"The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for"...
There have been no reports of inadvertent overdosing of Xofigo during clinical studies.
There is no specific antidote. In the event of an inadvertent overdose of Xofigo, utilize general supportive measures, including monitoring for potential hematological and gastrointestinal toxicity, and consider using medical countermeasures such as aluminum hydroxide, barium sulfate, calcium carbonate, calcium gluconate, calcium phosphate, or sodium alginate.1
Single Xofigo doses up to 250 kBq (6.76 microcurie) per kg body weight were evaluated in a phase 1 clinical trial and no dose-limiting toxicities were observed.
Xofigo is contraindicated in pregnancy.
Xofigo can cause fetal harm when administered to a pregnant woman based on its mechanism of action. Xofigo is not indicated for use in women. Xofigo is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus [see Use In Specific Populations].
1. Radiation Emergency Medical Management. [REMM/National Library of Medicine Website.] http://www.remm.nlm.gov/int_contamination.htm#blockingagentsThis monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/24/2013
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