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Amyvid is a brand name for Florbetapir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: This medicinal product is for diagnostic use only. Amyvid is a radiopharmaceutical 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 causes of cognitive…
Verbatim from this product's EMA label. Tap a section to expand.
A PET scan with florbetapir (18F) should be requested by physicians skilled in the clinical management of neurodegenerative disorders. Amyvid images should only be interpreted by readers trained in the interpretation of PET images with florbetapir (18F).
A recent co-registered computed tomography (CT) scan or magnetic resonance (MR) 3 imaging of the patient to get 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 safety profile of Amyvid is based on its administrations to 2,105 subjects in clinical trials. Tabulated list of adverse reactions Frequencies are defined as 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); not known (cannot be estimated from the available data).
While they may in reality occur at lower frequencies than indicated below, the size of the source database did not allow for the assignment of frequency categories lower than the category “uncommon” (≥1/1,000 to <1/100). System organ class Common Uncommon Nervous system disorders Headache Dysgeusia Vascular disorders Flushing Gastrointestinal disorders Nausea Skin and subcutaneous tissue disorders Pruritus Urticaria General disorders and administration site conditions Injection site reactiona Infusion site rash aInjection site reaction includes injection site haemorrhage, injection site irritation, and injection site pain 8 Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
As the effective dose is 7 mSv when the recommended activity of 370 MBq of florbetapir (18F) is administered, these adverse reactions are expected to occur with low probability. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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.
4. Image interpretation). Posology The recommended activity for an adult weighing 70 kg is 370 MBq florbetapir (18F). The volume of the injection should not be less than 1 mL and not exceed 10 mL. Special populations Elderly No dose adjustment is recommended based on age.
4). Extensive dose-range and adjustment studies with the medicinal product in normal and special populations have not been performed. The pharmacokinetics of florbetapir (18F) in patients with renal or hepatic impairment have not been characterised.
Paediatric population There is no relevant use of Amyvid in the paediatric population. Method of administration Amyvid is for intravenous use and multidose use. The activity of florbetapir (18F) has to be measured with an activimeter (dose calibrator) immediately prior to injection.
9%) solution for injection to ensure full delivery of the dose. Injection of florbetapir (18F) through a short intravenous catheter (approximately 4 cm or less) minimises the potential for adsorption of the active substance to the catheter.
The injection of florbetapir (18F) must be intravenous in order to avoid irradiation as a result of local extravasation, as well as imaging artefacts. Image acquisition A 10 minute PET image should be acquired starting approximately 30 to 50 minutes after intravenous injection of Amyvid.
Patients should be supine with the head positioned to centre the brain, including the cerebellum, in the PET scanner field of view. Reducing head movement with tape or other flexible head restraints may be employed. 0 mm. 1. 4 Special warnings and precautions for use Limitations of use A positive scan does not independently establish a diagnosis of AD or other cognitive disorder since neuritic plaque deposition in grey matter may be present in asymptomatic elderly and some neurodegenerative dementias (Alzheimer’s disease, Lewy body dementia, Parkinson’s disease dementia).
1. 4
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1. 1). Some scans may be difficult to interpret due to image noise, atrophy with a thinned cortical ribbon, or image blur, which could lead to interpretation errors. For cases in which there is uncertainty about the location of grey matter and of the grey/white matter border on the PET scan, and a co-registered recent CT or MR image is available, the interpreter should examine the fused PET-CT or PET-MR image to clarify the relationship of the PET radioactivity and the grey matter anatomy.
2). Examination of sagittal images and co-registered CT or MR images could help to distinguish occipital bone from occipital grey matter. Individual benefit/risk justification For each patient, the radiation exposure must be justifiable by the likely benefit.
The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information. Renal impairment and hepatic impairment Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
2). 1. Interpretation of Amyvid images Amyvid images should only be interpreted by readers trained in the interpretation of PET images with florbetapir (18F). A negative scan indicates sparse or no density of cortical β-amyloid plaques.
A positive scan indicates moderate to frequent density. Image interpretation errors in the estimation of brain β-amyloid neuritic plaque density, including false negatives, have been observed. Review of images should be primarily in the transaxial orientation with access as needed to the sagittal and coronal planes.
It is recommended that review of images include all transaxial slices of the brain using a black-white scale with the maximum intensity of the scale set to the maximum intensity of all brain pixels. Interpretation of the image as negative or positive is made by visually comparing the activity in cortical grey matter with activity in adjacent white matter (see Figure 1).
5 Negative scans have more activity in white matter than in grey matter, creating clear grey-white contrast. Positive scans will have either: a) Two or more brain areas (each larger than a single cortical gyrus) in which there is reduced or absent grey-white contrast.
This is the most common appearance of a positive scan; or b) One or more areas in which grey matter activity is intense and clearly exceeds activity in adjacent white matter.
Figure 1:
Amyvid PET cases showing examples of negative scans (top two rows) and positive scans (bottom two rows). Left to right panels show sagittal, coronal, and transverse PET image slices. Final panel to right shows enlarged picture of the brain area in the box.
The top two arrows are pointing to normal preserved grey-white contrast with the cortical activity less than the adjacent white matter. The bottom two arrows indicate areas of decreased grey-white contrast with increased cortical […]