Flortaucipir: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: April 10, 2026🚩 Report this page

Flortaucipir

Active ingredient

Sold as Tauvid

GB MHRAEU EMA

Drug class: -
Availability: See label
Markets covered: 2
Products on record: 3

Overview

Flortaucipir is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	2	April 10, 2026
EU European Union	EMA	1	January 16, 2026

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised April 10, 2026[1]

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 impairment who are being evaluated for AD.
Flortaucipir (18F) is an adjunct to clinical and other diagnostic evaluations.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised January 16, 2026[2]

This medicinal product is for diagnostic use only. Flortaucipir (18F) is a radiopharmaceutical indicated for positron emission tomography (PET) imaging of the brain to assess the neocortical distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD).
Flortaucipir (18F) is an adjunct to clinical and other diagnostic evaluations. 1.

How to take

Sources & citations

[1]MHRA (UK) · PLGB148950329 · revised April 10, 2026
[2]European Medicines Agency · EMEA/H/C/006064 · revised January 16, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised April 10, 2026[1]

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.

GBOfficial regulatory label· Warnings and precautions· revised April 10, 2026[1]

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.
• 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.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised January 16, 2026[2]

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.

EUOfficial regulatory label· Warnings and precautions· revised January 16, 2026[2]

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.
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.
• 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.

This is not medical advice. Consult a qualified healthcare professional.