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warnings and cautions
5 WARNINGS AND PRECAUTIONS Risk of Image Misinterpretation and Other Errors: Image interpretation errors have been observed. ( 5.1 ) Radiation Risk: AMYVID contributes to a patient's long-term cumulative radiation exposure. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration. ( 2.1 , 2.2 , 5.2 ) 5.1 Risk of Image Misinterpretation and Other Errors Errors may occur in the estimation of brain amyloid beta neuritic plaque density during AMYVID image interpretation [see Clinical Studies ( 14 )]. The use of clinical information in the interpretation of AMYVID images has not been evaluated and may lead to an inaccurate assessment. Extensive brain atrophy as well as motion artifacts that distort the image may limit the ability to distinguish gray and white matter on an AMYVID scan. Perform image interpretation independently of the patient's clinical information. For cases where there is uncertainty as to the location of cortical signal, use co-registered anatomical imaging to improve localization of signal [see Dosage and Administration ( 2.4 )]. 5.2 Radiation Risk AMYVID contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration ( 2.1 , 2.2 )] .
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 0.4%) were headache, musculoskeletal pain, increased blood pressure, nausea, fatigue, injection site reaction, anxiety, back pain, claustrophobia, dizziness, feeling cold, insomnia, and neck pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 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 clinical practice. The safety of AMYVID was evaluated in 555 adult subjects who received AMYVID by intravenous injection in clinical trials. Table 2 shows adverse reactions reported in ≥ 0.4% of subjects from the clinical trials. Table 2: Adverse Reactions Reported in ≥ 0.4% of Adult Subjects Who Received AMYVID in Clinical Trials a Includes the terms blood pressure increased and hypertension. b Includes the terms injection site hemorrhage, injection site irritation, and injection site pain. c Includes the terms feeling cold and chills. Adverse Reaction AMYVID N=555 % Headache 1.8 Musculoskeletal pain 0.7 Blood pressure increased a 0.7 Nausea 0.7 Fatigue 0.5 Injection site reaction b 0.5 Anxiety 0.4 Back pain 0.4 Claustrophobia 0.4 Dizziness 0.4 Feeling cold c 0.4 Insomnia 0.4 Neck pain 0.4 Adverse reactions that occurred in <0.4% of subjects included infusion site rash, dysgeusia, pruritus, urticaria, and flushing.