Adult Dosing

Beta-amyloid plaque estimation

• Administer 185 MBq [5 millicuries (mCi)] within 40 seconds as a single intravenous bolus in a total volume of 10 mL or less. Follow injection with an IV flush of 5-15 mL of 0.9% NaCl

Note:

• A 20-minute PET image should be acquired starting 90 minutes after IV injection , using a PET scanner in 3-D mode with appropriate data corrections
• Position the patient supine with the brain (including the cerebellum) within a single field of view

Pediatric Dosing

• Safety and effectiveness in pediatric patients has not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• An adjunctive diagnostic agent 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 including polysorbate 80

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustment not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustment not defined

• Ask patients about prior reactions to flutemetamol F 18 as hypersensitivity reactions (flushing and dyspnea) have been observed within minutes following administration; these reactions may occur in patients with no history of prior exposure
• Image interpretation errors (especially false positives) have been observed in the estimation of brain neuritic plaque density during image interpretation; perform image interpretation independently of the patient’s clinical information
• Flutemetamol F 18 contributes to a patient’s overall long-term cumulative radiation exposure which is associated with an increased risk of cancer; hence ensure safe handling to protect patients and health care workers from unintentional radiation exposure

Pregnancy Category:C

Breastfeeding: Safety unknown. Manufacturer advises avoid use in breastfeeding women or temporarily interrupt breastfeeding for 24 hrs after exposure

• CV: Increased blood pressure
• CNS: Headache, dizziness
• GI: Nausea
• DERM: Flushing

• Radiopharmaceutical agent; binds to beta-amyloid plaques in the brain and the F-18 isotope produces a positron signal that is detected by a PET scanner
• Metabolism: Unknown
• Excreted in renal (37%) and hepatobiliary (52%)
• Half-life (physical): 109.8 minutes

US Trade Name(s)

• Vizamyl

US Availability

Vizamyl

• INJ: 150 MBq/mL (4.05mCi/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]

Ophthalmic

Ophthalmic Mydriatics