About NeuraCeq (florbetaben F18 injection)
Indication
NeuraCeq™ is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline.
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A negative NeuraCeq™ scan indicates sparse to no amyloid neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive NeuraCeq™ scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition.
NeuraCeq™ is an adjunct to other diagnostic evaluations.
Limitations of Use
A positive NeuraCeq™ scan does not establish the diagnosis of AD or any other cognitive disorder.
Safety and effectiveness of NeuraCeq™ have not been established for:
Predicting development of dementia or other neurologic conditions;
Monitoring responses to therapies.
Important Safety Information
Risk for Image Interpretation and Other Errors
NeuraCeq™ can be used to estimate the density of beta-amyloid neuritic plaque deposition in the brain. NeuraCeq™ is an adjunct to other diagnostic evaluations. NeuraCeq™ images should be interpreted independent of a patient's clinical information. Physicians should receive training prior to interpretation of NeuraCeq™ images. Following training, image reading errors (especially false positive) may still occur. Additional interpretation errors may occur due to, but not limited to, motion artifacts or extensive brain atrophy.
Radiation Risk
Administration of 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. It is important to ensure safe handling to protect patients and health care workers from unintentional radiation exposure.
Most Common Adverse Reactions
In clinical trials, the most frequently observed adverse drug reactions in 872 subjects with 978 NeuraCeq™ administrations were injection/application site erythema (1.7%), injection site irritation (1.2%), and injection site pain (3.9%).
