Brand Name
Tauvid
Generic Name
Flortaucipir F-18
View Brand Information FDA approval date: July 01, 2022
Form: Injection
What is Tauvid (Flortaucipir F-18)?
TAUVID is indicated for use with positron emission tomography imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease . TAUVID is a radioactive diagnostic agent indicated for positron emission tomography imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease . Limitations of Use TAUVID is not indicated for use in the evaluation of patients for chronic traumatic encephalopathy . ( 1.
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Brand Information
TAUVID (Flortaucipir F-18)
1INDICATIONS AND USAGE
TAUVID is indicated for use with positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD).
2DOSAGE FORMS AND STRENGTHS
Injection: clear, colorless solution in a 50 mL or 100 mL multiple-dose vial containing 300 MBq/mL to 3,700 MBq/mL (8.1 mCi/mL to 100 mCi/mL) flortaucipir F 18 at the end of synthesis.
3CONTRAINDICATIONS
None.
4CLINICAL STUDIES
The performance of TAUVID imaging to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) was evaluated in two clinical studies: Study 1 (NCT02516046) and Study 2 (NCT03901092). In each study, TAUVID imaging was interpreted by 5 independent readers who were blinded to clinical information. Readers interpreted TAUVID imaging as positive or negative
Study 1 enrolled 156 terminally ill patients who agreed to undergo TAUVID imaging and to participate in a postmortem brain donation program. In 64 of these patients, reader interpretation of the TAUVID scan was compared to tau pathology based on scoring provided by independent pathologists, who evaluated the density and distribution of NFTs in the post-mortem brain (see
Image reader performance for distinguishing B3 (positive) from B0-B2 (negative) tau pathology is shown in
The performance of the five TAUVID readers for sensitivity (95% CI) ranged from 92% (80, 97) to 100% (91, 100) and for specificity (95% CI) ranged from 52% (34, 70) to 92% (75, 98). Exploratory analysis evaluated how the same TAUVID interpretations distinguished B2-B3 from B0-B1 tau pathology, a threshold used in integrating tau and amyloid pathology for the neuropathological diagnosis of AD. In this analysis, the performance of the five TAUVID readers for sensitivity (95% CI) ranged from 68% (55, 79) to 86% (74, 93) and for specificity (95% CI) ranged from 63% (31, 86) to 100% (68, 100)
Study 2 included the same terminally ill patients as in Study 1 (plus 18 additional terminally ill patients) and 159 patients with cognitive impairment being evaluated for AD (the indicated population). Inter-reader agreement for five new TAUVID readers was evaluated using Fleiss' kappa statistic (95% CI) and found to be 0.87 (0.83, 0.91) across all 241 patients. Exploratory analysis evaluated inter-reader agreement in two subgroups. In this analysis, Fleiss' kappa (95% CI) was 0.82 (0.75, 0.88) in the terminally ill patients and 0.90 (0.85, 0.95) in the indicated population.
5PATIENT COUNSELING INFORMATION
Radiation Risk
Advise patients of the radiation risk of TAUVID
Pregnancy
Advise a pregnant woman of the potential risks of fetal exposure to radiation doses with TAUVID
Lactation
Advise a lactating woman to avoid breastfeeding for 4 hours after TAUVID administration in order to minimize radiation exposure to a breastfed infant
Manufactured for Avid Radiopharmaceuticals, a wholly-owned subsidiary of Eli Lilly and Company, Philadelphia, PA 19104
Copyright © 2020, 2024, Eli Lilly and Company. All rights reserved.
TAU-0003-USPI-20240205