Generic Name: radium-233 dichloride
Dosage Form: injection

Indications and Usage for Xofigo
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

Xofigo Dosage and Administration
Recommended Dosage
The dose regimen of Xofigo is 50 kBq (1.35 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 50 kBq/kg body weight or 1.35 microcurie/kg body weight
•
Radioactivity concentration of the product (1,000 kBq/mL; 27 microcurie/mL) at the reference date
•
Decay correction factor to correct for physical decay of radium-223.
The total volume to be administered to a patient is calculated as follows:

Volume to be administered (mL)
 =
 Body weight in kg × 50 kBq/kg body weight
 
Decay factor × 1,000 kBq/mL
    

or

Volume to be administered (mL)
 =
 Body weight in kg × 1.35 microcurie/kg body weight
 
Decay factor × 27 microcurie/mL
    
Table 1: Decay Correction Factor Table Days from Reference Date
 Decay Factor
 Days from Reference Date
 Decay Factor
 
-14
 2.296
 0
 0.982
 
-13
 2.161
 1
 0.925
 
-12
 2.034
 2
 0.870
 
-11
 1.914
 3
 0.819
 
-10
 1.802
 4
 0.771
 
-9
 1.696
 5
 0.725
 
-8
 1.596
 6
 0.683
 
-7
 1.502
 7
 0.643
 
-6
 1.414
 8
 0.605
 
-4
 1.252
 10
 0.536
 
-3
 1.178
 11
 0.504
 
-2
 1.109
 12
 0.475
 
-1
 1.044
 13
 0.447
 
  14
 0.420
 
The Decay Correction Factor Table is corrected to 12 noon Central Standard Time (CST). To determine the decay correction factor, count the number of days before or after the reference date. The Decay Correction Factor Table includes a correction to account for the 7 hour time difference between 12 noon Central European Time (CET) at the site of manufacture and 12 noon US CST, which is 7 hours earlier than CET.
 

Immediately before and after administration, the net patient dose of administered Xofigo should be determined by measurement in an appropriate radioisotope dose calibrator that has been calibrated with a National Institute of Standards and Technology (NIST) traceable radium-223 standard (available upon request from Bayer) and corrected for decay using the date and time of calibration. The dose calibrator must be calibrated with nationally recognized standards, carried out at the time of commissioning, after any maintenance procedure that could affect the dosimetry and at intervals not to exceed one year.

Administration
Administer Xofigo by slow intravenous in