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Neuraceq Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Multi-dose vial—50mL
Manufacturer
Generic Availability
NO
Mechanism of Action
Florbetaben F 18 is a F18-labeled stilbene derivative, which binds to ß-amyloid plaques in the brain.
Neuraceq Indications
Indications
For positron emission tomography (PET) imaging of the brain to estimate ß-amyloid neuritic plaque density in adults with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline.
Limitations of Use
A positive scan does not establish AD diagnosis or any other cognitive disorder. Safety and efficacy not established for predicting development of dementia or other neurologic conditions; or monitoring response to therapies.
Neuraceq Dosage and Administration
Adult
Give as slow IV bolus at a rate of 6secs/mL into large vein in the arm. 300 MBq (8.1mCi), max 30mcg mass dose, in a total volume of up to 10mL. Follow with saline flush of ~10mL. Acquire PET images over 15–20mins starting 45–130mins after inj.
Children
Not indicated.
Neuraceq Contraindications
Not Applicable
Neuraceq Boxed Warnings
Not Applicable
Neuraceq Warnings/Precautions
Warnings/Precautions
Risk for radiation exposure. Should only be used by trained and experienced physicians in the safe use and handling of radioactive materials to minimize radiation exposure. Risk for image misinterpretation and other errors. Pregnancy. Nursing mothers: pump and discard breast milk for 24hrs post-inj.
Neuraceq Pharmacokinetics
Distribution
Plasma protein bound: 98.5%.
Elimination
Renal. Half-life: ~1hr.
Neuraceq Interactions
Not Applicable
Neuraceq Adverse Reactions
Adverse Reactions
Inj site reactions (erythema, irritation, pain).
Neuraceq Clinical Trials
See Literature
Neuraceq Note
Not Applicable
Neuraceq Patient Counseling
See Literature
