Finished product reference
Ra-223 Dichloride
Injection, Solution · Parenteral · 0.2 mCi
- List code
- 53552
- Pharmacologic class
- Therapeutic radiopharmaceutical (alpha emitter)
What it is and how it works
Radium-223 is a calcium mimetic that forms complexes with hydroxyapatite in areas of increased bone turnover such as bone metastases. Its high-energy, short-range alpha particles cause double-strand DNA breaks in adjacent tumour cells with limited damage to surrounding marrow.
Indications
Metastatic castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastases, under licence-specific conditions (e.g. after prior lines of therapy).
Dosage and administration (summary)
Dosing is individualised according to protocol by nuclear medicine specialists; the licensed regimen is based on body weight (kBq/kg) by slow intravenous injection every 4 weeks for six injections.
Contraindications
Not for use in women; contraindicated in combination with abiraterone and prednisone/prednisolone.
Warnings and precautions
Bone marrow suppression (thrombocytopenia, neutropenia) may occur; check blood counts before each dose. Increased fractures and deaths were reported when combined with abiraterone, so bone health should be assessed; men should use effective contraception, and radiation-protection measures are required.
Pregnancy
Not indicated in women.
Storage and supply
Store according to radiopharmaceutical regulations in the original lead-shielded container; no special temperature requirements stated beyond the manufacturer’s instructions.
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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