Flortaucipir

Flortaucipir F 18 binds to aggregated tau protein. In the brains of patients with AD, tau aggregates combine to form NFTs, one of two components required for the neuropathological diagnosis of AD.

• 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). TAUVID is a radioactive diagnostic agent indicated for 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).ICD-10: G30.9

• None. None.contraindicated

Recommended dose is 370 MBq (10 mCi), administered as a bolus intravenous injection. ( 2.2 ) Initiate imaging approximately 80 minutes after drug administration. ( 2.3 ) See full prescribing information for additional preparation, administration, imaging, and radiation dosimetry information. ( 2 ) 2.1 Radiation Safety - Drug Handling TAUVID is a radioactive drug. Only authorized persons qualified by training and experience should receive, use, and administer TAUVID. Handle TAUVID with appropriate safety measures to minimize radiation exposure during administration [see Warnings and Precautions ( 5.3 )] . Use waterproof gloves and effective shielding, including syringe shields, when preparing and handling TAUVID. 2.2 Recommended Dosage and Administration Instructions Recommended Dose The recommended amount of radioactivity to be administered for PET imaging is 370 MBq (10 mCi), administered as an intravenous bolus injection in a total volume of 10 mL or less. Preparation and Administration Assessment of pregnancy status is recommended in females of reproductive potential before administering TAUVID. Use aseptic technique and radiation shielding during the preparation and administration of TAUVID [see Dosage and Administration ( 2.1 )] . Visually inspect the radiopharmaceutical solution prior to administration. Do not use it if it contains particulate matter or if it is discolored (TAUVID is a clear, colorless solution). TAUVID may be diluted aseptically with 0.9% Sodium Chloride Injection to a maximum dilution of 1:5 by the end-user.

Risk of Misdiagnosis in Patients Evaluated for Alzheimer's disease : Consider additional evaluation to confirm the absence of AD pathology in patients with a negative TAUVID scan. ( 2.6 , 5.1 ) Risk of Chronic Traumatic Encephalopathy Misdiagnosis : The safety and effectiveness of TAUVID have not been established for patients being evaluated for CTE. ( 1 , 5.2 ) Radiation Risk : Ensure safe drug handling to protect patients and health care workers from unintentional radiation exposure. ( 2.1 , 5.3 ) 5.1 Risk of Misdiagnosis in Patients Evaluated for Alzheimer's disease TAUVID does not target β-amyloid, one of two required components of the neuropathological diagnosis of AD. TAUVID performance for detecting tau pathology was assessed in terminally ill patients, the majority of whom had AD dementia with B3 level NFT pathology. TAUVID performance for detecting tau pathology may be lower in patients in earlier stages of the pathological spectrum [see Clinical Studies ( 14 )] . Negative TAUVID Scan NFTs may be present at levels that qualify for the neuropathological diagnosis of AD (B2 tau pathology in the presence of at least moderate levels of cortical amyloid pathology) in patients with a negative TAUVID scan. Consider additional evaluation to confirm the absence of AD pathology in patients with a negative TAUVID scan. False Positive TAUVID Scan Small foci of noncontiguous tracer uptake may lead to a false positive TAUVID scan. Only uptake of tracer in the neocortex should contribute to the interpretation of a positive TAUVID scan [see Dosage and Administration ( 2.4 )] .

Most common adverse reactions (frequency ≥ 0.5%) were headache, injection site pain, and increased blood pressure. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies, 1,921 study participants were exposed to TAUVID [see Clinical Studies ( 14 )] . In these studies, 885 study participants received 240 MBq of TAUVID (about 65% of the recommended dose) and 1,036 study participants received 370 MBq of TAUVID (the recommended dose). The adverse reactions reported in ≥ 0.5% of study participants are shown in Table 2 . Table 2: Adverse Reactions with a Frequency ≥0.5% in Adults Who Received TAUVID in Clinical Trials (n = 1,921) Adverse Reaction n (%) Headache 26 (1.4%) Injection site pain 23 (1.2%) Increased blood pressure 15 (0.8%) Adverse reactions with a frequency <0.5% in adults who received TAUVID in clinical trials include: Nervous system disorders: dysgeusia

