Finished product reference

Ga-68-fap-2286

Injection, Solution · Parenteral · 5 mCi

List code
53556
Pharmacologic class
Diagnostic radiopharmaceutical; gallium-68 labelled fibroblast activation protein (FAP)-targeted peptide PET tracer (investigational)

What it is and how it works

68Ga-FAP-2286 is a cyclic peptide conjugate that binds with high affinity to fibroblast activation protein, a membrane protease strongly expressed on cancer-associated fibroblasts in the stroma of many epithelial tumours and largely absent from normal adult tissues. PET imaging visualises FAP-expressing tumour stroma.

Indications

Investigational PET imaging of FAP-expressing solid tumours and their metastases and selection of patients for FAP-targeted radioligand therapy; it is used under clinical research or national special-access arrangements rather than a standard marketing authorisation.

Dosage and administration (summary)

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

Contraindications

Hypersensitivity to the active substance or excipients.

Warnings and precautions

FAP uptake is not tumour-specific and also occurs in fibrosis, wound healing, arthritis, atherosclerotic plaques and other inflammatory or fibrotic processes, so images must be interpreted alongside clinical and other imaging findings. Radiation exposure should be kept as low as reasonably achievable.

Pregnancy

Generally avoided in pregnancy because of fetal radiation exposure.

Storage and supply

Prepared on site and used within its short shelf-life (gallium-68 half-life about 68 minutes), kept in appropriate radiation shielding.

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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