Florbetaben F 18 Brand Name– Neuraceq
What is Florbetaben F 18
Florbetaben F 18 is an intravenous, radioactive, diagnostic agent used to estimate beta-amyloid neuritic plaque density.
It is approved for use with Positron Emission Tomography (PET) brain imaging to evaluate adults for Alzheimer’s Disease (AD) or other causes of cognitive decline. A positive PET scan is indicated by the presence of moderate (6?19) to frequent (>= 20) beta-amyloid plaques in the gray matter of the brain; a negative scan indicates sparse (1?5) to no plaques.
Studies have found that readers undergoing special training (in-person and electronic media training) were able to interpret the scans with a median sensitivity of 96—98% and median specificity of 77—80%.
Florbetaben F 18 PET imaging is only intended for use as an adjunct to other diagnostic tests and does not establish a diagnosis of AD or other cognitive disorders.
Additionally, the images cannot be used to predict development of neurologic conditions nor response to therapy.
Florbetaben F 18 was approved by the FDA in March 2014
Indications
- positron emission tomography (PET) imaging
For use during positron emission tomography (PET) imaging of the brain to estimate beta-amyloid plaque density in adults being evaluated for Alzheimer’s disease and other causes of cognitive decline
NOTE: Not indicated to predict the development of a neurologic condition nor for monitoring response to therapy.
NOTE: This drug is a radiopharmaceutical and should be administered by individuals specifically trained in the handling of radioactive material.
NOTE: Dosage measured in megabecquerels (MBq) and millicuries (mCi).
Side Effects
- erythema
- injection site reaction
- skin irritation
No serious adverse reactions were observed following use of florbetaben F 18 during clinical trials. Injection site reaction, defined as erythema (1.7%), skin irritation (1.1%), and pain (3.4%), were the most frequently reported events. All reactions were short in duration and mild to moderate in severity.
Monitoring Parameters
- pregnancy testing
Contraindications
- accidental exposure
- breast-feeding
- pregnancy
Interactions
No information is available regarding drug interactions associated with Florbetaben F 18
