Molecule
Radium ra-223 dichloride is a radioactive alpha-particle emitting therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. MedsAcross supplies Radium ra-223 dichloride for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
Source: US FDA prescribing information
The active moiety of Xofigo is the alpha particle-emitting isotope radium-223 (as radium Ra 223 dichloride), which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of alpha particles (80 keV/micrometer) leads to a high frequency of double-strand DNA breaks in adjacent cells including tumor cells, osteoblasts and osteoclasts, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium-223 dichloride is less than 100 micrometers (less than 10 cell diameters) which limits damage to the surrounding normal tissue.
Source: US FDA prescribing information
The dose regimen of Xofigo is 55 kBq (1.49 microcurie) per kg body weight, given at 4 week intervals for 6 injections. Recommended Dosage The dose regimen of Xofigo is 55 kBq (1.49 microcurie) per kg body weight, given at 4 week intervals for 6 injections. Safety and efficacy beyond 6 injections with Xofigo have not been studied. The volume to be administered to a given patient should be calculated using the: • Patient’s body weight (kg) • Dosage level 55 kBq/kg body weight or 1.49 microcurie/kg body weight • Radioactivity concentration of the product (1,100 kBq/mL, 30 microcurie/mL) at the reference date • Decay correction factor to correct for physical decay of radium-223.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
• Bone Marrow Suppression: Measure blood counts prior to treatment initiation and before every dose of Xofigo. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after treatment. Monitor patients with compromised bone marrow reserve closely. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care measures. • Increased Fractures and Mortality in Combination with Abiraterone plus Prednisone/Prednisolone: Xofigo is not recommended in combination with abiraterone acetate plus prednisone/prednisolone. • Embryo-Fetal Toxicity: Xofigo can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception.
Source: US FDA prescribing information
The following serious adverse reactions are discussed in greater detail in another section of the label: • Bone Marrow Suppression The most common adverse drug reactions (≥ 10%) in patients receiving Xofigo were nausea, diarrhea, vomiting, and peripheral edema. The most common hematologic laboratory abnormalities (≥ 10%) were anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.
Source: US FDA prescribing information
No formal clinical drug interaction studies have been performed. Subgroup analyses indicated that the concurrent use of bisphosphonates or calcium channel blockers did not affect the safety and efficacy of Xofigo in the randomized clinical trial.
Source: US FDA prescribing information
Store at room temperature, below 40° C (104° F). Store Xofigo in the original container or equivalent radiation shielding.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Radium ra-223 dichloride, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Xofigo 30 µCi/mL injectionIntravenous | Bayer HealthCare Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 15 May 2013 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Radium ra-223 dichloride in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Radium ra-223 dichloride and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Radium ra-223 dichloride, including Xofigo.
Yes. The US FDA first approved Radium ra-223 dichloride on 15 May 2013, according to Drugs@FDA.
No listed presentation of Radium ra-223 dichloride is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Radium ra-223 dichloride is classified under ATC code V10XX03 (Radium ra223 dichloride).
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