Xofigo® - radium Ra 223 dichloride injection

Important Safety Information

  • Contraindications: Xofigo is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when
    administered to a pregnant woman
  • Bone Marrow Suppression: In the randomized trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing
    pancytopenia, compared to no patients treated with placebo. Continue reading below

When is it time to start Xofigo®?

XOFIGO IS INDICATED
for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.1

  • Checkbox Bone metastases?1
  • Checkbox First sign of symptoms?1
  • Start Checkbox to extend survival1,2
PATIENTS

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30% reduction in the risk of death vs placebo1

  • In the ALSYMPCA exploratory updated analysis,a median overall survival was 14.9 months for Xofigo (95% confidence interval
    [CI]: 13.9-16.1) vs 11.3 months for placebo (95% CI: 10.4-12.8) [hazard ratio (HR)=0.695; 95% CI: 0.581-0.832]1
  • In the ALSYMPCA prespecified interim analysis, median overall survival was 14.0 months for Xofigo (95% CI: 12.1-15.8)
    vs 11.2 months for placebo (95% CI: 9.0-13.2) [P=0.00185 (HR=0.695; 95% CI: 0.552-0.875)]1

aAn exploratory updated overall survival analysis was performed before patient crossover, incorporating an additional 214 events, resulting in findings consistent with the interim analysis.1

Indication

Xofigo® (radium Ra 223 dichloride) injection is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.

Important Safety Information


You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. For important risk and use information about Xofigo, please see the full Prescribing Information.

References: 1. Xofigo® (radium Ra 223 dichloride) injection [prescribing information]. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc.; May 2013. 2. Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013;369(3):213-223.