Overview
11 DESCRIPTION 11.1 Drug Characteristics NEURACEQ (florbetaben F 18 injection) is a radioactive diagnostic drug for intravenous use. Chemically, florbetaben F 18 is 4-[(E)-2-(4-{2-[2-(2-[ 18 F] fluoroethoxy)ethoxy]ethoxy}phenyl)vinyl]-N-methylaniline. The molecular weight is 358.45 and the structural formula is: NEURACEQ is a sterile, non-pyrogenic, clear solution.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 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.
Indications
- 1 INDICATIONS AND USAGE 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...
Common Doses
- 10 mL
Dosage
2 DOSAGE AND ADMINISTRATION 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. (2.2) Follow the injection with an intravenous flush of approximately 10 mL of 0.9% sodium chloride injection. (2.2) Obtain 15-minute to 20-minute PET images starting approximately 45 minutes to 130 minutes after drug administration. (2.3) See full prescribing information for image interpretation and radiation dosimetry. (2.4, 2.5) 2.
Contraindications
- 4 CONTRAINDICATIONS None None.
Side Effects
- 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. 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.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.