Florbetaben f-18

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 (AD) 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 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 Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products

Florbetaben F 18 binds to amyloid beta plaques in the brain and the F 18 isotope produces a positron signal that is detected by a PET scanner. 3 H-florbetaben in vitro binding experiments revealed two binding sites (K d of 16 nM and 135 nM) in frontal cortex homogenates from patients with AD. Binding of florbetaben F 18 to amyloid beta plaques in postmortem brain sections from patients with AD using autoradiography correlated with both immunohistochemical and Bielschowsky silver stains. Florbetaben F 18 did not bind to tau or α-synuclein in tissue from patients with AD. Neither florbetaben F 18 nor non-radioactive florbetaben F 19 bound to AT8 positive tau deposited in brain tissue from patients with frontotemporal dementia (FTD), using autoradiography and immunohistochemistry, respectively.

The recommended amount of radioactivity is 300 MBq (8.1 mCi) administered as a slow single intravenous bolus (6 sec/mL) in a total volume of up to 10 mL. Follow the injection with an intravenous flush of approximately 10 mL of 0.9% sodium chloride injection. Obtain 15-minute to 20-minute PET images starting approximately 45 minutes to 130 minutes after drug administration. See full prescribing information for image interpretation and radiation dosimetry.

None None.

Risk of Image Misinterpretation and Other Errors: Image interpretation errors have been observed. 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.

Most common adverse reactions (incidence ≥ 1%) were injection site pain, injection site erythema, and injection site irritation.

Store NEURACEQ in the original container with radiation shielding at room temperature 25°C (77°F), excursions permitted to 2°C to 42°C (36°F to 108°F).