Difference between revisions of "Temsirolimus (Torisel)"

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==General information==
 
==General information==
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Class/mechanism: mTOR (mammalian target of rapamycin) inhibitor.  mTOR inhibition by temsirolimus interferes with the ability of mTOR to phosphorylate downstream targets in the PI3 kinase/AKT pathway, such as p70S6k and the S6 ribosomal protein.  Temsirolimus has also been observed to reduce levels of VEGF (vascular endothelial growth factor) and hypoxia-inducible factors HIF-1 and HIF-2 alpha.<ref name="insert">[http://labeling.pfizer.com/showlabeling.aspx?ID=490 Temsirolimus (Torisel) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/temsirolimus.pdf Temsirolimus (Torisel) package insert (locally hosted backup)]</ref><ref>[http://torisel.com/ Torisel manufacturer's website]</ref>
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Class/mechanism: mTOR (mammalian target of rapamycin) inhibitor.  mTOR inhibition by temsirolimus interferes with the ability of mTOR to phosphorylate downstream targets in the PI3 kinase/AKT pathway, such as p70S6k and the S6 ribosomal protein.  Temsirolimus has also been observed to reduce levels of VEGF (vascular endothelial growth factor) and hypoxia-inducible factors HIF-1 and HIF-2 alpha.<ref name="insert">[http://labeling.pfizer.com/showlabeling.aspx?ID=490 Temsirolimus (Torisel) package insert]</ref><ref>[[:File:Temsirolimus.pdf | Temsirolimus (Torisel) package insert (locally hosted backup)]]</ref><ref>[http://torisel.com/ Torisel manufacturer's website]</ref>
 
<br>Route: IV
 
<br>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 [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>  
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==Diseases for which it is established ''(work in progress)''==
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*[[Mantle cell lymphoma]]
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*[[Renal cell carcinoma]]
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
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*[[Diffuse large B-cell lymphoma]]
 
*[[Diffuse large B-cell lymphoma]]
 
*[[Follicular lymphoma]]
 
*[[Follicular lymphoma]]
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*[[Mantle cell lymphoma]]
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*[[Endometrial cancer]]
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*[[Renal cell carcinoma]]
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*[[Hepatoblastoma]]
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*[[Uterine cancer]]
 
  
 
==Patient drug information==
 
==Patient drug information==
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*[http://labeling.pfizer.com/showlabeling.aspx?ID=490 Temsirolimus (Torisel) package insert]<ref name="insert"></ref>
 
*[http://chemocare.com/bio/temsirolimus.asp Temsirolimus (Torisel) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/temsirolimus.asp Temsirolimus (Torisel) patient drug information (Chemocare)]</ref>
 
*[http://chemocare.com/bio/temsirolimus.asp Temsirolimus (Torisel) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/temsirolimus.asp Temsirolimus (Torisel) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/temsirolimus-patient-drug-information Temsirolimus (Torisel) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/temsirolimus-patient-drug-information Temsirolimus (Torisel) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/temsirolimus-patient-drug-information Temsirolimus (Torisel) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/temsirolimus-patient-drug-information Temsirolimus (Torisel) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
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*5/30/2007: Initial FDA approval for the treatment of advanced [[Renal cell carcinoma | renal cell carcinoma]].
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*2007-05-30: Initial FDA approval for the treatment of advanced [[Renal cell carcinoma | renal cell carcinoma]]. ''(Based on ARCC)''
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==History of changes in EMA indication==
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*2007-11-19: Initial authorization as Torisel. Torisel is indicated for the first-line treatment of patients with advanced [[renal cell carcinoma|renal cell carcinoma (RCC)]] who have at least three of six prognostic risk factors. ''(Based on ARCC)''
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*2009-10-14: Extension of Indication to add treatment of adult patients with relapsed and/or refractory [[Mantle cell lymphoma|mantle cell lymphoma (MCL)]].
  
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==History of changes in Health Canada indication==
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*2007-12-21: Initial notice of compliance
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==History of changes in PMDA indication==
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*2010-07-23: Initial approval for the treatment of unresectable or metastatic [[renal cell carcinoma]].
 
==Also known as==
 
==Also known as==
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Precise Name: temsirolimus (RXCUI 657797)
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*'''Code name:''' CCI-779
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*'''Brand name:''' Torisel
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{| class="wikitable" style="text-align:center;"
 
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!colspan="8" align="center" style="background-color:#0066FF"| '''Synonyms'''
 
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|-
 
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|CCI 779
 
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|Torisel
 
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|cell cycle inhibitor 779
 
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|rapamycin analog CCI-779
 
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|}
 
  
 
==References==
 
==References==
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[[Category:Drugs]]
 
[[Category:Drugs]]
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[[Category:Chemotherapy]]
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[[Category:Intravenous medications]]
 
[[Category:Intravenous medications]]
  
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[[Category:Kinase inhibitors]]
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[[Category:mTOR inhibitors]]
 
[[Category:mTOR inhibitors]]
  
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[[Category:Diffuse large B-cell lymphoma medications]]
 
[[Category:Diffuse large B-cell lymphoma medications]]
 
[[Category:Follicular lymphoma medications]]
 
[[Category:Follicular lymphoma medications]]
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[[Category:Hepatoblastoma medications]]
 
[[Category:Mantle cell lymphoma medications]]
 
[[Category:Mantle cell lymphoma medications]]
 
[[Category:Renal_cell_carcinoma medications]]
 
[[Category:Renal_cell_carcinoma medications]]
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[[Category:Uterine cancer medications]]
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[[Category:Endometrial cancer medications]]
  
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[[Category:EMA approved in 2007]]
 
[[Category:FDA approved in 2007]]
 
[[Category:FDA approved in 2007]]
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[[Category:Health Canada approved in 2007]]
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[[Category:PMDA approved in 2010]]

Latest revision as of 00:14, 6 July 2024

General information

Class/mechanism: mTOR (mammalian target of rapamycin) inhibitor. mTOR inhibition by temsirolimus interferes with the ability of mTOR to phosphorylate downstream targets in the PI3 kinase/AKT pathway, such as p70S6k and the S6 ribosomal protein. Temsirolimus has also been observed to reduce levels of VEGF (vascular endothelial growth factor) and hypoxia-inducible factors HIF-1 and HIF-2 alpha.[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 established (work in progress)

Diseases for which it is used

Patient drug information

History of changes in FDA indication

History of changes in EMA indication

  • 2007-11-19: Initial authorization as Torisel. Torisel is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors. (Based on ARCC)
  • 2009-10-14: Extension of Indication to add treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL).

History of changes in Health Canada indication

  • 2007-12-21: Initial notice of compliance

History of changes in PMDA indication

Also known as

  • Code name: CCI-779
  • Brand name: Torisel

References

  1. ↑ 1.0 1.1 1.2 Temsirolimus (Torisel) package insert
  2. ↑ Temsirolimus (Torisel) package insert (locally hosted backup)
  3. ↑ Torisel manufacturer's website
  4. ↑ Temsirolimus (Torisel) patient drug information (Chemocare)
  5. ↑ Temsirolimus (Torisel) patient drug information (UpToDate)
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