18f-fpsma

What it is and how it works

18F-PSMA tracers (e.g. 18F-PSMA-1007 or 18F-DCFPyL) are small-molecule ligands that bind with high affinity to prostate-specific membrane antigen, a transmembrane enzyme strongly over-expressed on most prostate cancer cells. PET imaging localises primary, nodal, bone and soft-tissue disease.

Indications

PET imaging of PSMA-positive lesions in men with prostate cancer: primary staging of high-risk disease, localisation of biochemical recurrence, and selection of patients for PSMA-targeted radioligand therapy.

Dosage and administration (summary)

Dosing is individualised according to the imaging protocol and administered by nuclear medicine specialists as a single intravenous injection.

Contraindications

Hypersensitivity to the active substance or excipients.

Warnings and precautions

PSMA uptake is not specific for prostate cancer and also occurs in salivary and lacrimal glands, ganglia, some benign bone lesions and other tumours, so images must be interpreted with clinical and other imaging data. Patients should hydrate and void frequently to reduce radiation exposure.

Pregnancy

Not applicable to its indication.

Storage and supply

Store at room temperature in appropriate radiation shielding and 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.