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Vizamyl is a brand name for Flutemetamol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: This medicinal product is for diagnostic use only. VIZAMYL is a radiopharmaceutical medicinal product indicated for Positron Emission Tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other…
Verbatim from this product's EMA label. Tap a section to expand.
A PET scan with flutemetamol (18F) should be requested by clinicians experienced in the clinical management of neurodegenerative disorders. VIZAMYL images should only be interpreted by readers trained in the interpretation of PET images with flutemetamol (18F).
A recent co-registered Computed Tomography (CT) scan or Magnetic Resonance (MR) scan of the patient to obtain a fused PET-CT or PET-MR image is recommended in cases of uncertainty about the location of grey matter and of the grey/white matter border in the PET scan (see section
Summary of the safety profile The overall safety profile of VIZAMYL is based on data from its administrations to 831 subjects. Tabulated list of adverse reactions The frequencies of adverse reactions are defined as follows: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The following adverse reactions are listed in the Table 1 below: 9 Table 1 List of adverse reactions System Organ Class Common Uncommon Immune system disorders Anaphylactoid reaction Psychiatric disorders Anxiety Nervous system disorders Dizziness Headache Hypoaesthesia Hypotonia Dysgeusia Tremor Eye disorders Eye swelling Ear and labyrinth disorders Vertigo Cardiac disorders Palpitations Vascular disorders Flushing Pallor Respiratory, thoracic and mediastinal disorders Dyspnoea Hyperventilation Throat irritation Gastrointestinal disorders Nausea Vomiting Dyspepsia Abdominal discomfort Oral discomfort Skin and subcutaneous tissue disorders Facial hypoaesthesia Pruritus Rash Skin tightness Swelling face Musculoskeletal and connective tissue disorders Back pain Muscle tightness Musculoskeletal pain Reproductive system and breast disorders Erectile dysfunction General disorders and administration site conditions Chest discomfort Feeling hot Asthenia Fatigue Feeling abnormal Feeling cold Infusion site pain Oedema Pyrexia Investigations Increased blood pressure Blood glucose decreased Blood lactate dehydrogenase increased Neutrophil count increased Respiratory rate increased Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
9 mSv when the maximal recommended activity of 185 MBq of flutemetamol (18F) is administered. These adverse events are expected to occur with low probability. 4). 10 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
4 Interpretation of VIZAMYL images). Posology Adults 3 The recommended activity for an adult is 185 MBq of flutemetamol (18F) administered intravenously (as a bolus within approximately 40 seconds). The volume of the injection should be not less than 1 mL and not more than 10 mL.
Special populations Extensive dose-range and adjustment studies with the medicinal product in normal and special populations have not been performed. Elderly patients No dose adjustment is recommended based on age. Renal and hepatic impairment VIZAMYL has not been studied in patients with significant renal or hepatic impairment.
4). The pharmacokinetics of flutemetamol (18F) in patients with renal or hepatic impairment has not been characterised. Paediatric population There is no relevant use of VIZAMYL in the paediatric population. Method of administration VIZAMYL is for intravenous use.
The activity of flutemetamol (18F) has to be measured with a dose calibrator immediately prior to injection. 5 cm or less) minimises the potential for adsorption of the active substance to the catheter. VIZAMYL is for multidose use. It must not be diluted.
The dose is administered by intravenous bolus injection within approximately 40 seconds. 9%) solution for injection to ensure full delivery of the dose. The injection of flutemetamol (18F) must be intravenous in order to avoid irradiation as a result of local extravasation, as well as imaging artefacts.
Image acquisition VIZAMYL images should be acquired starting 90 minutes after injection, using a PET scanner in 3D mode with appropriate data corrections. Position the patient supine with the patient’s brain (including the cerebellum) within a single field of view.
The patient’s head should be tilted so that the anterior commissure-posterior commissure (ACPC) plane is at right angles to the bore-axis of the PET scanner with the head positioned in a suitable head support. Reducing head movement with tape or other flexible head restraints may be employed.
1. 4
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It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Iterative or filtered back projection reconstruction is recommended with a slice thickness of 2 to 4 mm, and an axial matrix size of 128 x 128 with pixel sizes of approximately 2 mm. Where a post- smoothing filter may be applied with a full width half maximum (FWHM) of not more than 5 mm, the filter FWHM should be chosen to optimize the signal-to-noise ratio while preserving the sharpness of the reconstructed image.
The scan duration should typically be 20 minutes. 1. 4 Special warnings and precautions for use Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary.
To enable immediate action in emergencies the necessary medicinal products and equipment such as endotracheal tube and ventilator must be readily available. Individual benefit/risk justification For each patient, the radiation exposure must be justified by the likely benefit.
The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information. Renal /Hepatic impairment Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
Flutemetamol (18F) is excreted largely through the hepatobiliary system and patients with hepatic impairment have the potential of increased radiation exposure. 2. 1. Interpretation of VIZAMYL images VIZAMYL images should only be interpreted by readers trained in the interpretation of PET images with flutemetamol (18F).
A negative scan indicates none or a sparse density of cortical β-amyloid neuritic plaques. A positive scan indicates a moderate to frequent density. Image interpretation errors in the estimation of brain β-amyloid neuritic plaque density, including false negatives and false positives, have been observed.
PET images should be read using a Sokoloff, Rainbow or Spectrum colour scale. The reader should compare the cortical grey matter signal intensity to the maximum white matter signal intensity. The images should be viewed in a systematic manner (Figure 1) starting at the level of pons (p) and scrolling up through - The frontal lobes and anterior cingulate (f, ac, axial review) - Posterior cingulate and precuneus (pc, sagittal review) - Temporo-parietal aspects including Insula (in, axial review and tp-in, coronal review) - Lateral temporal lobes (lt, axial review) - Striatal region (s, axial review) Interpretation of the images is performed visually by comparing the activity in cortical grey matter with activity in adjacent cortical white matter.
e. distinctly lower signal intensity compared with adjacent white matter and similar in intensity to the grey matter-rich regions of the cerebellum). Signal will not be completely absent in grey matter regions of the images, as white matter binding in adjacent regions will bleed into the grey matter regions due to PET partial volume resolution effects.
, approximately at the same or higher signal intensity as adjacent white matter and greater than the grey matter-rich regions of the […]