Difference between revisions of "Radium-223 (Xofigo)"
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==General information== | ==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 ( | + | 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 <sup>223</sup>RaCl<sub>2</sub>: 293.9 g/mol.<ref name="insert">[http://labeling.bayerhealthcare.com/html/products/pi/Xofigo_PI.pdf Radium Ra 223 (Xofigo) package insert]</ref><ref>[[:File:Radium223.pdf | Radium Ra 223 (Xofigo) package insert (locally hosted backup)]]</ref><ref>[http://xofigo-us.com/index.php Xofigo manufacturer's website]</ref> |
Route: IV | Route: IV | ||
<br>Extravasation: no information | <br>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 | + | 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, or the prescribing information.<ref name="insert"></ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| Line 11: | Line 11: | ||
==Patient drug information== | ==Patient drug information== | ||
| − | *[ | + | *[https://chemocare.com/druginfo/radium-223-dichloride.aspx Radium-223 (Xofigo) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/radium-223-dichloride.aspx Radium-223 (Xofigo) patient drug information (Chemocare)]</ref> |
*Brief patient counseling information can be found in [http://labeling.bayerhealthcare.com/html/products/pi/Xofigo_PI.pdf the Radium-223 (Xofigo) package insert]<ref name="insert"></ref> | *Brief patient counseling information can be found in [http://labeling.bayerhealthcare.com/html/products/pi/Xofigo_PI.pdf the Radium-223 (Xofigo) package insert]<ref name="insert"></ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *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 | + | *2013-11-13: Initial marketing authorization as Xofigo. Xofigo is indicated for the treatment of adults with castration-resistant [[prostate cancer]], symptomatic bone metastases and no known visceral metastases. ''(Based on ALSYMPCA)'' |
| + | ==History of changes in Health Canada indication== | ||
| + | *2013-12-12: Initial notice of compliance (details unavailable) | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2016-03-28: Initial approval for the treatment of castration-resistant [[prostate cancer]] with bone metastases. | ||
==Also known as== | ==Also known as== | ||
*'''Generic names:''' Ra-223, Radium Ra 223 dichloride, Radium-223 chloride | *'''Generic names:''' Ra-223, Radium Ra 223 dichloride, Radium-223 chloride | ||
| Line 35: | Line 39: | ||
[[Category:EMA approved in 2013]] | [[Category:EMA approved in 2013]] | ||
[[Category:FDA approved in 2013]] | [[Category:FDA approved in 2013]] | ||
| + | [[Category:Health Canada approved in 2013]] | ||
| + | [[Category:PMDA approved in 2016]] | ||
Latest revision as of 00:14, 6 July 2024
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, or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Radium-223 (Xofigo) patient drug information (Chemocare)[4]
- Brief patient counseling information can be found in the Radium-223 (Xofigo) package insert[1]
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. Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. (Based on ALSYMPCA)
History of changes in Health Canada indication
- 2013-12-12: Initial notice of compliance (details unavailable)
History of changes in PMDA indication
- 2016-03-28: Initial approval for the treatment of castration-resistant prostate cancer with bone metastases.
Also known as
- Generic names: Ra-223, Radium Ra 223 dichloride, Radium-223 chloride
- Brand names: Alpharadin, Xofigo