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Amyvid can confirm amyloid pathology and help identify patients with Alzheimer’s disease (AD) who are indicated for amyloid beta–directed therapy1

Consider using Amyvid in the following settings1:

  • Confirming amyloid pathology as part of the evaluation process for AD and other causes of cognitive decline
  • Selecting appropriate patients who are indicated for amyloid beta-directed therapy

Amyloid PET scans have been used to assess reduction of plaque in some clinical trials of amyloid beta–directed therapies.1

With approved therapies focusing on earlier stages in the disease continuum, confirming the presence of AD pathology to aid in determining an AD diagnosis as early as possible is essential.2,3

Acknowledging the presence or absence of AD biomarkers—like amyloid beta plaques—at symptom onset, in combination with clinical assessment in patients with MCI, may allow for a more informed decision, an earlier diagnosis, and consideration of timely treatment options.2,4,5

Knowing that amyloid beta plaques are not present may support the choice to assess for other causes of cognitive impairment and help avoid unnecessary treatment.6-9

MCI=mild cognitive impairment.

ALZHEIMER’S DISEASE (AD) CAN BE DIFFICULT TO DIAGNOSE2,10,11

An AD diagnosis can be challenging due to overlapping symptoms with other causes of cognitive impairment, particularly in early stages when symptoms may mimic the natural aging process.2,10,11

Objective evidence can help increase confidence in AD diagnosis12

Blue brain head icon

With the approval of amyloid-targeting therapies (ATTs), confirming amyloid pathology as early as possible is more important than ever for patients being assessed for AD.2,3,13

  • Nearly 1 in 3 people clinically diagnosed with AD based on symptoms did not test positive for amyloid plaques14-16
  • Knowing that amyloid beta plaques are not present may support the choice to assess for other causes of cognitive impairment and help avoid unnecessary treatment6-9

Historically, diagnosis of AD has been delayed by approximately 3 years after symptom onset. Imagine how having earlier objective evidence of the presence or absence of AD pathology could help you to make a more confident and timely diagnosis than clinical evaluations alone.2,4,17

Based on a comparison of diagnostic confidence between pre- and post-amyloid PET scans in a study of patients with cognitive impairment of unknown etiology or suspected AD, diagnostic uncertainty was reduced from 72% before amyloid PET scans to 16% after amyloid PET scans.14

Learn more about the efficacy of Amyvid

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PET=positron emission tomography.

References:

  1. Amyvid (florbetapir F 18 injection). Prescribing Information. Lilly USA, LLC.
  2. Porsteinsson AP, Isaacson RS, Knox S, et al. Diagnosis of early Alzheimer’s disease: clinical practice in 2021. J Prev Alzheimers Dis. 2021;8:371-386.
  3. Aisen PS, Cummings J, Jack CR Jr, et al. On the path to 2025: understanding the Alzheimer’s disease continuum. Alzheimers Res Ther. 2017;9(1):60. doi:10.1186/s13195-017-0283-5
  4. Balasa M, Gelpi E, Antonell A, et al; for Neurological Tissue Bank/University of Barcelona/Hospital Clinic NTB/UB/HC Collaborative Group. Clinical features and APOE genotype of pathologically proven early-onset Alzheimer disease. Neurology. 2011;76(20):1720-1725.
  5. Sabbagh MN, Lue LF, Fayard D, et al. Increasing precision of clinical diagnosis of Alzheimer’s disease using a combined algorithm incorporating clinical and novel biomarker data. Neurol Ther.2017;6(suppl 1):S83-S95.
  6. Ty D, McDermott M. Building workforce capacity to improve detection and diagnosis of dementia. Milken Institute; 2021. Accessed August 12, 2021. https://milkeninstitute.org/sites/default/files/202105/Building%20Dementia%20Workforce.pdf
  7. Prince M, Bryce R, Ferri C. World Alzheimer Report 2011: the benefits of early diagnosis and intervention. Alzheimer’s Disease International; September 2011. Accessed October 19, 2016. https://www.alz.co.uk/research/WorldAlzheimerReport2011.pdf
  8. Weidman DA, Zamrini E, Sabbagh MN, et al. Added value and limitations of amyloid-PET imaging: review and analysis of selected cases of mild cognitive impairment and dementia. Neurocase.2017;23(1):41-51.
  9. Shea YF, Barker W, Greig-Gusto MT, et al. Utility of amyloid PET scans in the evaluation of patients presenting with diverse cognitive complaints. J Alzheimer’s Dis. 2018;66(4):1599-1608.
  10. Alzheimer’s Association. 2022 Alzheimer’s disease facts and figures. Alzheimers Dement. 2022;18(4):700-789.
  11. 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.
  12. Clark CM, Schneider JA, Bedell BJ, et al; for AV45-A07 Study Group. Use of florbetapir-PET for imaging β-amyloid pathology. JAMA. 2011;305(3):275-283. doi:10.1001/jama.2010.2008
  13. Pemberton HG, Collij LE, Heeman F, et al; on behalf of AMYPAD consortium. Quantification of amyloid PET for future clinical use: a state-of-the-art review. Eur J Nucl Med Mol Imaging.2022;49(10):3508-3528.
  14. Rabinovici GD, Gatsonis C, Apgar C, et al. Association of amyloid positron emission tomography with subsequent change in clinical management among medicare beneficiaries with mild cognitive impairment or dementia. JAMA. 2019;321(13):1286-1294. doi:10.1001/jama.2019.2000
  15. Grundman M, Pontecorvo MJ, Salloway SP, et al. Potential impact of amyloid imaging on diagnosis and intended management in patients with progressive cognitive decline. Alzheimer Dis Assoc Disord. 2013;27(1):4-15.
  16. Jack CR Jr, Bennett DA, Blennow K, et al. NIA-AA Research Framework: toward a biological definition in Alzheimer’s disease. Alzheimers Dement. 2018;14(4):535-562.
  17. Liss JL, Seleri Assunção S, Cummings J, et al. Practical recommendations for timely, accurate diagnosis of symptomatic Alzheimer’s disease (MCI and dementia) in primary care: a review and synthesis. J Intern Med. 2021;290(2):310-334. doi:10.1111/joim.13244

Important Safety Information

Risk for Image Misinterpretation and Other Errors
  • Errors may occur in the estimation of brain amyloid beta neuritic plaque density during Amyvid image interpretation.
  • The use of clinical information in the interpretation of Amyvid images has not been evaluated and may lead to an inaccurate assessment. Extensive brain atrophy as well as motion artifacts that distort the image may limit the ability to distinguish gray and white matter on an Amyvid scan.

Perform image interpretation independently of the patient’s clinical information. For cases where there is uncertainty as to the location of cortical signal, use co-registered anatomical imaging to improve localization of signal.

Radiation Risk

  • Amyvid 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. Advise patients to hydrate before and after administration and to void frequently after administration.

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%), injection site reaction (0.5%), anxiety (0.4%), back pain (0.4%), claustrophobia (0.4%), dizziness (0.4%), feeling cold (0.4%), insomnia (0.4%) and neck pain (0.4%).

Amyvid (florbetapir F 18 injection) for intravenous use is supplied in multidose vials containing 500-1900 MBq/mL.

AM HCP ISI 24JUN2025

Please see Full Prescribing Information for Amyvid.

Indication

Amyvid is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for:

  • Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline
  • Selection of patients who are indicated for amyloid beta–directed therapy as described in the prescribing information of the therapeutic products