tauvid
Tauvid (Flortaucipir F-18) is a medication supplied as an injection, solution.
Flortaucipir F-18 · by Avid Radiopharms Inc
Key facts
- Active ingredient
- Flortaucipir F-18
- Form
- Injectable
- Strength
- Flortaucipir F-18 100ML (8.1-100mCi/ML) · Flortaucipir F-18 30ML (8.1-51mCi/ML) · Flortaucipir F-18 50ML (8.1-100mCi/ML) · Flortaucipir F-18 50ML (8.1-51mCi/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Avid Radiopharms Inc
- FDA application
- NDA212123
What is Tauvid?
From the FDA label:11.1 Chemical Characteristics TAUVID contains flortaucipir fluorine 18 (F 18). Chemically, flortaucipir F 18 is 7-(6-[F-18]fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole. The molecular weight is 262.27, the molecular formula is C 16 H 10 [ 18 F]N 3, and the structural formula is: TAUVID is a sterile, non-pyrogenic solution for intravenous injection. The clear, colorless solution free of visible particulate matter is supplied ready to use, and each milliliter contains up to 2 micrograms of flortaucipir and 300 to 3,700 MBq (8.1 to 100 mCi) flortaucipir F 18 at end of synthesis, 1.5 mg of L-cysteine hydrochloride monohydrate USP, 2.1 mg of dibasic sodium phosphate anhydrous USP, up to 55 of micrograms hydrogen chloride and 0.1 mL dehydrated alcohol in 0.9% sodium chloride injection USP. The pH of the solution is between 5.5 and 7.5. Structural Formula 11.2 Physical Characteristics TAUVID is radiolabeled with fluorine 18 (F 18), a cyclotron produced radionuclide that decays by positron emission to stable oxygen 18 with a half-life of 109.8 minutes. The principal photons useful for diagnostic imaging are the coincident pair of 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron ( Table 3 ). Table 3: Principal Radiation Produced from Decay of Fluorine 18 Radiation Energy Level (keV) Abundance (%) Positron 249.8 96.9 Gamma 511 193.5 11.3…
How to use
Recommended dose is 370 MBq (10 mCi), administered as a bolus intravenous injection. ( 2.2 ) Initiate imaging approximately 80 minutes after drug administration. ( 2.3 ) See full prescribing information for additional preparation, administration, imaging, and radiation dosimetry information. ( 2 ) 2.1 Radiation Safety - Drug Handling 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 [see Warnings and Precautions ( 5.3 )] . Use waterproof gloves and effective shielding, including syringe shields, when preparing and handling TAUVID. 2.2 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 ( 2.1 )] . Visually inspect the radiopharmaceutical solution prior to administration. Do not use it if it contains particulate matter or if it is…
Side effects
Most common adverse reactions (frequency ≥ 0.5%) were headache, injection site pain, and increased blood pressure. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies, 1,921 study participants were exposed to TAUVID [see Clinical Studies ( 14 )] . In these studies, 885 study participants received 240 MBq of TAUVID (about 65% of the recommended dose) and 1,036 study participants received 370 MBq of TAUVID (the recommended dose). The adverse reactions reported in ≥ 0.5% of study participants are shown in Table 2 . Table 2: Adverse Reactions with a Frequency ≥0.5% in Adults Who Received TAUVID in Clinical Trials (n = 1,921) Adverse Reaction n (%) Headache 26 (1.4%) Injection site pain 23 (1.2%) Increased blood pressure 15 (0.8%) Adverse reactions with a frequency <0.5% in adults who received TAUVID in clinical trials include: Nervous system disorders: dysgeusia
Warnings
Important safety information
Risk of Misdiagnosis in Patients Evaluated for Alzheimer's disease : Consider additional evaluation to confirm the absence of AD pathology in patients with a negative TAUVID scan. ( 2.6 , 5.1 ) Risk of Chronic Traumatic Encephalopathy Misdiagnosis : The safety and effectiveness of TAUVID have not been established for patients being evaluated for CTE. ( 1 , 5.2 ) Radiation Risk : Ensure safe drug handling to protect patients and health care workers from unintentional radiation exposure. ( 2.1 , 5.3 ) 5.1 Risk of Misdiagnosis in Patients Evaluated for Alzheimer's disease 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 NFT pathology. TAUVID performance for detecting tau pathology may be lower in patients in earlier stages of the pathological spectrum [see Clinical Studies ( 14 )] . 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 [see Dosage and Administration ( 2.4 )] . 5.2 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. 5.3 Radiation Risk Diagnostic radiopharmaceuticals, including TAUVID, expose patients to radiation [see Dosage and Administration ( 2.7 )] . 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 [see Dosage and Administration ( 2.1 , 2.2 )] .
Who should not take Tauvid
None. None. ( 4 )
Storing Tauvid, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Diluted product should be used within 4 hours of dilution and prior to product expiry.”
- “Store TAUVID upright in a shielding container [see Dosage and Administration ( 2.”
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- Is there a coupon or discount for Tauvid?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Tauvid. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Tauvid?
- Tauvid is marketed by Avid Radiopharms Inc. You can see Avid Radiopharms Inc's full profile, rating, and other products on pharmaranks.
- Is Tauvid a brand-name or generic drug?
- Tauvid is a brand-name product with the active ingredient Flortaucipir F-18.
- Is Tauvid available over the counter?
- No. Tauvid is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Tauvid come in?
- Tauvid is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Tauvid FDA-registered?
- Tauvid is on record with the U.S. FDA under application number NDA212123. You can verify this on its official FDA label.
- Is Tauvid safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Tauvid. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Tauvid?
- Tauvid's side effects are taken directly from its FDA label. From the label: Most common adverse reactions (frequency ≥ 0.5%) were headache, injection site pain, and increased blood pressure. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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