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TAUVID is a brand name for Flortaucipir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: This medicinal product is for diagnostic use only. Flortaucipir (18F) is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of the brain to estimate the density and distribution of the aggregated tau neurofibrillary tangles (NFTs) of Alzheimer’s disease (AD) in adult patients with cognitive…
Verbatim from this product's MHRA label. Tap a section to expand.
A PET scan with flortaucipir (18F) should be requested by physicians skilled in the clinical management of neurodegenerative disorders. Tauvid images should only be interpreted by readers trained in the interpretation of PET images with flortaucipir (18F).
Posology The recommended single intravenous dose for flortaucipir (18F) injection is 370 MBq (10 mCi) of flortaucipir (18F) in a dose volume of ≤10 mL. Special populations Elderly population No dose adjustment is recommended based on age.
4). Paediatric population There is no relevant use of flortaucipir (18F) in the paediatric population. Method of administration Flortaucipir (18F) is for intravenous use and multidose use. The radiopharmaceutical dose should be measured by a suitable radioactivity measurement system and inspected for particulate matter or discolouration prior to administration.
9 %) solution for injection to ensure full delivery of the dose. 9 %) solution for injection. Only authorised persons qualified by training and experience should receive, use and administer flortaucipir (18F). Use appropriate safety measures to minimize unnecessary radiation exposure to clinical personnel, patients, and the public.
Image acquisition A 20 minute PET image should be acquired starting approximately 80 minutes after intravenous injection of flortaucipir (18F). 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.
Summary of the safety profile The safety profile of flortaucipir (18F) is based on its administrations to 4 652 subjects in clinical trials. Tabulated list of adverse reactions Frequencies are defined as uncommon (≥ 1/1 000 to < 1/100).
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 Adverse reaction and frequency Nervous system disorders Uncommon: headache Uncommon: dysgeusia General disorders and administration site conditions Uncommon: injection site pain Investigations Uncommon: blood pressure increaseda aIncludes hypertension, blood pressure systolic increased, and hypertensive urgency Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
7 mSv when the maximal recommended activity of 370 MBq is administered, these adverse reactions are expected to occur with a 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
Limitations of use Flortaucipir (18F) binds selectively to AD-type neurofibrillary tangles. The safety and effectiveness of flortaucipir (18F) to assess the distribution of tau resulting from chronic traumatic encephalopathy (CTE), non-AD type dementias, or neurodegenerative conditions have not been established.
Renal and hepatic impairment Flortaucipir (18F) is excreted through the hepatobiliary and renal systems. 2). Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
65-fold the measured cerebellar average). 65-fold threshold. Examine the posterolateral temporal (PLT), occipital, parietal, and frontal regions bilaterally. Neocortical activity in either hemisphere contributes to image interpretation.
Activity in white matter or regions outside the brain does not contribute to image interpretation. To help identify the PLT region, consider subdividing the temporal lobe into four quadrants as instructed below. Activity in the anterior and medial temporal lobe does not contribute to image interpretation of an AD flortaucipir (18F) pattern.
Image display and orientation Display images in the transverse, sagittal, and coronal planes. Reorient images to remove head tilt in the transverse and coronal plane. Use a sagittal slice just off the midline to align the inferior frontal and inferior occipital poles in the horizontal plane.
Select and adjust the colour scale To create a visual threshold for positivity: • Draw a region of interest around the cerebellum in the transverse plane. • Select the plane to go through the cerebellum at the maximum cross-sectional area of the cerebellum.
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• Record the mean activity or cerebellar counts (MCC). The region of interest should be drawn with the scan in grey scale and in the transverse plane as seen in the example in Figure 1.
Figure 1:
Example of Cerebellar Region of Interest • Select a colour scale for image display that has a rapid transition between two distinct colours in the general range of 25 % to 60 % of maximum intensity. • Set the upper contrast value (UCV) of the colour scale.
65) x (100 % / % level of colour transition) Preparation for image interpretation • Before interpreting the image, review the brain to determine the lobar anatomy. Interpret the images by first evaluating the temporal lobes, followed by occipital, parietal, and frontal lobes bilaterally.
• To evaluate the temporal lobes, subdivide them into four quadrants by placing the horizontal crosshair immediately posterior to the brainstem nuclei and then scrolling inferiorly to place the vertical crosshair through the widest portion of the temporal pole, thus obtaining the anterolateral temporal (ALT), anterior mesial temporal (AMT), posterolateral temporal (PLT) and posterior mesial temporal (PMT) quadrants.
See Figure 2 for an example (the left and right image panels show the same scan in two different colour scales).
Figure 2:
Temporal Lobe Quadrants Colour Scale 1 Colour Scale 2 Image interpretation errors can occur with flortaucipir (18F) imaging. Interpret the PET flortaucipir (18F) images based upon the pattern and density of the radioactive signal within the neocortical grey matter (not within white matter or in regions outside of the brain).
Only uptake of tracer in the neocortical grey matter regions should contribute to scan interpretation. Off-target binding may be seen in the choroid plexus, striatum, and brainstem nuclei. Small foci of non-contiguous tracer uptake may lead to false positive interpretation.
Interpret scans that have isolated or non-contiguous, small foci in any region with caution. Some scans may be difficult to interpret due to image noise or motion artifact. For cases where there is uncertainty as to the location of neocortical uptake, use co-registered anatomical imaging to improve localisation of uptake.
1). In patients with an appropriate clinical workup, a scan indicating the presence of B3 NFTs is supportive of an AD diagnosis. Neocortical activity in either hemisphere can contribute to identification of the pattern. AD flortaucipir (18F) patterns fall into one of two categories: • Moderate AD flortaucipir (18F) pattern (Figure 3, rows 1 and 2): increased neocortical activity in the PLT or occipital region(s).
• Advanced AD flortaucipir (18F) pattern (Figure 3, rows 3, 4, and 5): increased neocortical activity in the parietal/precuneus region(s), or increased activity in the frontal region(s) accompanied by increases in the PLT, parietal, or occipital region(s).
Figure 3.
AD Diagnostic Scan Examples Negative flortaucipir (18F) pattern:
Scans without increased neocortical activity, or with increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions represent […]