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1 INDICATIONS AND USAGE - Food and Drug Administration

HIGHLIGHTS OF PRESCRIBING INFORMATION -----------------------WARNINGS AND PRECAUTIONS --------------------- These highlights do not include all the information needed to use XOFIGO safely and effectively. See full prescribing information for XOFIGO. Xofigo (radium Ra 223 dichloride) Injection, for intravenous use Initial Approval: 2013 --------------------------- INDICATIONS AND USAGE --------------------------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.

The calculated absorbed radiation doses to different organs are listed in Table 2. The organs with highest absorbed radiation doses were bone (osteogenic cells), red marrow, upper large intestine wall, and lower large intestine wall. The calculated absorbed doses to other organs are lower. Reference ID: 3308326

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