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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: NEURACEQ 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 NEURACEQ image interpretation [ see Clinical Studies ( 14 ) ]. The use of clinical information in the interpretation of NEURACEQ images has not been evaluated and may lead to an inaccurate assessment. Severe brain atrophy as well as motion artifacts that result in image distortion may limit the ability to distinguish gray and white matter on a NEURACEQ 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 NEURACEQ 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 )] .
warnings and cautions
5.1 Risk of Image Misinterpretation and Other Errors Errors may occur in the estimation of brain amyloid beta neuritic plaque density during NEURACEQ image interpretation [ see Clinical Studies ( 14 ) ]. The use of clinical information in the interpretation of NEURACEQ images has not been evaluated and may lead to an inaccurate assessment. Severe brain atrophy as well as motion artifacts that result in image distortion may limit the ability to distinguish gray and white matter on a NEURACEQ 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 )] .
warnings and cautions
5.2 Radiation Risk NEURACEQ 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 ≥ 1%) were injection site pain, injection site erythema, and injection site irritation (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Lantheus Biosciences Ltd., a Lantheus company, at 1‑833-491-2524 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 NEURACEQ was evaluated in 872 adult subjects who received NEURACEQ by intravenous injection in clinical trials. Of these subjects, 724 received a single dose, 78 received two doses, and 70 received three doses at yearly intervals as part of annual repeat scanning. Table 2 shows adverse reactions reported in 1% of these 1,090 administrations from the clinical trials. Table 2: Adverse Reactions Reported in 1% of NEURACEQ Administrations in Adults in Clinical Trials Adverse Reaction NEURACEQ N=1,090 Administrations % Injection site pain 3.4 Injection site erythema 1.7 Injection site irritation 1.1
adverse reactions
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 NEURACEQ was evaluated in 872 adult subjects who received NEURACEQ by intravenous injection in clinical trials. Of these subjects, 724 received a single dose, 78 received two doses, and 70 received three doses at yearly intervals as part of annual repeat scanning. Table 2 shows adverse reactions reported in 1% of these 1,090 administrations from the clinical trials. Table 2: Adverse Reactions Reported in 1% of NEURACEQ Administrations in Adults in Clinical Trials Adverse Reaction NEURACEQ N=1,090 Administrations % Injection site pain 3.4 Injection site erythema 1.7 Injection site irritation 1.1