Finished product reference
Ac-225-psma
Injection, Solution · Parenteral · 0.2 mCi
- List code
- 53554
- Pharmacologic class
- Radiopharmaceutical; alpha-emitting PSMA-targeted radioligand therapy (investigational / compassionate use)
What it is and how it works
Actinium-225 coupled to a small-molecule ligand of prostate-specific membrane antigen (PSMA, e.g. PSMA-617). After binding PSMA on prostate cancer cells it is internalised and delivers short-range alpha radiation causing lethal DNA double-strand breaks.
Indications
Metastatic castration-resistant prostate cancer with PSMA-positive disease, generally after standard therapies including lutetium-177 PSMA; not an EMA-approved medicine and used under specialist or clinical-trial protocols.
Dosage and administration (summary)
Activity and cycle interval are individualised by the nuclear medicine specialist according to protocol, given by intravenous injection.
Contraindications
Severe bone marrow suppression or severe renal impairment; hypersensitivity to the ligand.
Warnings and precautions
Xerostomia (salivary gland toxicity) is common and may be severe; myelosuppression and nephrotoxicity may occur, requiring monitoring of blood counts and renal function. Radiation protection precautions apply.
Storage and supply
Stored and handled according to national radiation protection regulations, in appropriate lead shielding; short shelf life determined by radioactive decay.
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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