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Vizamyl
Overview
What is Vizamyl?
Vizamyl contains flutemetamol F 18, a molecular imaging agent that binds to β-amyloid aggregates, and is intended for use with PET imaging of the brain. Chemically, flutemetamol F 18, is described as 2-[3-[F]fluoro-4-(methylamino) phenyl]-6-benzothiazolol. It has the molecular formula CH
FNOS, molecular weight 273.32, and the following structural formula:
Vizamyl is a sterile, non-pyrogenic, clear, colorless to slightly yellow radioactive solution for intravenous injection. Each milliliter (mL) of the no-carrier added Vizamyl product solution contains 150 MBq (4.05 mCi) of flutemetamol F 18 at reference date and time and up to 2 micrograms of flutemetamol. Each mL of the Vizamyl solution also contains 70 microliters ethanol, 9.0 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 6.0 and 8.5.
What does Vizamyl look like?
What are the available doses of Vizamyl?
Injection: 150 MBq/mL (4.05 mCi/mL) at reference date and time in 10 or 30 mL multi-dose vials ().
What should I talk to my health care provider before I take Vizamyl?
How should I use Vizamyl?
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:
Vizamyl is a radioactive drug and should be handled with safety measures to minimize radiation exposure during administration []. Use waterproof gloves and effective shielding, including lead-glass syringe shields when handling and administering Vizamyl. To minimize radiation dose to the bladder, encourage patients to hydrate before and after Vizamyl administration in order to permit frequent voiding. Encourage patients to void before and after imaging with Vizamyl and frequently thereafter for 24 hours following Vizamyl administration.
Radiopharmaceuticals, including Vizamyl, should be used by or under the control of physicians who are qualified by specific training and experienced in the safe use and handling of radioactive materials, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals.
What interacts with Vizamyl?
Sorry No Records found
What are the warnings of Vizamyl?
Sorry No Records found
What are the precautions of Vizamyl?
Sorry No Records found
What are the side effects of Vizamyl?
Sorry No records found
What should I look out for while using Vizamyl?
Vizamyl is contraindicated in patients with a history of hypersensitivity reaction to Vizamyl, polysorbate 80, or any other inactive ingredient in Vizamyl [].
What might happen if I take too much Vizamyl?
The clinical consequence of overdose with Vizamyl has not been reported. It is unknown whether or not flutemetamol is dialyzable. The major risks of overdose relate predominantly to increased radiation exposure, with long-term risks for neoplasia. In case of overdose of radioactivity, hydration and frequent urination should be encouraged to minimize radiation exposure to the patient; care should be taken to avoid contamination from the radioactivity eliminated by the patient.
How should I store and handle Vizamyl?
Store Vizamyl at 2° to 30°C (36° to 86°F). The product does not contain a preservative. Store Vizamyl within radiation shielding. Do not use Vizamyl after the expiry date and time stated on the label.Product: 50436-3945NDC: 50436-3945-1 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50436-3945-3 90 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50436-3945NDC: 50436-3945-1 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50436-3945-3 90 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 50436-3945NDC: 50436-3945-1 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 50436-3945-3 90 TABLET, EXTENDED RELEASE in a BOTTLE
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Flutemetamol F 18 binds to β-amyloid plaques in the brain and the F-18 isotope produces a positron signal that is detected by a PET scanner. In binding studies using postmortem human brain homogenates containing fibrillar β-amyloid, the dissociation constant (K) for flutemetamol was 6.7 nM.
Selectivity of [H]flutemetamol binding in post-mortem human brain sections was demonstrated using autoradiography, silver-stained protein, and immunohistochemistry (monoclonal antibody to β-amyloid) correlation studies.
Non-Clinical Toxicology
Vizamyl is contraindicated in patients with a history of hypersensitivity reaction to Vizamyl, polysorbate 80, or any other inactive ingredient in Vizamyl [].Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.
Antagonism has been demonstrated between clindamycin and erythromycin . Because of possible clinical significance, these two drugs should not be administered concurrently.
Hypersensitivity reactions such as flushing and dyspnea have been observed within minutes following Vizamyl administration. These reactions may occur in patients with no history of prior exposure to Vizamyl.
Before administering Vizamyl, ask patients about prior reactions to drugs, especially those containing polysorbate 80.
Have resuscitation equipment and trained personnel immediately available at the time of Vizamyl administration [].
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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