Vizamyl is an imaging drug (also called a tracer) that is injected into a person’s bloodstream before a positron-emission tomography (PET) scan is performed. Currently, Vizamyl is the first-and-only imaging drug approved to provide color PET images that help your doctor estimate the amount of a protein called beta amyloid in the brain.

Although most people will develop some beta amyloid in the brain during aging, those with Alzheimer’s disease tend to develop more than those who
do not have the disease.

What to expect with Vizamyl

A short time after Vizamyl is injected into the bloodstream, it will attach to beta amyloid in the brain. An imaging device called a PET scanner will then take color images of the brain.

A radiologist can use these images to estimate how much beta amyloid there is. Your doctor will use this information, along with other tests, to try to better understand your condition. A Vizamyl image by itself cannot tell if you have, or will develop, a condition like Alzheimer’s disease. It also cannot tell how well any current treatment may be working.

This information does not replace having a conversation with your doctor about Vizamyl. If you have any questions, please speak to your doctor.

Important Risk and Safety Information About Vizamyl

Vizamyl is a radioactive drug that is injected into your bloodstream to help take an image of your brain. This image is taken using a special camera (called a PET camera). If you are an adult who has been having trouble remembering or thinking clearly, and you are being tested for conditions like Alzheimer’s disease (AD), your doctor may decide to do an imaging test using Vizamyl. This test can determine whether there is a protein called beta-amyloid in your brain. Your doctor will use this information, along with other tests, to try to better understand your condition. A Vizamyl test by itself cannot tell if you have or will get a condition like AD, or tell how well any treatment you are on may be working.

You should not take Vizamyl if:
  • You are sensitive to polysorbate 80 or any other ingredients of Vizamyl. Your doctor can help you understand what these compounds are
Warnings:
  • Vizamyl can cause reactions such as flushing or shortness of breath. Be sure to tell your doctor if you have had reactions to other drugs, especially any that contain polysorbate 80
  • Like other radioactive drugs, Vizamyl adds to your lifetime radiation exposure. Long-term radiation exposure is related to increased risk of cancer
The most common side effects of Vizamyl:
  • Flushing, increased blood pressure, headache, nausea, or dizziness has occurred in one out of every 50 patients
What you should know about taking Vizamyl with other medications:
  • Studies have not been conducted to show which, if any, drugs may interfere with the Vizamyl test results. Be sure to tell your doctor what drugs you are taking so that he or she can decide whether you should stop any of them for a period of time before your Vizamyl test
Before taking Vizamyl, tell your doctor about all of your medical conditions, including if you:
  • Are pregnant or plan to become pregnant. It is not known if Vizamyl will harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if Vizamyl passes into your breast milk. Talk with your doctor about the best way to feed your baby if you take Vizamyl

Always talk with your doctor if you have any questions about PET imaging or Vizamyl. Only doctors who have successfully completed the Vizamyl Electronic Reader Training Program should read Vizamyl images.

You are encouraged to report negative side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or contact GE Healthcare at 1-800-654 0118.


If you have any questions, please speak to your doctor. For additional information, please see the Full Prescribing Information for Vizamyl.