Product Information
Registration Status: ActiveSIN15441P
VIZAMYL SOLUTION FOR INJECTION 150 MBq/mL is approved to be sold in Singapore with effective from 2018-03-06. It is marketed by GE HEALTHCARE PTE LTD, with the registration number of SIN15441P.
This product contains Flutemetamol (18F) 150 MBq/ml at reference time in the form of INJECTION, SOLUTION (RADIOPHARMACEUTICAL). It is approved for INTRAVENOUS use.
This product is manufactured by SINGAPORE RADIOPHARMACEUTICALS PTE. LTD. in SINGAPORE.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Flutemetamol (18F) is a PET scanning radiopharmaceutical containing the radionuclide fluorine-18. It 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) or other causes of cognitive decline.
Indication
Flutemetamol F18 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) or other causes of cognitive decline.
Mechanism of Action
Fluorine-18 (F 18) is a cyclotron-produced radionuclide that decays by positron emission (β+ decay, 96.7%) and orbital electron capture (3.3%) to stable oxygen-18 with a physical half-life of 109.8 minutes. The positron can undergo annihilation with an electron to produce two gamma rays; the energy of each gamma ray is 511 keV. After flumetamol F18 is given intravenously, it accumulates in beta amyloid plaques in the brain, and thus becomes visible via positron emission tomography (PET).
Pharmacokinetics
- Absorption
- The time-activity curves for flutemetamol F 18 in the brain of subjects with positive scans shows continual signal increases from time zero through 30 minutes post administration, with stable values thereafter up to at least 120 minutes post-injection. Following intravenous injection of 185 MBq (5 mCi) of Vizamyl in humans, flutemetamol F 18 plasma concentrations declined by approximately 75% in the first 20 minutes post-injection, and by approximately 90% in the first 180 minutes.
- Distribution
- Metabolism
- The F 18 in circulation during the 30-120 minutes imaging window in plasma was principally associated with flutemetamol metabolites.
- Elimination
Toxicity
Most commonly reported adverse reactions were flushing (2%), headache (1%), increased blood pressure (2%), nausea (1%), and dizziness (1%).
Active Ingredient/Synonyms
2-[3-(18F)fluoro-4-(methylamino)phenyl]-1,3-benzothiazol-6-ol | [18F]-Flutemetamol | flutemetamol (18F) | Flutemetamol F 18 | Flutemetamol F-18 | Flutemetamol F18 | Flutemetamol (18F) |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.