Flortaucipir f-18

FDA label, Eli Lilly and Company, intravenous, effective 2025-12-30. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

Table 1: Estimated Radiation Absorbed Dose After a TAUVID Injection
a Assumed radiation weighting factor, wr, (formerly defined as quality factor, Q) of 1 for conversion of absorbed dose (Gray or rads) to dose equivalent (Sieverts or rem) for F 18. To obtain radiation absorbed dose in rad/mCi from above table, multiply the dose in μGy/MBq by 0.0037 (e.g., 14 μGy/MBq x 0.0037 = 0.0518 rad/mCi).
Organ/TissueMean Absorbed Dose Per Unit Administered Activity (μGy/MBq)
Adrenal glands 14
Brain 8
Breasts 7
Gallbladder wall 38
Lower large intestine wall 35
Small intestine wall 85
Stomach wall 13
Upper large intestine wall 96
Heart wall 30
Kidneys 40
Liver 57
Lungs 34
Muscle 9
Ovaries 21
Pancreas 14
Red bone marrow 10
Osteogenic cells 12
Skin 6
Spleen 10
Testes 7
Thymus gland 9
Thyroid 7
Urinary bladder wall 38
Uterus 18
Total body 12
Effective dose (μSv/MBq)a24

Preparation and administration

Prepare this dose

Your numbers for flortaucipir f-18. Take vial strength, diluent, and limits from the label below.

Basis

Enter a dose to see draw volume, final concentration, and rates.

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] . 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 4 hours of dilution and prior to product expiry. Assay the dose in a suitable dose calibrator prior to administration. Post-Administration Instructions Follow the TAUVID injection with an intravenous flush of 0.9% Sodium Chloride injection, USP. Dispose of any unused TAUVID in compliance with applicable regulations.

Preparation for Image Interpretation Before interpreting the image, review the brain to determine the lobar anatomy. Interpret the images by first evaluating the temporal lobes, followed by occipital, parietal, and frontal lobes bilaterally. To evaluate the temporal lobes, subdivide them into four quadrants by placing the horizontal crosshair immediately posterior to the brainstem nuclei and then scrolling inferiorly to place the vertical crosshair through the widest portion of the temporal pole, thus obtaining the anterolateral temporal (ALT), anterior mesial temporal (AMT), posterolateral temporal (PLT) and posterior mesial temporal (PMT) quadrants.

See Figure 2 for an example (the left and right image panels show the same scan in two different color scales). Figure 2: Temporal Lobe Quadrants Figure 2

Contraindications

None. None. ( 4 )

Pregnancy and lactation

Pregnancy

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.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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Therapeutic equivalence (Orange Book)

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