Flortaucipir F 18

Flortaucipir F 18 is an imaging agent 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's disease (AD).

• Flortaucipir F 18 is available under the following different brand names: Tauvid

Common side effects of Flortaucipir F 18 include:

• headache
• injection site pain
• increased blood pressure

Serious side effects of Flortaucipir F 18 include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat

Rare side effects of Flortaucipir F 18 include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 300-1,900 MBq/mL (8.1-51 mCi/mL) in 30 mL multidose vials
• At the time of administration, 370 MBq (10 mCi) are contained in up to 10 mL solution for injection
• Tau neurofibrillary tangles estimation

Adult dosage

• 370 MBq (10 mCi) IV bolus in a total volume of 10 mL and below
• Image acquisition
  • Starting approximately 80 min after IV bolus, obtain a 20-min PET image with the patient supine
  • Position the 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 the images in the transverse, sagittal, and coronal planes
  • Reorient the 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 the imaging independently of the patient’s clinical features and other imaging
  • Interpret the 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 the 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 the scans that have isolated or noncontiguous, small foci in any region with caution
• 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

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Flortaucipir F 18 has no noted severe interactions with any other drugs.
• Flortaucipir F 18 has no noted serious interactions with any other drugs.
• Flortaucipir F 18 has no noted moderate interactions with any other drugs.
• Flortaucipir F 18 has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Flortaucipir F 18?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Flortaucipir F 18?”

Cautions

• Safety and efficacy not established for patients being evaluated for chronic traumatic encephalopathy
• Risk for misdiagnosis
  • Flortaucipir F 18 does not target beta-amyloid, 1 of 2 required components of the neuropathological diagnosis of AD
  • The imaging agent’s 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
• Negative scan
  • NFTs may be present at levels that qualify for neuropathological diagnosis of AD (B2 tau pathology in the presence of at least moderate levels of cortical amyloid pathology)
  • Consider additional evaluation to confirm the 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 the neocortex should contribute to the interpretation of a positive scan
• Radiation risk
  • Diagnostic radiopharmaceuticals expose patients to radiation
  • Radiation exposure is associated with a dose-dependent increased risk for cancer
  • Ensure safe handling and preparation procedures to protect patients and healthcare workers from unintentional radiation exposure

Pregnancy and Lactation

• All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose
• Advise pregnant women of the potential risks for fetal exposure to radiation
• Not likely to be used in women of reproductive age
• No data available for use in pregnant women
• 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 lactating women to avoid breastfeeding for 4 hours after administration to minimize radiation exposure to a breastfed infant