Finished product reference

18f-fbp

Injection, Solution · Parenteral · 5 mCi

List code
53548
Pharmacologic class
Diagnostic radiopharmaceutical; fluorine-18 labelled amyloid PET tracer (18F-florbetapir)

What it is and how it works

18F-FBP (florbetapir F 18) is a positron-emitting tracer that crosses the blood–brain barrier and binds to fibrillar β-amyloid plaques. PET imaging of its distribution provides an estimate of cerebral β-amyloid neuritic plaque density.

Indications

PET imaging of the brain to estimate β-amyloid plaque density in adults with cognitive impairment being evaluated for Alzheimer’s disease and other causes of cognitive decline, as an adjunct to other diagnostic evaluations.

Dosage and administration (summary)

Dosing is individualised according to the imaging protocol and administered by nuclear medicine specialists as a single intravenous bolus; activity is measured in a dose calibrator before administration.

Contraindications

Hypersensitivity to the active substance or excipients.

Warnings and precautions

A positive scan does not by itself establish a diagnosis of Alzheimer’s disease, and images should be interpreted only by readers trained in the method. Radiation exposure should be kept as low as reasonably achievable, and patients should be well hydrated and void frequently after the scan.

Pregnancy

Generally avoided in pregnancy unless the diagnostic information is essential, because of fetal radiation exposure.

Storage and supply

Store at room temperature in appropriate radiation shielding in accordance with national regulations on radioactive materials; use within the short shelf-life stated on the label.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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