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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-[18F]fluoro-4-(methylamino) phenyl]-6-benzothiazolol. It has the molecular formula C14H1118FN2OS, molecular weight 273.32, and the following structural formula:
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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.
Fluorine-18 (F 18) is a cyclotron-produced radionuclide that decays by positron emission (ß+ 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 (Table 3).
Table 3: Principal Radiation Emission Data – Fluorine-18
| Radiation | Energy (keV) | Abundance (%) |
| Gamma | 511 | 193.4 |
| Positron | 249.8 | 96.7 |
The point credit air-kerma rate constant for F-18 is 3.74E -17 Gy m²/(Bq s); this coefficient was formerly defined as the specific gamma-ray constant of 5.7 R/ hr/mCi at 1 cm. The first half-value thickness of lead (Pb) for F 18 gamma rays is approximately 6 mm. The relative reduction of radiation emitted by F-18 that results from various thicknesses of lead shielding is shown in Table 4. The use of ~8 cm of Pb will decrease the radiation transmission (i.e., exposure) by a factor of about 10,000.
Table 4: Radiation Attenuation of 511 keV Gamma Rays by Lead Shielding
| Shielding Thickness cm of lead (Pb) | Coefficient of Attenuation |
| 0.6 | 0.5 |
| 2 | 0.1 |
| 4 | 0.01 |
| 6 | 0.001 |
| 8 | 0.0001 |
Clinical trials are conducted under widely varying conditions and adverse reaction rates observed in the clinical trials of Vizamyl cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In clinical trials, 761 adults (367 men and 394 women, 91% Caucasian) with a mean age of 62 years (range 18-93 years) received Vizamyl. Most subjects (530, 70%) received a dose of 185 MBq (5 mCi).
One subject out of 761 administered Vizamyl experienced a serious hypersensitivity reaction with flushing, dyspnea and chest pressure within minutes following Vizamyl administration and recovered with treatment.
Most adverse reactions were mild to moderate in intensity and resolved spontaneously. The most commonly reported adverse reactions (occurring in at least 1% of subjects) in Vizamyl-treated subjects are shown in Table 2.
Table 2: Adverse Reactions Reported in Clinical Trials of Vizamyl (N = 761 subjects)
| Adverse Reaction | N (percent of patients) |
|---|---|
| Flushing | 16 (2%) |
| Increased blood pressure | 13 (2%) |
| Headache | 10 (1%) |
| Nausea | 8 (1%) |
| Dizziness | 8 (1%) |
The following adverse reactions have been identified during postapproval use of Vizamyl. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune system disorders: anaphylactic reactions
Pharmacodynamic 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.
Within a clinical study of patients with a range of cognitive impairment, some patients were receiving the following medications: donepezil, galantamine, memantine, rivastigmine. Mean cortical Standardized Uptake Value (SUV) ratios did not differ between the patients taking or not taking these concomitant medications.
Included as part of the PRECAUTIONS section.
Serious hypersensitivity reactions including anaphylaxis, presenting with flushing, dyspnea, and hypotension, have been observed within minutes following Vizamyl administration. These reactions may occur in patients with no history of exposure to Vizamyl [see Adverse Reactions (6.1, 6.2)].
Obtain a history of allergy or hypersensitivity reactions. Always have resuscitation equipment and trained personnel immediately available at the time of Vizamyl administration. If a hypersensitivity reaction is suspected, immediately discontinue the injection and initiate appropriate therapy. Vizamyl is contraindicated in patients with a history of hypersensitivity to Vizamyl or polysorbate 80 [see Contraindications (4)].
Errors may occur while using Vizamyl PET images to estimate brain neuritic plaque density [see Clinical Studies (14)].
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 [see Dosage and Administration (2.5)]. Motion artifacts may distort the image [see Dosage and Administration (2.3)].
Vizamyl scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in the future.
Vizamyl, similar to other radiopharmaceuticals, contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration (2.1)].
Animal studies have not been performed to evaluate the carcinogenicity potential of flutemetamol. Flutemetamol was positive for mutagenicity in two in vitro assays: the bacterial reverse mutation assay (Ames test) and the mouse lymphoma assay.
Flutemetamol was negative for genotoxicity after in vivo exposure in rats to flutemetamol at the highest cumulative dose level tested, as measured in bone marrow micronucleus assays (157 and 27 microgram/kg/day for 2 and 14 days respectively) and an unscheduled DNA synthesis assay in rat hepatocytes (39 microgram/kg/day).
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.
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)].
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 in vitro binding studies using postmortem human brain homogenates containing fibrillar β-amyloid, the dissociation constant (Kd) for flutemetamol was 6.7 nM.
Selectivity of [3H]flutemetamol binding in post-mortem human brain sections was demonstrated using autoradiography, silver-stained protein, and immunohistochemistry (monoclonal antibody to β-amyloid) correlation studies.
Following intravenous injection, flutemetamol F 18 diffuses across the human blood-brain barrier and produces a radioactivity signal detectable throughout the brain. Subsequently, cerebral perfusion decreases the brain flutemetamol F 18 content, with differential retention of the drug in cortical areas that contain β-amyloid aggregates compared to areas that lack the aggregates. 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. Differences in signal intensity between brain regions that specifically retain flutemetamol F 18 and brain regions with nonspecific retention of the drug form the basis of image interpretation methods [see Dosage and Administration (2.5)].
The test-retest distribution of flutemetamol F 18 was evaluated in 5 subjects with probable AD who underwent two administrations of flutemetamol F 18 (followed by PET scans) separated by a time period of 1 to 4 weeks. Images were reproducible when evaluated semi-quantitatively using an automated assessment of SUV in pre-specified cortical regions of brain.
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. The F 18 in circulation during the 30-120 minutes imaging window in plasma was principally associated with flutemetamol metabolites. Excretion was approximately 37% renal (28-45%; n=6) and 52% hepatobiliary (40-65%; n=6).
Inform patients of the risk of hypersensitivity reactions, including anaphylaxis, and instruct them to alert healthcare providers immediately if they experience signs and symptoms of a hypersensitivity reaction [see Warnings and Precautions (5.1)].
Instruct patients to inform their healthcare provider if they:
Instruct patients to increase their level of hydration before and after receiving Vizamyl (Flutemetamol F 18 Injection) and to void frequently for the first 24 hours following Vizamyladministration.
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Manufactured for GE Healthcare, Medi-Physics, Inc., Arlington Heights, IL 60004 U.S.A. Vizamyl is a trademark of General Electric Company or one of its subsidiaries.
GE and the GE Monogram are trademarks of General Electric Company.
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