Flutemetamol F 18

What is Flutemetamol F 18

Flutemetamol F 18 is an intravenous, radioactive diagnostic agent for use with positron emission tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adults with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or other causes of cognitive decline.

A positive PET scan will show moderate (6 to 19) to frequent (more than 20) beta-amyloid plaques in the grey matter of the brain; a negative scan will show sparse (1 to 5) to no plaques.

Flutemetamol F 18 scan readers that undergo special training (in-person or electronic media) interpret the scans with a median sensitivity of 80% to 90% and median specificity of 80%.

Flutemetamol F 18 is an adjunct to other diagnostic evaluations, and a positive scan does not establish a diagnosis of AD or other cognitive disorders.

Safety and effectiveness of flutemetamol F 18 have not been established for predicting development of dementia or other neurologic conditions or for monitoring response to therapies.

Flutemetamol F 18 was FDA-approved in October 2013

Indications

• positron emission tomography (PET) imaging

For use during positron emission tomography (PET) imaging of the brain to estimate beta-amyloid plaque density in patients with cognitive impairment who are being evaluated for Alzheimer’s Disease and other causes of cognitive decline

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

Hypersensitivity reactions such as flushing (2%) and dyspnea have been observed within minutes of flutemetamol F 18 administration. These reactions may occur in patients with no history of prior exposure to flutemetamol F 18. Emergency resuscitation equipment and personnel should be immediately available during flutemetamol F 18 administration.

During clinical trials, 1 patient (out of 761) given flutemetamol F 18 experienced a severe hypersensitivity reaction with flushing, dyspnea, and chest pain (unspecified) that developed within minutes after flutemetamol F 18 administration; symptoms resolved with treatment.

Most adverse drug reactions observed during clinical trials were mild to moderate in severity and resolved spontaneously. Amongst the most frequently reported adverse reactions were increased blood pressure (2%), headache (1%), nausea (1%), and dizziness (1%).

Monitoring Parameters

• pregnancy testing

Contraindications

• accidental exposure
• breast-feeding
• polysorbate 80 hypersensitivity
• pregnancy
• radiation exposure

Interactions

No information is available regarding drug interactions associated with Flutemetamol F 18