence of moderate to frequent beta-amyloid plaques in the brain is consistent with a neuropathological diagnosis of AD1
ACT
  • Scan results, along with clinical assessment, may help you decide appropriate diagnosis
    and management11
  • Together, you and your patient can determine an appropriate treatment plan

START TRAINING

References
  1. Amyvid [package insert]. Indianapolis, IN: Eli Lilly and Company; 2013.
  2. Clark CM, Schneider JA, Bedell BJ, et al; for the AV45-A07 Study Group. Use of florbetapir-PET for imaging beta-amyloid pathology. JAMA. 2011;305(3):275-283.
  3. 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.
  4. Jack CR, Jr, Albert MS, Knopman DS, et al. Introduction to the recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7(3):257-262.
  5. Alzheimer's Association. 2016 Alzheimer's disease facts and figures. Alzheimers Dement. 2016;12(4):459-509.
  6. Villemagne VL, Burnham S, Bourgeat P, et al; for the Australian Imaging Biomarkers and Lifestyle (AlBL) Research Group. Amyloid beta deposition, neurodegeneration, and cognitive decline in sporadic Alzheimer's disease: a prospective cohort study. Lancet Neurol. 2013;12(4):357-367.
  7. Hyman BT, Phelps CH, Beach TG, et al. National Institute on Aging-Alzheimer's Association guidelines for the neuropathologic assessment of Alzheimer's disease. Alzheimers Dement. 2012;8(1):1-13.
  8. Alzheimer's Association. 2011 Alzheimer's disease facts and figures. Alzheimers Dement. 2011;7(2):208-244.
  9. Mendez MF, Shapira JS, McMurtray A, et al. Preliminary findings: behavioral worsening on donepezil in patients with frontotemporal dementia. Am J Geriatr Psychiatry. 2007;15(1):84-87.
  10. Alzheimer's Disease International. World Alzheimer Report 2011: the benefits of early diagnosis and intervention. https://www.alz.co.uk/research/WorldAlzheimerReport2011.pdf. Published 2011. Accessed April 19, 2017.
  11. Dubois B, Padovani A, Scheltens P, Rossi A, Dell'Agnello G. Timely diagnosis for Alzheimer's disease: a literature review on benefits and challenges. J Alzheimers Dis. 2016;49(3):617-631.
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INDICATION AND IMPORTANT SAFETY INFORMATION FOR AMYVID (Florbetapir F 18 Injection)
INDICATIONS AND USAGE

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 (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.

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

Amyvid for intravenous use is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing 500-1900 MBq/mL Florbetapir F 18.

IMPORTANT SAFETY INFORMATION
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