Flortaucipir (18F)

What is Flortaucipir (18F)?

• Flortaucipir (18F) (TAUVID) is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging of the brain.

What are the uses of this medicine?

• This medicine 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).

How does this medicine 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients if:

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

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• 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 .
• Use waterproof gloves and effective shielding, including syringe shields, when preparing and handling TAUVID.

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.
• Initiate imaging approximately 80 minutes after drug administration.

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.
• 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. Diluted product should be used within 3 hours of dilution and prior to product expiry.
• Assay the dose in a suitable dose calibrator prior to administration.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 300 MBq/mL to 1,900 MBq/mL (8.1 mCi/mL to 51 mCi/mL) of flortaucipir F 18 injection in a multiple-dose vial.

This medicine is available in fallowing brand namesː

• TAUVID

What side effects can this medication cause?

Common possible side effects of this medicine include:

• headache
• injection site pain
• increased blood pressure

What special precautions should I follow?

• Ensure safe drug handling to protect patients and health care workers from unintentional radiation exposure.
• The safety and effectiveness of TAUVID have not been established for patients being evaluated for Chronic Traumatic Encephalopathy.
• Consider additional evaluation to confirm the absence of AD pathology in patients with a negative TAUVID scan.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• The safety and effectiveness of TAUVID in pediatric patients have not been established.

What should I know about storage and disposal of this medication?

• Store TAUVID at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .
• TAUVID does not contain a preservative.
• Store TAUVID upright in a shielding container.
• The expiration date and time are provided on the container label.
• Use TAUVID within the labeled expiration.

Handling

• This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

• Dailymed label info on Flortaucipir (18F)
• FDA Flortaucipir (18F)

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