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Vizamyl Generic Name & Formulations
Legal Class
Rx
General Description
Flutemetamol F 18 (150MBq/mL [4.05mCi/mL]); soln for IV inj; contains polysorbate 80.
Pharmacological Class
Radioactive diagnostic agent.
How Supplied
Multi-dose vials (30mL)—1
Manufacturer
Generic Availability
NO
Vizamyl Indications
Indications
For PET imaging of the brain to estimate β-amyloid neuritic plaque density in adults with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. As 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 efficacy not established for predicting development of dementia or other neurologic conditions, or for monitoring responses to therapies.
Vizamyl Dosage and Administration
Adult
See full labeling. Give 185MBq (5mCi), max 20μg mass dose, as a single IV bolus in a total volume of ≤10mL within 40 seconds. Follow injection with 5–15mL IV flush of 0.9% sterile NaCl. Starting 60–120mins after IV inj, acquire a 10–20min PET image. The radiation absorbed dose from 185MBq (5mCi) dose is 5.92mSv.
Children
Not established.
Vizamyl Contraindications
Contraindications
Allergy to polysorbate 80.
Vizamyl Boxed Warnings
Not Applicable
Vizamyl Warnings/Precautions
Warnings/Precautions
Risk of radiation exposure. Should only be used by trained and experienced physicians in the safe use and handling of radioactive materials to minimize radiation exposure. Risk of image misinterpretation and other errors. Perform image interpretation independently of patient's clinical information. Pregnancy. Nursing mothers: not recommended, or temporarily interrupt for 24hrs after Vizamyl exposure.
Vizamyl Pharmacokinetics
See Literature
Vizamyl Interactions
Not Applicable
Vizamyl Adverse Reactions
Adverse Reactions
Flushing, headache, increased blood pressure, nausea, dizziness; hypersensitivity reactions.
Vizamyl Clinical Trials
See Literature
Vizamyl Note
Not Applicable
Vizamyl Patient Counseling
See Literature
