Vizamyl™ (Flutemetamol F18 Injection)

Vizamyl™ is a radioactive diagnostic agent indicated for PET imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment.
AT A GLANCE

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The only FDA-approved amyloid imaging agent for color image interpretation

Rule out Alzheimer's

As an adjunt to clinical workup, Vizamyl can assist in ruling out AD1

Interpret with confidence

Vizamyl enables consistency and diagnostic certainty to scan interpretation

Support beyond the scan

Customers benefit from help with coding, coverage and payment questions
A CLINICAL CHALLENGE

Alzheimer’s disease (AD) is the most common cause of dementia, accounting for 60% to 80% of cases²

As an adjunct to clinical workup, imaging with Vizamyl can assist in ruling out AD, helping to more quickly determine the appropriate clinical path for your patient.
REAL-WORLD IMPACT

Vizamyl is the only amyloid imaging agent with FDA approval for color image interpretation as an adjunct to other evaluations.

In order to investigate the role of Vizamyl and the difference it may make in terms of diagnostic confidence and patient management, a prospective study was performed.1,2

- Vizamyl imaging led to changes in diagnosis and patient management plan in a substantial proportion of patients2

- Results from Vizamyl imaging increased physician confidence in their diagnosis from 69% to 88% in 87% of patients2

CONSISTENCY AND CERTAINTY

Regional review methodology may help improve diagnostic certainty.

A scan is deemed positive if any one or more of the 5 review regions is positive: frontal, lateral temporal, posterior cingulate/precuneus, inferolateral parietal and striatum

When all images are scaled to pons at 90% of maximum image intensity, it enables interpretation of white and grey matter uptake within and between cases. Helps consistency in scan interpretation

Support you need to scan and interpret with confidence

Learn more about supporting resources available for Vizamyl.

Reader training

From advanced information to recent guidelines and standards, our resources can help you understand how using Vizamyl can improve your dementia workflow.

Looking for medical information?

Smart Assistant can help you find medical information about GE HealthCare pharmaceutical imaging agents.

Vizamyl locator tool

Find a facility using Vizamyl in your area with our Vizamyl facility locator tool.

VizaView Application

Introducing VizaView, a new, case-based review application. Now available on the Apple Store.

References
  1. Vizamyl [prescribing information]. Arlington Heights, IL: GE HealthCare; 2020.
  2. Alzheimer’s Association. 2021 Alzheimer’s Disease Facts and Figures. Alzheimers Dement. 2021. https://www.alz.org/alzheimers-dementia/facts-figures. Accessed April 13 2021.

Important Safety Information

CONTRAINDICATIONS  

  • Known hypersensitivity to Vizamyl or any excipient, including polysorbate 80  

WARNINGS AND PRECAUTIONS

  • Hypersensitivity Reactions: Reactions such as flushing and dyspnea have been observed within minutes following administration and may occur in patients with no history of exposure to Vizamyl. Before administering Vizamyl, ask patients about prior reactions to drugs, especially those containing polysorbate 80. Have resuscitation equipment and trained personnel available  
  • Risk for Image Misinterpretation and Other Errors: Errors may occur while interpreting Vizamyl positron-emission tomography (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 
  • Radiation Risk: Like all radiopharmaceuticals, Vizamyl contributes to a patient’s long-term, cumulative radiation exposure and cancer risk. Ensure safe handling to protect patients and  healthcare workers from unintentional radiation exposure 

ADVERSE REACTIONS 

  • The most commonly reported adverse reactions in clinical trials were flushing (2%), increased blood pressure (2%), headache (1%), nausea and dizziness (1%)   

DRUG INTERACTIONS 

  • Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Vizamyl image results 

USE IN SPECIFIC POPULATIONS 

  • Pregnancy: All radiopharmaceuticals, including Vizamyl, have potential to cause fetal harm. There are no available data on Vizamyl in pregnant woman to evaluate drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcome  Advise women about the potential for adverse pregnancy outcomes based on the radiation dose and gestational timing of exposure 
  • Lactation: There are no data on presence of flutemetamol or its metabolites in human milk. The benefits of breastfeeding should be considered along with the mother’s clinical need for Vizamyl and any potential adverse effects on the breastfed child. Because many drugs are excreted in human milk and there is a potential for radiation exposure to nursing infants, advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for 24 hours after administration to minimize radiation exposure to a breastfeeding infant   
  • Pediatric Use: Vizamyl is not indicated for use in pediatric patients 
  • Geriatric Use: No overall differences in safety were observed between older and younger subjects  

OVERDOSAGE 

  • The clinical consequence of overdosing with Vizamyl has not been reported. It is unknown whether or not flutemetamol is dialyzable. The major risks of overdosage relate to increased radiation exposure and long-term risk for neoplasia. In case of overdose of radioactivity, hydration and frequent urination should be encouraged

Prior to Vizamyl administration, please read the full Prescribing Information for additional Important Safety Information.

To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

Important Safety Information

Vizamyl is a radioactive diagnostic agent 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 (AD) or other causes of cognitive decline. A negative Vizamyl 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 Vizamyl scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of 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. Vizamyl is an adjunct to other diagnostic evaluations

Limitations: A positive scan does not establish a diagnosis of AD or other cognitive disorder. The safety and effectiveness of Vizamyl have not been established for predicting the development of dementia or other neurologic conditions or for monitoring responses to therapies. 

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