Adult Dosing

Beta-Amyloid Plaque Estimation

• Recommended dose: 300 MBq (8.1 mCi), maximum 30 mcg mass dose, administered as a single slow IV bolus (6 sec/mL) in a total volume of up to 10 mL

Note:

• Inspect the radiopharmaceutical dose solution before administration and do not use it if it contains particulate matter
• Aseptic technique should be used and radiation shielding to withdraw and administer florbetaben F 18 solution
• Measure the activity of florbetaben F 18 with a dose calibrator immediately before injection
• Do not dilute florbetaben F 18
• An injection (6 sec/mL) into a large vein in the arm is recommended, followed by a saline flush of approximately10 mL
• Refer package insert for image acquisition guidelines, image display and interpretation and radiation dosimetry

Pediatric Dosing

• Not indicated for use in pediatric patients

[Outline]

• Adult Dosing
• Pediatric Dosing

• Used for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Errors may occur in the florbetaben F 18 estimation of brain neuritic beta-amyloid plaque density during image interpretation
• A positive Neurace scan does not establish the diagnosis of AD or any other cognitive disorder
• Long-term cumulative radiation exposure may lead to increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure

Pregnancy Category:C

Breastfeeding: Manufacturer advises avoid use of the drug in a breastfeeding mother or have the mother temporarily interrupt breastfeeding for 24 hours after exposure to florbetaben F 18. If breastfeeding is interrupted, instruct patient to pump and discard her breast milk and use alternate nutrition sources for 24 hours after the administration

• LOCAL: Injection/application site erythema, injection site irritation, injection site pain

• Diagnostic agent; binds to beta-amyloid plaques and the F 18 isotope produces a positron signal that is detected by a PET scanner
• 98.5% bound to plasma proteins and is eliminated from plasma primarily via the hepatobiliary route
• Half life: 1 hour

US Trade Name(s)

• Neuraceq

US Availability

Neuraceq

• INJ: 50 to 5000 Mbq/mL (1.4-135 mCi/mL)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Radiologic

Diagnostic Agents