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PRODUCT INDICATIONS AND USE: NEURACEQ is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for:  Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline, and selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products.

NEURACEQ IMPORTANT SAFETY INFORMATION:

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

• Risk for Image Misinterpretation and other Errors
  NEURACEQ Risk of Image Misinterpretation and Other Errors: Image interpretation errors have been observed. [see Section 5.1 of the full prescribing information]
• Radiation Risk
  NEURACEQ, similar to other radiopharmaceuticals, 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 handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration in the full prescribing information].

ADVERSE REACTIONS:

• The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/application site erythema (1.7%), and injection site irritation (1.1%).

USE IN SPECIFIC POPULATIONS:

• Pregnancy : All radiopharmaceuticals, including NEURACEQ, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering NEURACEQ administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
• Lactation : Temporarily discontinue breastfeeding. A lactating woman should pump and discard breast milk for 24 hours after NEURACEQ administration.
• Pediatric Use:  The safety and effectiveness of NEURACEQ have not been established in pediatric patients.
• Geriatric Use: No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger adult subjects.

OVERDOSAGE:
 In the event of administration of a radiation overdose with NEURACEQ, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to NEURACEQ administration, please read the full Prescribing Information for additional Important Safety Information.

SUSPECTED ADVERSE REACTIONS: please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program