Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 300-1,900 MBq/mL (8.1-51 mCi/mL) in 30 mL multidose vials
- At time of administration, 370 MBq (10 mCi) are contained in up to 10 mL solution for injection
Tau Neurofibrillary Tangles Estimation
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 adults with cognitive impairment who are being evaluated for Alzheimer disease (AD)
370 MBq (10 mCi) IV bolus in a total volume of ≤10 mL
Image acquisition
- Starting ~80 min after IV bolus, obtain a 20-min PET image with the patient supine
- Position head to center the brain (including the cerebellum) in the PET scanner field of view
- Tape or other flexible head restraints may be used to reduce head movement
Image display
- 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
Image interpretation
- Interpret imaging independently of the patient’s clinical features and other imaging
- Interpret images based on the pattern and density of the radioactive signal within the neocortical gray matter (not within white matter or in regions outside of the brain)
- Only uptake of tracer in the neocortical grey matter regions should contribute to scan interpretation
- Off-target binding may be seen in the choroid plexus, striatum, and brainstem nuclei
- Small foci of noncontiguous tracer uptake may lead to false-positive interpretation
- Interpret scans that have isolated or noncontiguous, small foci in any region with caution
- See prescribing information for additional information
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Positive scan
- Scan shows increased neocortical activity in posterolateral temporal (PLT), occipital, or parietal/precuneus region(s), with or without frontal activity
-
Negative scan
- Scan shows no increased neocortical activity, or shows increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions
Dosing Considerations
Assess pregnancy status in females of reproductive potential before administration
Limitation of use
- Not for use in the evaluation of patients for chronic traumatic encephalopathy (CTE)
Safety and efficacy not established
Adverse Effects
1-10%
Headache (1.4%)
Injection site pain (1.2%)
<1%
Increased blood pressure (0.8%)
Warnings
Contraindications
None
Cautions
Safety and efficacy not established for patients being evaluated for CTE
Risk for misdiagnosis
- Imaging agent does not target beta-amyloid, 1 of 2 required components of the neuropathological diagnosis of AD
- Performance for detecting tau pathology was assessed in terminally ill patients, the majority of whom had AD dementia with B3 level NFT pathology
- Performance for detecting tau pathology may be lower in patients in earlier stages of the pathological spectrum
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Negative scan
- NFTs may be present at levels that qualify for neuropathological diagnosis of AD (B2 tau pathology in presence of at least moderate levels of cortical amyloid pathology)
- Consider additional evaluation to confirm absence of AD pathology
-
False-positive scan
- Small foci of noncontiguous tracer uptake may lead to a false-positive scan
- Only uptake of tracer in neocortex should contribute to interpretation of a positive scan
Radiation risk
- Diagnostic radiopharmaceuticals 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
Pregnancy & Lactation
Pregnancy
All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of radiation dose
Advise pregnant females of potential risks of fetal exposure to radiation
Not likely to be used in females of reproductive age
No data available use in pregnant females
Lactation
There are no data on the presence of flortaucipir F 18 in human milk, or its effects on breastfed infants or milk production
Advise a lactating females to avoid breastfeeding for 4 hr after administration in order to minimize radiation exposure to a breastfed infant
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Flortaucipir F 18 binds to aggregated tau protein
In brains of patients with AD, tau aggregates combine to form NFTs, 1 of 2 components required for neuropathological diagnosis of AD
Distribution
Distributed throughout the body with <10% of the injected flortaucipir F 18 radioactivity present in the blood by 5 min following administration, and <5% present in the blood by 10 min after administration
Elimination
Clearance: Primarily by hepatobiliary and renal excretion
Administration
IV Preparation
Radioactive drug
Only authorized persons qualified by training and experience should receive, use, or administer injection
Use aseptic technique and radiation shielding during preparation and administration
Visually inspect solution before administration; do not use it if it contains particulate matter or if it is discolored (solution appears clear and colorless)
Dilute aseptically with 0.9% NaCl to a maximum dilution of 1:5 by the end-user
Use diluted product within 3 hr of dilution and prior to product expiration
Assay dose in a suitable dose calibrator before administration
IV Administration
Follow injection with IV flush of 0.9% NaCl
Dispose of any unused drug in compliance with applicable regulations
Storage
Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
Does not contain a preservative
Store upright in a shielding container
Expiration date and time are provided on the container label
Use within the labeled expiration
Images
Formulary
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