Difference between revisions of "Denosumab (Xgeva)"
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==General information== | ==General information== | ||
Class/mechanism: Human IgG2 monoclonal antibody that inhibits RANK ligand (RANKL). RANKL promotes the formation, function, and survival of osteoclasts, which are responsible for bone resorption.<ref name="insert">[http://pi.amgen.com/united_states/xgeva/xgeva_pi.pdf Denosumab (Xgeva) package insert]</ref><ref>[[Media:Denosumab.pdf | Denosumab (Xgeva) package insert (locally hosted backup)]]</ref><ref>[http://www.xgeva.com/ Xgeva manufacturer's website]</ref><ref>[http://www.prolia.com/ Prolia manufacturer's website]</ref> | Class/mechanism: Human IgG2 monoclonal antibody that inhibits RANK ligand (RANKL). RANKL promotes the formation, function, and survival of osteoclasts, which are responsible for bone resorption.<ref name="insert">[http://pi.amgen.com/united_states/xgeva/xgeva_pi.pdf Denosumab (Xgeva) package insert]</ref><ref>[[Media:Denosumab.pdf | Denosumab (Xgeva) package insert (locally hosted backup)]]</ref><ref>[http://www.xgeva.com/ Xgeva manufacturer's website]</ref><ref>[http://www.prolia.com/ Prolia manufacturer's website]</ref> | ||
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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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> | 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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> | ||
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| + | ==Diseases for which it is used== | ||
| + | *[[Sarcoma|Giant cell tumor of bone]] | ||
==Patient drug information== | ==Patient drug information== | ||
*[http://chemocare.com/chemotherapy/drug-info/denosumab.aspx Denosumab (Xgeva) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/denosumab.aspx Denosumab (Xgeva) patient drug information (Chemocare)]</ref> | *[http://chemocare.com/chemotherapy/drug-info/denosumab.aspx Denosumab (Xgeva) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/denosumab.aspx Denosumab (Xgeva) patient drug information (Chemocare)]</ref> | ||
| − | *Brief patient counseling information can be found on [http://pi.amgen.com/united_states/xgeva/xgeva_pi.pdf#page= | + | *Brief patient counseling information can be found on [http://pi.amgen.com/united_states/xgeva/xgeva_pi.pdf#page=15 page 15 of the Denosumab (Xgeva) package insert]<ref name="insert"></ref> |
*[http://www.uptodate.com/contents/denosumab-patient-drug-information Denosumab (Xgeva) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/denosumab-patient-drug-information Denosumab (Xgeva) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/denosumab-patient-drug-information Denosumab (Xgeva) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/denosumab-patient-drug-information Denosumab (Xgeva) patient drug information (UpToDate)]</ref> | ||
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| + | ==History of changes in FDA indication== | ||
| + | *6/1/2010: [http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm214150.htm FDA approved] (as Prolia) for "treatment of postmenopausal women with osteoporosis at high risk for fracture."<ref>[http://pi.amgen.com/united_states/prolia/prolia_pi.pdf Denosumab (Prolia) package insert]</ref> | ||
| + | *11/18/2010: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234346.htm FDA approved] for "prevention of skeletal-related events in patients with bone metastases from solid tumors."<ref name="insert"></ref> | ||
| + | *6/13/2013: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm356667.htm FDA approved] for "treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity."<ref name="insert"></ref> | ||
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| + | ==Also known as== | ||
| + | Prolia. | ||
==References== | ==References== | ||
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[[Category:Antibody medications]] | [[Category:Antibody medications]] | ||
[[Category:RANK ligand inhibitors]] | [[Category:RANK ligand inhibitors]] | ||
| + | [[Category:Bone cancer medications]] | ||
Revision as of 01:09, 14 June 2013
General information
Class/mechanism: Human IgG2 monoclonal antibody that inhibits RANK ligand (RANKL). RANKL promotes the formation, function, and survival of osteoclasts, which are responsible for bone resorption.[1][2][3][4]
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
- Denosumab (Xgeva) patient drug information (Chemocare)[5]
- Brief patient counseling information can be found on page 15 of the Denosumab (Xgeva) package insert[1]
- Denosumab (Xgeva) patient drug information (UpToDate)[6]
History of changes in FDA indication
- 6/1/2010: FDA approved (as Prolia) for "treatment of postmenopausal women with osteoporosis at high risk for fracture."[7]
- 11/18/2010: FDA approved for "prevention of skeletal-related events in patients with bone metastases from solid tumors."[1]
- 6/13/2013: FDA approved for "treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity."[1]
Also known as
Prolia.
References
- ↑ 1.0 1.1 1.2 1.3 1.4 Denosumab (Xgeva) package insert
- ↑ Denosumab (Xgeva) package insert (locally hosted backup)
- ↑ Xgeva manufacturer's website
- ↑ Prolia manufacturer's website
- ↑ Denosumab (Xgeva) patient drug information (Chemocare)
- ↑ Denosumab (Xgeva) patient drug information (UpToDate)
- ↑ Denosumab (Prolia) package insert