22/20. Flortacipir- (TAUVID) @ (May 2020)- Alzheimers Disease
Drug Name:22/20. Flortacipir- (TAUVID) @ (May 2020)- Alzheimers Disease
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
PATIENT COUNSELING INFORMATION-
Radiation Risk Advise patients of the radiation risk of TAUVID [see Warnings and Precautions (5.3)].
Pregnancy- Advise a pregnant woman of the potential risks of fetal exposure to radiation doses with TAUVID [see Use in Specific Populations (8.1)].
Lactation- Advise a lactating woman to avoid breastfeeding for 4 hours after TAUVID administration in order to minimize radiation exposure to a breastfed infant.
Manufactured for Avid Radiopharmaceuticals, a wholly-owned subsidiary of Eli Lilly and Company, Philadelphia, PA 19104 Copyright © 2020, Eli Lilly and Company. All rights reserved. 7.0-TAU-0000-USPI-202005DD
Indication:
U.S. FDA APPROVED DRUGS DURING 2020
Sr.No- 22
Adverse Reaction:
ADVERSE REACTIONS
The most common reported adverse reactions were headache, injection site pain, and increased blood pressure.
Contra-Indications:
CONTRAINDICATIONS None.
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.
• Risk of Chronic Traumatic Encephalopathy Misdiagnosis: The safety and effectiveness of TAUVID have not been established for patients being evaluated for CTE.
• Radiation Risk: Ensure safe drug handling to protect patients and health care workers from unintentional radiation exposure.
Dosages/ Overdosage Etc:
Patient Information:
No.22 Flortaucipir F 18- (TAUVID)- (May 2020)
PATIENT COUNSELING INFORMATION
Radiation Risk Advise patients of the radiation risk of TAUVID [see Warnings and Precautions (5.3)].
Pregnancy Advise a pregnant woman of the potential risks of fetal exposure to radiation doses with TAUVID
Lactation Advise a lactating woman to avoid breastfeeding for 4 hours after TAUVID administration in order to minimize radiation exposure to a breastfed infant
Manufactured for
Avid Radiopharmaceuticals, a wholly-owned subsidiary of Eli Lilly and Company, Philadelphia, PA 19104 Copyright © 2020, Eli Lilly and Company. All rights reserved. 7.0-TAU-0000-USPI-202005DD
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action- 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.
2. Pharmacodynamics - The relationship between flortaucipir F 18 plasma concentrations and image interpretation was not explored in clinical trials.
Effect of MAO Inhibitors on Flortaucipir Binding in AD Patients TAUVID PET signal was slightly reduced by rasagiline, a MAO-B inhibitor, in vivo in low tau, high MAO-B areas of the brain such as the nucleus accumbens, putamen, and caudate.
However, there is little potential for MAO binding to affect TAUVID scan interpretation in neocortical areas.
3. Pharmacokinetics- After intravenous administration of TAUVID, flortaucipir F 18 was distributed throughout the body with less than 10% of the injected F 18 radioactivity present in the blood by 5 minutes following administration, and less than 5% present in the blood by 10 minutes after administration.
The residual F 18 in circulation during the 80-minute to 100-minute imaging window was approximately 28% to 34% parent, with the remainder being metabolites. Clearance occurs primarily by hepatobiliary and renal excretion.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
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.
2. Lactation Risk Summary- There are no data on the presence of flortaucipir F 18 in human milk, or its effects on the breastfed infant or milk production. Lactation studies have not been conducted in animals.
Advise a lactating woman to avoid breastfeeding for 4 hours after TAUVID administration in order to minimize radiation exposure to a breastfed infant.
3.Pediatric Use- The safety and effectiveness of TAUVID in pediatric patients have not been established.
4.Geriatric Use- Of 1921 study participants in completed clinical studies of TAUVID, 1544 (80%) TAUVID-treated subjects were = 65 years old, while 839 (44%) were = 75 years old.
No overall differences in safety or effectiveness of TAUVID were observed between subjects = 65 years old and younger adult subjects.