Difference between revisions of "Sipuleucel-T (Provenge)"

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m (Text replacement - "[http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or" to "or")
 
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==General information==
 
==General information==
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Class/mechanism: Autologous cellular immunotherapy, with each dose containing a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF.  Autologous peripheral blood mononuclear cells, which include antigen presenting cells (APCs), are obtained via leukapheresis. They are then activated in vitro with prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, linked to [[Sargramostim (Leukine)|granulocyte-macrophage colony-stimulating factor (GM-CSF)]], and reinfused into the patient. The reinfused cells are then hypothesized to mediate immune reactions against prostate cancer cells.<ref name="insert">[http://www.dendreon.com/prescribing-information.pdf Sipuleucel-T (Provenge) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/sipuleucelt.pdf Sipuleucel-T (Provenge) package insert (locally hosted backup)]</ref><ref>[http://www.provenge.com/ Provenge manufacturer's website]</ref>
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Class/mechanism: Autologous cellular immunotherapy, with each dose containing a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF.  Autologous peripheral blood mononuclear cells, which include antigen presenting cells (APCs), are obtained via leukapheresis. They are then activated in vitro with prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, linked to [[Sargramostim (Leukine)|granulocyte-macrophage colony-stimulating factor (GM-CSF)]], and reinfused into the patient. The reinfused cells are then hypothesized to mediate immune reactions against prostate cancer cells.<ref name="insert">[https://www.provenge.com/resources/files/Provenge_Prescribing_Information.pdf Sipuleucel-T (Provenge) package insert]</ref><ref>[[File:SipuleucelT.pdf | Sipuleucel-T (Provenge) package insert (locally hosted backup)]]</ref><ref>[http://www.provenge.com/ Provenge manufacturer's website]</ref>
 
<br>Route: IV
 
<br>Route: IV
 
<br>Extravasation: no information
 
<br>Extravasation: no information
  
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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>  
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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 Micromedex, Lexicomp, or the prescribing information.<ref name="insert"></ref>  
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
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==Patient drug information==
 
==Patient drug information==
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*[http://www.dendreon.com/prescribing-information.pdf#page=16 Sipuleucel-T (Provenge) package insert PDF pages 16-17]<ref name="insert"></ref>
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*[http://www.provenge.com/Portals/_default/Skins/ProvengeDTC/downloads/PRV.0039.USA.18-%20Provenge%20Prescribing%20Information.pdf Sipuleucel-T (Provenge) package insert]<ref name="insert"></ref>
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*[https://chemocare.com/druginfo/provenge Sipuleucel-T (Provenge) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/provenge Sipuleucel-T (Provenge) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/sipuleucel-t-patient-drug-information Sipuleucel-T (Provenge) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/sipuleucel-t-patient-drug-information Sipuleucel-T (Provenge) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/sipuleucel-t-patient-drug-information Sipuleucel-T (Provenge) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/sipuleucel-t-patient-drug-information Sipuleucel-T (Provenge) patient drug information (UpToDate)]</ref>
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==History of changes in FDA indication==
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*2010-04-29: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm210174.htm Initial FDA approval] for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) [[prostate cancer]]. ''(Based on D9901 and IMPACT<sub>prostate</sub>)''
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==History of changes in EMA indication==
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*2013-09-06: Initial authorization for treating men with asymptomatic or minimally symptomatic metastatic (non-visceral) castrate-resistant [[prostate cancer]] in whom chemotherapy is not yet clinically indicated.
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*2015-05-06: Authorization withdrawn at the request of the manufacturer, for commercial reasons
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==Also known as==
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*'''Code name:''' APC-8015
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*'''Brand name:''' Provenge
  
 
==References==
 
==References==
 
<references/>
 
<references/>
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[[Category:Dendritic cell vaccines]]
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[[Category:Intravenous medications]]
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[[Category:Prostate cancer medications]]
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[[Category:FDA approved in 2010]]
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[[Category:EMA approved in 2013]]
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[[Category:EMA withdrawn in 2015]]

Latest revision as of 00:06, 6 July 2024

General information

Class/mechanism: Autologous cellular immunotherapy, with each dose containing a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. Autologous peripheral blood mononuclear cells, which include antigen presenting cells (APCs), are obtained via leukapheresis. They are then activated in vitro with prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, linked to granulocyte-macrophage colony-stimulating factor (GM-CSF), and reinfused into the patient. The reinfused cells are then hypothesized to mediate immune reactions against prostate cancer cells.[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

History of changes in FDA indication

  • 2010-04-29: Initial FDA approval for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. (Based on D9901 and IMPACTprostate)

History of changes in EMA indication

  • 2013-09-06: Initial authorization for treating men with asymptomatic or minimally symptomatic metastatic (non-visceral) castrate-resistant prostate cancer in whom chemotherapy is not yet clinically indicated.
  • 2015-05-06: Authorization withdrawn at the request of the manufacturer, for commercial reasons

Also known as

  • Code name: APC-8015
  • Brand name: Provenge

References

  1. ↑ 1.0 1.1 1.2 Sipuleucel-T (Provenge) package insert
  2. ↑ File:SipuleucelT.pdf
  3. ↑ Provenge manufacturer's website
  4. ↑ Sipuleucel-T (Provenge) patient drug information (Chemocare)
  5. ↑ Sipuleucel-T (Provenge) patient drug information (UpToDate)
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