Radium Ra 223 dichloride

(Xofigo®)

Radium Ra 223 dichloride

Drug updated on 9/4/2024

Dosage FormInjection (intravenous; 1,100 kBq/mL [30 microcurie/mL])
Drug ClassAlpha particle-emitting radioactive therapeutic agents
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

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Summary
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  • Xofigo (radium Ra 223 dichloride) is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease.
  • This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
  • Effectiveness in Survival and Quality of Life: Radium-223 (Ra-223) combined with new-generation hormonal agents (NHAs) like abiraterone acetate plus prednisone (AAP) or enzalutamide may improve survival and quality of life for patients with bone metastatic castration-resistant prostate cancer (mCRPC).
  • Comparative Effectiveness: There is no direct comparative data on effectiveness outcomes (such as survival rates or quality of life) between Ra-223 monotherapy and NHA monotherapy in the study.
  • Higher fracture incidence was observed in both Ra-223 combined with NHAs (OR: 3.22, 95% CI: 2.24-4.63, P < 0.01) and Ra-223 monotherapy (OR: 2.24, 95% CI: 1.23-4.08, P < 0.01) compared to NHA monotherapy, with no significant difference between Ra-223 monotherapy and NHA monotherapy (OR: 1.14, 95% CI: 0.22-5.95, P = 0.88). No significant differences were found in symptomatic skeletal events, SSE-free survival, or common and ≥Grade 3 adverse events among the groups.
  • There is no population type or subgroup information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Xofigo (radium Ra 223 dichloride) Prescribing Information.2019Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ

Systematic Reviews / Meta-Analyses