Lactation : Interrupt breastfeeding. Advise a lactating woman to avoid breastfeeding for 4 hours after TAUVID administration. ( 8.2 ) 8.1 Pregnancy Risk Summary All radiopharmaceuticals, including TAUVID, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of radiation dose. Advise a pregnant woman of the potential risks of fetal exposure to radiation doses with administration of TAUVID. TAUVID is not likely to be used in females of reproductive age. There are no available data on TAUVID use in pregnant women. No animal reproduction studies using flortaucipir F 18 have been conducted to evaluate its effect on female reproduction and embryo-fetal development. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. 8.2 Lactation Risk Summary There are no data on the presence of flortaucipir F 18 in human milk, or its effects on the breastfed infant or milk production. Lactation studies have not been conducted in animals.

Metabolism

After intravenous administration of TAUVID, flortaucipir F 18 was distributed throughout the body with less than 10% of the injected F 18 radioactivity present in the blood by 5 minutes following administration, and less than 5% present in the blood by 10 minutes after administration. The residual F 18 in circulation during the 80-minute to 100-minute imaging window was approximately 28% to 34% parent, with the remainder being metabolites.

• May 28, 2020NDANDA212123Avid Radiopharms Inc

1. 1Incorrect Dose Administered1100%

The 10 most recently updated of 39 ClinicalTrials.gov registrations naming Flortaucipir as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• F 18 T807 Tau PET Imaging of Alzheimer's Disease
  Recruiting · Observational · 900 enrolled · Tammie L. S. Benzinger, MD, PhD
  NCT02414347updated 2026-06-08
• Neuroimaging in Healthy Aging and Senile Dementia (HASD_IND)
  Recruiting · Observational · 650 enrolled · Tammie L. S. Benzinger, MD, PhD
  NCT04579120updated 2026-06-08
• Depression and Driving
  Recruiting · Observational · 150 enrolled · Washington University School of Medicine
  NCT05446805updated 2026-06-08
• Alzheimer's Disease Neuroimaging Initiative 4
  Enrolling by invitation · Observational · 1,500 enrolled · University of Southern California
  NCT05617014updated 2026-06-05
• A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy
  Recruiting · Phase 1 · Interventional · 18 enrolled · Eli Radiopharma
  NCT07580703updated 2026-05-14
• NFL LONG Prospective Study
  Active not recruiting · Phase 1 · Interventional · 250 enrolled · University of North Carolina, Chapel Hill
  NCT04263337updated 2026-04-22
• A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
  Recruiting · Phase 1 · Interventional · 48 enrolled · Eli Lilly and Company
  NCT06297590updated 2026-04-20
• Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia
  Recruiting · Observational · 1,200 enrolled · GAP Innovations, PBC
  NCT06584357updated 2026-04-15
• Longitudinal Imaging Biomarkers of Disease Progression in DLB
  Enrolling by invitation · Phase 4 · Interventional · 135 enrolled · Kejal Kantarci
  NCT03582488updated 2026-03-19
• Longitudinal Early-onset Alzheimer's Disease Study Protocol
  Recruiting · Observational · 850 enrolled · Indiana University
  NCT03507257updated 2026-02-18

Frequently asked questions

How does Flortaucipir work?

Flortaucipir F 18 binds to aggregated tau protein. In the brains of patients with AD, tau aggregates combine to form NFTs, one of two components required for the neuropathological diagnosis of AD.

What is Flortaucipir used for?

According to FDA labeling, Flortaucipir carries indications including: 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). TAUVID is a radioactive diagnostic agent indicated for 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).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Flortaucipir?

Flortaucipir is classified as Positron Emitting Activity.

What are the contraindications for Flortaucipir?

Flortaucipir labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.