Basic Information
VIZAMYL SOLUTION FOR INJECTION 150 MBq/mL
INJECTION, SOLUTION (RADIOPHARMACEUTICAL)
Regulatory Information
SIN15441P
March 6, 2018
Prescription Only
Therapeutic
INTRAVENOUS
August 10, 2023
May 30, 2025
XV09AX04
Company Information
Active Ingredients
Strength: 150 MBq/ml at reference time
Detailed Information
Contraindications
**4 CONTRAINDICATIONS** Vizamyl is contraindicated in patients with a history of hypersensitivity reaction to Vizamyl, polysorbate 80, or any other inactive ingredient in Vizamyl \[ _see Warnings and Precautions (5.1)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\].
Indication Information
**1 INDICATIONS AND USAGE** 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 (AD) and 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 amyloid neuritic plaque is present in patients with AD, but 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 Vizamyl scan does not establish a diagnosis of AD or other cognitive disorder. - Safety and effectiveness of Vizamyl have not been established for: - Predicting development of dementia or other neurologic condition. - Monitoring responses to therapies.