Finished product reference
Ac-225-dotatate
Injection, Solution · Parenteral · 0.2 mCi
- List code
- 53553
- Pharmacologic class
- Radiopharmaceutical; alpha-emitting peptide receptor radionuclide therapy (investigational / compassionate use)
What it is and how it works
Actinium-225 linked via the DOTA chelator to the somatostatin analogue octreotate. It binds somatostatin receptors (mainly SSTR2) on neuroendocrine tumour cells and delivers high-energy, short-range alpha radiation causing double-strand DNA breaks.
Indications
Somatostatin receptor-positive, progressive neuroendocrine tumours, typically after failure of or resistance to lutetium-177 based therapy; not an EMA-approved medicine and used under specialist or clinical-trial protocols.
Dosage and administration (summary)
Activity and number of cycles are individualised by the nuclear medicine specialist according to protocol, given by intravenous infusion with renal protective amino acid infusion.
Contraindications
Pregnancy; breastfeeding; severe renal or bone marrow impairment.
Warnings and precautions
Myelosuppression, nephrotoxicity and xerostomia may occur; renal function and blood counts must be monitored. Radiation protection measures apply to patients, carers and staff.
Pregnancy
Contraindicated in pregnancy.
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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