Your Vizamyl™ journey begins here
At a Glance
Why Vizamyl?
How does Vizamyl work?
PET is a non-invasive imaging tool that takes pictures like a CT scan. The brain images can then be evaluated for amyloid plaque.
Understanding your diagnosis
YOUR VIZAMYL JOURNEY
Everything you need to know about the Vizamyl imaging procedure
BEFORE THE EXAM
Follow your doctor’s orders when preparing for this test.
ON THE DAY OF THE EXAM
Drink plenty of fluids and wear loose, comfortable clothing.
DURING THE EXAM
During the imaging test, you will need to lie very still.
AFTER THE EXAM
Your doctor will explain the test results and what they mean for your treatment options.
Important Safety Information
Vizamyl — Important Safety Information for Consumers
Product Use
Vizamyl (flutemetamol F 18 injection) is used for positron-emission tomography (PET) imaging of the brain to estimate amyloid 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 scan would be inconsistent with a diagnosis of AD at the time of image acquisition and these results reduce the likelihood that a patient’s cognitive impairment is due to AD. A positive scan represents moderate to frequent amyloid plaques which may be present in patients with AD as well as in patients with other neurologic conditions and older people with normal cognition. Vizamyl is used with other diagnostic evaluations.
Limitations
A positive scan does not mean you have AD or other cognitive disorders. The safety and effectiveness of Vizamyl have not been established for predicting the development of dementia or other neurologic conditions or for monitoring your response to therapy.
Important Safety Information About Vizamyl (flutemetamol F 18 injection)
You should not be given Vizamyl if:
You are allergic to any of the ingredients of Vizamyl, including polysorbate 80. Your healthcare professional (HCP) can help you understand what the drug ingredients are.
What is the most important information you should know about Vizamyl?
• Allergies: Tell your HCP if you are allergic to any medications or a substance called polysorbate 80.
• Reactions such as flushing and shortness of breath have been seen within minutes following administration of Vizamyl.
• Radiation Risk: Vizamyl contributes to your long-term cumulative radiation exposure and cancer risk. Please be well hydrated and urinate regularly for the 24 hours after your test.
The most common side effects of Vizamyl include:
Flushing, increased blood pressure, headache, nausea and dizziness.
Make sure you tell your HCP:
• All the medications you are taking, including any over-the-counter medications.
• If you are pregnant, may be pregnant or plan to become pregnant.
• If you are breastfeeding.
Children and Elderly:
• Vizamyl should not be used in those less than 18 years old.
• Studies showed no difference in safety between those over 65 years old and those between 18 and 65 years old.
The safety information included here is not comprehensive. If you have any questions, please be sure to discuss them with your HCP.
For more information about Vizamyl, call GE HealthCare Customer Service at 800 292 8514.
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800 654 0118 (option 2, then option 1) or by email at GPV.drugsafety@ge.com or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.
Please see the full Prescribing Information for Vizamyl HERE.