(95% CI)
 14.0

(12.1, 15.8)
 11.2

( 9.0, 13.2)
 
p-value†
 0.00185
 
Hazard ratio (95% CI)‡
 0.695 (0.552, 0.875)
 
   
Updated Analysis
  
Subjects randomized
 614
 307
 
Number of deaths
 333 (54.2%)
 195 (63.5%)
 
Censored
 281 (45.8%)
 112 (36.5%)
 
Median survival (months)*

(95% CI)
 14.9

(13.9, 16.1)
 11.3

(10.4, 12.8)
 
Hazard ratio (95% CI)‡
 0.695 (0.581, 0.832)

The Kaplan-Meier curves for overall survival based on the updated survival results are shown in Figure 1.

Figure 1: Kaplan-Meier Overall Survival Curves from the Phase 3 Clinical Trial

The survival results were supported by a delay in the time to first SSE favoring the Xofigo arm. The majority of events consisted of external beam radiotherapy to bone metastases.

15 REFERENCES
1.
Radiation Emergency Medical Management. [REMM/National Library of Medicine Website.] http://www.remm.nlm.gov/int_contamination.htm#blockingagents
 
16 HOW SUPPLIED/STORAGE AND HANDLING
Xofigo (radium Ra 223 dichloride injection) is supplied in single-use vials containing 6 mL of solution at a concentration of 1,000 kBq/mL (27 microcurie/mL) with a total radioactivity of 6,000 kBq/vial (162 microcurie/vial) at the reference date (NDC 50419-208-01).

Store at room temperature, below 40° C (104° F). Store Xofigo in the original container or equivalent radiation shielding.

This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

Follow procedures for proper handling and disposal of radioactive pharmaceuticals [see Dosage and Administration (2.3)].

17 PATIENT COUNSELING INFORMATION
Advise patients:
•
To be compliant with blood cell count monitoring appointments while receiving Xofigo. Explain the importance of routine blood cell counts. Instruct patients to report signs of bleeding or infections.
•
To stay well hydrated and to monitor oral intake, fluid status, and urine output while being treated with Xofigo. Instruct patients to report signs of dehydration, hypovolemia, urinary retention, or renal failure / insufficiency.
•
There are no restrictions regarding contact with other people after receiving Xofigo. Follow good hygiene practices while receiving Xofigo and for at least 1 week after the last injection in order to minimize radiation exposure from bodily fluids to household members and caregivers. Whenever possible, patients should use a toilet and the toilet should be flushed several times after each use. Clothing soiled with patient fecal matter or urine should be washed promptly and separately from other clothing. Caregivers should use universal precautions for patient care such as gloves and barrier gowns when handling bodily fluids to avoid contamination. When handling bodily fluids, wearing gloves and hand washing will protect care