Vizamyl

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: Known hypersensitivity to Vizamyl or any excipient, including polysorbate 80.

Please see Product Indications and Additional Important Safety Information About Vizamyl at the bottom of this page.
Prior to Vizamyl administration, please read the Full Prescribing Information.

For more information about Vizamyl, including efficacy and safety, please visit the Nuclear Pharmacy Information button. Vizamyl Brand Website.

For the visualization of β-amyloid neuritic plaque density in patients being evaluated for cognitive disorders, including Alzheimer's disease...Introducing the first-and-only amyloid imaging agent with FDA approval for color image interpretation.

Vizamyl is indicated for positron-emission tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline.¹

A negative Vizamyl scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of Alzheimer's disease at the time of image acquisition
- A negative scan reduces the likelihood that a patient's cognitive impairment is due to Alzheimer's disease
A positive Vizamyl scan indicates moderate to frequent amyloid neuritic plaques
- Neuropathological examination has shown that this amount of amyloid neuritic plaque is present in patients with Alzheimer's disease, but it may also be present in patients with other types of neurologic conditions as well as in older people with normal cognition
Vizamyl is an adjunct to other diagnostic evaluations

Limitations of Use

A positive scan does not establish a diagnosis of Alzheimer's disease or other cognitive disorders
Safety and effectiveness of Vizamyl have not been established for:
- Predicting development of dementia or other neurologic conditions
- Monitoring responses to therapies

1. Vizamyl [prescribing information]. Arlington Heights, IL: GE Healthcare; 2017.

Interpreting Scans

See Important Safety Information About Vizamyl at the bottom of this page.

Prior to Vizamyl administration, please read the Full Prescribing Information.

For more information about Vizamyl, including efficacy and safety, please visit the Nuclear Pharmacy Information button. Vizamyl Brand Website.

Color images provide a visualization of flutemetamol uptake that can be shared with referring physicians, patients, and caregivers to help enhance communication.

Vizamyl positron-emission tomography (PET) images are displayed using a color scale with a continuous progression of low through high intensity (eg, rainbow or Sokoloff) ¹

positive scan

f, frontal; s, striatal; lt, lateral temporal.
Representative positive scan; scans will vary. Vizamyl images should be interpreted only by readers who have completed the Vizamyl Electronic Reader Training Program provided by GE Healthcare and available at Readvizamyl.com. For more information, contact Medical Affairs at 800 654 0118 (option 2, then option 3).

Image Misinterpretation: Errors may occur while interpreting Vizamyl PET images. Image interpretation is performed independently of the patient's clinical information. The use of clinical information in the interpretation of Vizamyl images has not been evaluated and may lead to errors. Extensive brain atrophy may limit the ability to distinguish grey and white matter on a Vizamyl scan. Motion artifacts may distort the image. Images should be interpreted only by readers who have completed a reader training program available from GE Healthcare.

Vizamyl PET images in color help reveal amyloid deposition.¹

Negative Scan
A negative Vizamyl scan indicates sparse to no amyloid neuritic plaques.

Shows more radioactivity in the white matter than in the grey matter, creating clear grey-white matter contrast

Positive Scan
A positive Vizamyl scan indicates moderate to frequent amyloid neuritic plaques.

Shows at least one cortical region with reduction or loss of the normally distinct grey-white matter contrast
Has one or more regions with increased cortical grey matter signal and/or reduced or absent grey-white matter contrast
May have one or more regions in which grey matter radioactivity is as intense as, or exceeds, the intensity in adjacent white matter

Images at right:
Representative negative and positive scans; scans will vary. Images displayed using the rainbow color scale. Vizamyl images should be interpreted only by readers who have completed the Vizamyl Electronic Reader Training Program provided by GE Healthcare and available at Readvizamyl.com. For more information, contact Medical Affairs at 800 654 0118 (option 2, then option 3).

Click here to see the Full Prescribing Information for additional details on imaging and interpretation, including selection of appropriate color scales.

1. Vizamyl [prescribing information]. Arlington Heights, IL: GE Healthcare; 2013.

product-product-categories-nuclear-imaging-agents-vizamyl-interpreting-scans-figures.jpg

Reader Training

See Important Safety Information About Vizamyl at the bottom of this page.

Prior to Vizamyl administration, please read the Full Prescribing Information.

For more information about Vizamyl, including efficacy and safety, please visit the Nuclear Pharmacy Information button. Vizamyl Brand Website.

Vizamyl Electronic Reader Training Program

GE Healthcare offers an online electronic reader training program for the proper interpretation of Vizamyl positron-emission tomography (PET) images in color.

Vizamyl images should be interpreted only by readers who successfully complete the Vizamyl Electronic Reader Training Program
You can access the training program at Readvizamyl.com

t-categories-nuclear-imaging-agents-vizamyl-vizamyl-electronic-reader-training-program.jpg

Reimbursement

See Important Safety Information About Vizamyl at the bottom of this page. Prior to Vizamyl administration, please read the Full Prescribing Information.

Reimbursement for Vizamyl

As with all β-amyloid detection agents, Medicare will not cover the use of Vizamyl unless patients are involved in approved clinical studies. Please contact GE Healthcare Medical Affairs at 800 654 0118 (option 2, then option 3) for more information.

For non-Medicare coverage, please contact your patient's insurer to verify benefits. Insurance policies vary and preauthorization will likely be required to establish the medical necessity for the procedure. Payment for Vizamyl and the positron-emission tomography (PET) scan would be based on the terms of your facility's contractual agreement with the insurer.

Professional Resources and Disclosures

See Important Safety Information About Vizamyl at the bottom of this page. Prior to Vizamyl administration, please read the Full Prescribing Information.

Please see the following for more information:

HIPAA Policy

Safe Harbor Privacy Policy

California Declaration of Compliance

Licensing and collaboration

JB59094US| July 2018

WIPRO GE HEALTHCARE PVT LTD

No. 4, Kadugodi Industrial Area,
Bangalore 560067,
Karnataka, India
CIN: U33111KA1990PTC01606

Thank you!

We received your request for assistance.

A GE Healthcare specialist will be reaching out shortly.

Something went wrong

We will check and get back.

Try Again

JB01363IN March 2023