Vizamyl

Vizamyl is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment who are being evaluated for Alzheimer's disease (AD), other causes of cognitive decline, or in a selection of patients suitable for amyloid beta-directed treatment as described in the prescribing information for those products.

Negative Vizamyl Scan:

• Shows a clear contrast between white matter (bright) and gray matter (darker)
• Key regions have low uptake (below 50-60% peak intensity)
• Indicates sparse to no amyloid plaques
• In untreated patients, inconsistent with Alzheimer's disease diagnosis and reduces likelihood that cognitive impairment is due to AD
• Does not rule out future amyloid accumulation

Positive Vizamyl Scan:

• Shows reduced or lost contrast between gray and white matter
• At least one brain region has high gray matter uptake (above 50-60% peak intensity)
• Gray matter may appear as bright as or brighter than adjacent white matter
• Indicates moderate to frequent amyloid plaques are present
• Confirms amyloid plaques but doesn't definitively diagnose Alzheimer's - plaques can also occur in other neurologic conditions and normal aging

Key Point: Quantitative analysis can supplement visual assessment using FDA-authorized software for more precise measurements.

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

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.

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. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.

The most common side effects reported with Vizamyl are:

• flushing
• increased blood pressure
• headache
• nausea
• dizziness.

To report suspected side effects, contact GE HealthCare at 1-800-654-0118 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The clinical consequence of overdose 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.

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.

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 needed.

Nursing Mothers: Temporarily discontinue breastfeeding. A lactating woman should pump and discard breast milk for 24 hours after Vizamyl administration.

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.

Active ingredients: Each mL contains up to 2 mcg of flutemetamol and 150 MBq (4.05 mCi) of flutemetamol F 18 at reference date and time.

Inactive ingredients: 70 microL ethanol, 9 mg sodium chloride, and 4.98 mg polysorbate 80 (w/v) in 0.014 M aqueous phosphate buffer. The pH of the solution is between 6 and 8.5.

Vizamyl is supplied as an injection containing 150 MBq/mL (4.05 mCi/mL) of flutemetamol F 18 in up to 30 mL volume at reference date and time in a multiple-dose vial.

Vizamyl is manufactured for GE Healthcare, Medi-Physics, Inc., Arlington Heights, IL 60004.