Difference between revisions of "Radium-223 (Xofigo)"

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==History of changes in FDA indication==
 
==History of changes in FDA indication==
*5/15/2013: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm352393.htm FDA approved] for the treatment of patients with castration-resistant [[Prostate cancer|prostate cancer]], symptomatic bone metastases and no known visceral metastatic disease. ''(Based on ALSYMPCA)''
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*2013-05-15: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm352393.htm FDA approved] for the treatment of patients with castration-resistant [[Prostate cancer|prostate cancer]], symptomatic bone metastases and no known visceral metastatic disease. ''(Based on ALSYMPCA)''
  
 
==History of changes in EMA indication==
 
==History of changes in EMA indication==
*11/13/2013: Initial marketing authorization as Xofigo.
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*2013-11-13: Initial marketing authorization as Xofigo.
  
 
==Also known as==
 
==Also known as==

Revision as of 23:50, 4 May 2023

General information

Class/mechanism: Radioactive pharmaceutical agent (radium-223) that mimics some biologic behaviors of calcium and is incorporated into areas with increased bone turnover, such as bone metastases, by forming complexes with hydroxyapatite. Radium-223 emits alpha radiation at the site of bone metastases, which causes double-strand DNA breaks in nearby cells. The limited penetration of alpha radiation (less than 100 micrometers/uM, less than 10 cell diameters) is believed to limit the risk of adverse side effects. Radium-223's half-life is 11.4 days. Its specific activity is 1.9 MBq (51.4 microcurie)/ng; molecular weight of 223RaCl2: 293.9 g/mol.[1][2][3]

Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

  • 2013-05-15: FDA approved for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. (Based on ALSYMPCA)

History of changes in EMA indication

  • 2013-11-13: Initial marketing authorization as Xofigo.

Also known as

  • Generic names: Ra-223, Radium Ra 223 dichloride, Radium-223 chloride
  • Brand names: Alpharadin, Xofigo

References