Flortaucipir F-18
Generic Name: flortaucipir f-18
Brand Names:
Tauvid
11 DESCRIPTION 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.
Overview
11 DESCRIPTION 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.
Uses
1 INDICATIONS AND USAGE TAUVID 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). TAUVID is a radioactive diagnostic agent indicated for 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). ( 1 ) Limitations of Use TAUVID is not indicated for use in the evaluation of patients for chronic traumatic encephalopathy (CTE).
Dosage
2 DOSAGE AND ADMINISTRATION 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.
Side Effects
6 ADVERSE REACTIONS 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 )] .
Warnings
5 WARNINGS AND PRECAUTIONS 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. 4 CONTRAINDICATIONS None. None. ( 4 )
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.
Storage
16.2 Storage and Handling Storage Store TAUVID at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . TAUVID does not contain a preservative. Store TAUVID upright in a shielding container [see Dosage and Administration ( 2.1 )] . The expiration date and time are provided on the container label. Use TAUVID within the labeled expiration.
Frequently Asked Questions
What is Flortaucipir F-18 used for?▼
1 INDICATIONS AND USAGE TAUVID 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). TAUVID is a radioactive diagnostic agent indicated for 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). ( 1 ) Limitations of Use TAUVID is not indicated for use in the evaluation of patients for chronic traumatic encephalopathy (CTE).
What are the side effects of Flortaucipir F-18?▼
6 ADVERSE REACTIONS 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 )] .
Can I take Flortaucipir F-18 during 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.
What are the important warnings for Flortaucipir F-18?▼
5 WARNINGS AND PRECAUTIONS 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. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.