Safety Information

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Important Safety Information(US)

For safety information outside of the US, visit: Healthcare Professionals Non-US – Neuraceq® Florbetaben F-18 Injection | Life Molecular Imaging

Neuraceq® is 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 and other causes of cognitive decline
  • Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products

Risk for 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 (Section 14 of full US prescribing information)]. 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 (Section 2.4 of full US prescribing information)].

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 (Sections 2.1, 2.2 of full US prescribing information)].

For reporting of adverse events, please send us an email by clicking here, or use the FDA Medwatch reporting form (for adverse event reporting)

To report SUSPECTED ADVERSE REACTIONS, contact Life Molecular Imaging at 1-833-491-2524 or FDA at 1-800-FDA-1088

VIEW FULL PRESCRIBING INFORMATION

This site is intended for US residents. This information is provided for educational purposes only.

Neuraceq® - Product Indications And Use

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

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