Difference between revisions of "Temozolomide (Temodar)"

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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 established==
 +
*[[Anaplastic glioma]]
 +
*[[Glioblastoma]]
 
==Diseases for which it is used==
 
==Diseases for which it is used==
 
*[[Acute myeloid leukemia]]
 
*[[Acute myeloid leukemia]]
−
*[[Anaplastic glioma]]
 
 
*[[CNS lymphoma]]
 
*[[CNS lymphoma]]
 
*[[Ewing sarcoma]]
 
*[[Ewing sarcoma]]
−
*[[Glioblastoma]]
 
 
*[[Low-grade glioma]]
 
*[[Low-grade glioma]]
 +
**[[Low-grade glioma]]
 +
*[[Medulloblastoma]]
 
*[[Melanoma]]
 
*[[Melanoma]]
 
*[[Myelodysplastic syndrome]]
 
*[[Myelodysplastic syndrome]]
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==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
* 8/11/1999: Initial accelerated approval for treatment of adult patients with refractory [[Anaplastic_glioma|anaplastic astrocytoma]], i.e., patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine. ''(Based on Yung et al. 1999)''
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* 1999-08-11: Initial accelerated approval for treatment of adult patients with refractory [[Anaplastic_glioma|anaplastic astrocytoma]], i.e., patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine. ''(Based on MK-7365-006)''
−
*3/15/2005: Approved for newly diagnosed [[Glioblastoma|glioblastoma multiforme (GBM)]] concomitantly with radiotherapy and then as maintenance treatment. ''(Based on EORTC 22981/26981; NCIC-CTG CE.3)''
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*2005-03-15: Regular approval for newly diagnosed [[Glioblastoma|glioblastoma multiforme (GBM)]] concomitantly with radiotherapy and then as maintenance treatment. ''(Based on EORTC 22981/26981; NCIC-CTG CE.3)''
−
*3/15/2005: Approved for refractory [[Anaplastic_glioma|anaplastic astrocytoma]] patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. ''(Based on Yung et al. 1999)''
+
*2005-03-15: Regular approval for refractory [[Anaplastic_glioma|anaplastic astrocytoma]] patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. ''(Based on MK-7365-006)''
 +
*2023-09-14: Project Renewal revised indication for adjuvant treatment of adults with newly diagnosed [[Anaplastic_glioma|anaplastic astrocytoma]]. ''(Based on CATNON)''
 +
*2023-09-14: Project Renewal revised indication for treatment of adults with refractory [[Anaplastic_glioma|anaplastic astrocytoma]]. ''(Based on MK-7365-006)''
  
 
==History of changes in EMA indication==
 
==History of changes in EMA indication==
−
*1/26/1999: Initial marketing authorization as Temodal.
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*1999-01-26: Initial marketing authorization as Temodal.
−
 
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==History of changes in PMDA indication==
 +
*2006-07-26: Initial approval for treatment of [[:Category:Malignant gliomas|malignant glioma]].
 +
*2019-02-21: New additional indication and a new dosage for the treatment of relapsed or refractory [[Ewing sarcoma|Ewing's sarcoma]].
 
==Also known as==
 
==Also known as==
 
*'''Generic name:''' TMZ
 
*'''Generic name:''' TMZ
−
*'''Brand names:''' Gliotem, Temcad, Temizole, Temodal, Temodar, Temonat, Temoside, Temoz, Temzol
+
*'''Brand names:''' Gliotem, Temcad, Temizole, Temodal, Temodar, Temomedac, Temonat, Temoside, Temoz, Temzol
 +
 
 
==References==
 
==References==
 
<references/>
 
<references/>
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[[Category:Glioblastoma medications]]
 
[[Category:Glioblastoma medications]]
 
[[Category:Low-grade glioma medications]]
 
[[Category:Low-grade glioma medications]]
 +
[[Category:Low-grade glioma, pediatric medications]]
 +
[[Category:Medulloblastoma medications]]
 
[[Category:Melanoma medications]]  
 
[[Category:Melanoma medications]]  
 
[[Category:Myelodysplastic syndrome medications]]
 
[[Category:Myelodysplastic syndrome medications]]
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[[Category:EMA approved in 1999]]
 
[[Category:EMA approved in 1999]]
 
[[Category:FDA approved in 1999]]
 
[[Category:FDA approved in 1999]]
 +
[[Category:PMDA approved in 2006]]

Latest revision as of 00:26, 7 November 2023

General information

Class/mechanism: Alkylator. Temozolomide is converted in vivo to the reactive compound 5-(3-methyltriazen- 1-yl)-imidazole-4-carboxamide (MTIC). MTIC causes alkylation of DNA at the O6 and N7 positions of guanine, leading to cell damage and cell death.[1][2]
Route: PO, 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 established

Diseases for which it is used

Patient drug information

History of changes in FDA indication

  • 1999-08-11: Initial accelerated approval for treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine. (Based on MK-7365-006)
  • 2005-03-15: Regular approval for newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and then as maintenance treatment. (Based on EORTC 22981/26981; NCIC-CTG CE.3)
  • 2005-03-15: Regular approval for refractory anaplastic astrocytoma patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. (Based on MK-7365-006)
  • 2023-09-14: Project Renewal revised indication for adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (Based on CATNON)
  • 2023-09-14: Project Renewal revised indication for treatment of adults with refractory anaplastic astrocytoma. (Based on MK-7365-006)

History of changes in EMA indication

  • 1999-01-26: Initial marketing authorization as Temodal.

History of changes in PMDA indication

  • 2006-07-26: Initial approval for treatment of malignant glioma.
  • 2019-02-21: New additional indication and a new dosage for the treatment of relapsed or refractory Ewing's sarcoma.

Also known as

  • Generic name: TMZ
  • Brand names: Gliotem, Temcad, Temizole, Temodal, Temodar, Temomedac, Temonat, Temoside, Temoz, Temzol

References

  1. ↑ 1.0 1.1 1.2 Temozolomide (Temodar) package insert
  2. ↑ Temozolomide (Temodar) package insert (locally hosted backup)
  3. ↑ Temozolomide (Temodar) patient drug information (Chemocare)
  4. ↑ Temozolomide (Temodar) patient drug information (UpToDate)
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