Tauvid

A PET scan with flortaucipir (18F) should be requested by physicians skilled in the clinical management of neurodegenerative disorders. 4). Posology The recommended single intravenous dose is 370 MBq of flortaucipir (18F) in a dose volume of ≤ 10 mL for an adult weighing 70 kg.

Special populations Elderly No dose adjustment is recommended based on age. Renal and hepatic impairment Flortaucipir (18F) has not been studied in patients with current clinically significant renal or hepatic disease. 4). Paediatric population There is no relevant use of flortaucipir (18F) in the paediatric population in the indication of PET imaging of the brain to assess the neocortical distribution of aggregated tau NFTs for the evaluation of the presence of AD.

Method of administration Only authorised personnel qualified by training and experience should receive, store, dilute, and administer flortaucipir (18F). Flortaucipir (18F) should be used only in a designated nuclear medicine facility.

Flortaucipir (18F) is for intravenous use. Flortaucipir (18F) is presented as a multidose vial. 9 %) solution for injection to ensure full delivery of the dose. For instructions on dilution of the radiopharmaceutical before administration, see section 12.

4. 4 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. Reconstruction should include attenuation correction. A recent co-registered computed tomography (CT) scan or magnetic resonance (MR) imaging of the patient to get a fused PET-CT or PET-MR image is recommended for anatomic localisation.

5 %). Tabulated list of adverse reactions The safety profile of flortaucipir (18F) is based on 4 652 subjects receiving one or more injections in clinical trials. The adverse reactions are listed below by SOC (system organ class) and by frequency, most frequent reactions first, with the following guidelines: 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).

Table 1. Adverse reactions observed with flortaucipir (18F) System organ class Frequency and adverse reaction 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.

6 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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.

1). 1). , B2 level. 1). Flortaucipir (18F) performance for detecting tau pathology may be lower in patients in earlier stages of the pathological spectrum. Available data suggest that flortaucipir (18F) is not informative in amyloid-negative patients, therefore in these patients the use of flortaucipir (18F) is not recommended.

1). Flortaucipir (18F) binds 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.

Patient preparation The patient should be well hydrated before the start of the examination and urged to void as often as possible during the first hours after the examination in order to reduce radiation. After the procedure Close contact with infants and pregnant women should be restricted during the initial 4 hours following the injection.

5 Renal and hepatic impairment Flortaucipir (18F) is excreted through the hepatobiliary and renal systems. 2). Interpretation of flortaucipir (18F) images Tauvid images should only be interpreted by readers trained in the interpretation of PET images with flortaucipir (18F).

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.

g. meninges, bone) may be seen, but 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 may also be seen but it has not been established to be specific for AD and does not contribute to image interpretation of an AD flortaucipir (18F) pattern.

1.