About TAUVID


Routine clinical assessments alone are limited in their ability to accurately diagnose Alzheimer's disease, but the timely and accurate use of diagnostic tools can help facilitate appropriate patient management, treatment decisions, and resource planning.1-3

Brain PET scan image of three views
Brain PET scan image of three views
Brain PET scan image of three views

Example of a positive tau scan

About TAUVID


What is TAUVID?

TAUVID is a diagnostic PET imaging radiotracer that estimates density and distribution of aggregated tau neurofibrillary tangles (NFTs).

What are neurofibrillary tangles?

Neurofibrillary tangles are aggregates of hyperphosphorylated tau protein deposited in the brain.4

How is TAUVID useful?

Positron emission tomography (PET) with TAUVID has the potential to augment the diagnostic process and help confirm the underlying neuropathological changes of Alzheimer's disease (AD) previously only available at autopsy.
The results of a TAUVID scan, in conjunction with other diagnostic information, may contribute meaningfully to the assessment of patients being evaluated for Alzheimer's disease.5-6

TAUVID Availability and Resources

TAUVID is available in limited regions within the United States. For questions regarding TAUVID customer support resources, ordering, or availability in your local areas, please contact 1-800-LillyRX (1-800-545-5979).

References

  1. Relkin N. Screening and early diagnosis of dementia. N Am J Manag Care. 2000;6:S1111-S1124.
  2. Hill JW, Futterman F, Duttagupta S, et al. Alzheimer's disease and related dementias increase costs of comorbidities in managed Medicare. Neurology. 2002;58:62-70.
  3. Balasa M, Gelpi E, Antonell A, et al. Clinical features and APOE genotype of pathologically proven early-onset Alzheimer disease. Neurology. 2011;76:1720-1725.
  4. Hyman BT, Phelps CH, Beach TG, et al. National Institute on Aging-Alzheimer's Association guidelines for the neuropathologic assessment of Alzheimer's disease. Alzheimers Dement. 2012;8(1):1-13.
  5. Fleisher AS, Pontecorvo MJ, Devous MD Sr., et al, for the A16 investigators. Positron emission tomography imaging with [18F] flortaucipir and postmortem assessment of Alzheimer disease neuropathologic changes. JAMA Neurol. 2020; Published online April 27, 2020. Accessed October 8, 2020.
  6. TAUVID [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.

Indication

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).

Limitations of Use

TAUVID is not indicated for use in the evaluation of patients for chronic traumatic encephalopathy (CTE).

TAUVID for intravenous use is supplied in multidose vials containing 300-1900 MBq/mL flortaucipir F 18.

Important Safety Information

WARNINGS AND PRECAUTIONS

Risk of Misdiagnosis in Patients Evaluated for Alzheimer's disease (AD)
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 neurofibrillary tangle (NFT) pathology. TAUVID performance for detecting tau pathology may be lower in patients in earlier stages of the pathological spectrum.

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.

Risk of Chronic Traumatic Encephalopathy Misdiagnosis
The safety and effectiveness of TAUVID have not been established for patients being evaluated for CTE. Preliminary non-clinical and clinical investigations suggest differences in tau conformation and distribution may limit flortaucipir F 18 binding. Therefore, TAUVID is not indicated for detection of CTE.

Radiation Risk
Diagnostic radiopharmaceuticals, including TAUVID, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure.

ADVERSE REACTIONS
The most common adverse reactions reported in clinical trials were headache (1.4%), injection site pain (1.2%), and increased blood pressure (0.8%).

USE IN SPECIAL POPULATIONS

Pregnancy
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.

Lactation
Advise a lactating woman to avoid breastfeeding for 4 hours after TAUVID administration in order to minimize radiation exposure to a breastfed infant.

Please see Full Prescribing Information for TAUVID.

FT HCP ISI 28MAY2020