Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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 <0.5% in adults who received TAUVID in clinical trials include: Nervous system disorders: dysgeusia
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.
Like all medications, Tauvid can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: