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warnings and cautions
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. 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 )] .
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adverse reactions
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 )] . 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
adverse reactions table
Table 2: Adverse Reactions with a Frequency ≥0.5% in Adults Who Received TAUVID in Clinical Trials (n = 1,921) Adverse Reactionn (%)Headache 26 (1.4%) Injection site pain 23 (1.2%) Increased blood pressure 15 (0.8%)