Difference between revisions of "Sipuleucel-T (Provenge)"
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==General information== | ==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 [[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">[ | + | 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>[[Media: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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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *4/29/2010: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm210174.htm Initial FDA approval] | + | *4/29/2010: [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>)'' |
==Also known as== | ==Also known as== | ||
Revision as of 01:30, 25 May 2021
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, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Sipuleucel-T (Provenge) package insert[1]
- Sipuleucel-T (Provenge) patient drug information (Chemocare)[4]
- Sipuleucel-T (Provenge) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 4/29/2010: Initial FDA approval for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. (Based on D9901 and IMPACTprostate)
Also known as
- Code name: APC8015
- Brand name: Provenge