Vizamyl (Flutemetamol F 18 Injection)


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 theNuclear 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 theNuclear 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.

  • 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 theNuclear 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

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

Important Safety Information

PRODUCT INDICATIONS AND USAGE: Vizamyl™ (Flutemetamol F 18 Injection) 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 (AD) and other causes of cognitive decline. A negative scan indicates sparse to no neuritic plaques, inconsistent with a 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 scan indicates moderate to frequent amyloid neuritic plaques. This amount of amyloid neuritic plaque has been shown to be present in patients with AD but may also be present in patients with other neurologic conditions as well as in 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.

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. Have resuscitation equipment and trained personnel available. 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. 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 NDA clinical trials were flushing, increased blood pressure, headache, nausea, and dizziness.

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.

SPECIFIC POPULATIONS - Pregnancy: It is not known whether Vizamyl can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. Radiopharmaceuticals, including Vizamyl, have the potential to cause fetal harm, the likelihood of which depends on the stage of fetal development and the magnitude of the radiopharmaceutical dose. Vizamyl should be given to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether flutemetamol is excreted in human milk. Because many drugs are excreted in human milk and there is a potential for radiation exposure to nursing infants, avoid use of Vizamyl in a breastfeeding mother or have the mother temporarily interrupt breastfeeding for 24 hours after exposure. 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. In case of overdose of radioactivity, hydration and frequent urination should be encouraged.

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

JB59094US| July 2018