Difference between revisions of "Temozolomide (Temodar)"

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Also known as Temcad and Temodal.
 
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==General information==
 
==General information==
 
Class/mechanism: Alkylator.  Temozolomide is converted in vivo to the reactive compound 5-(3-methyltriazen-
 
Class/mechanism: Alkylator.  Temozolomide is converted in vivo to the reactive compound 5-(3-methyltriazen-
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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.<ref name="insert">[http://www.spfiles.com/pitemodar.pdf Temozolomide (Temodar) package insert]</ref><ref>[[Media:Temozolomide.pdf | Temozolomide (Temodar) package insert (locally hosted backup)]]</ref><ref>[http://temodar.com Temodar manufacturer's website]</ref>
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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.<ref name="insert">[https://www.merck.com/product/usa/pi_circulars/t/temodar_capsules/temodar_pi.pdf Temozolomide (Temodar) package insert]</ref><ref>[[:File:Temozolomide.pdf | Temozolomide (Temodar) package insert (locally hosted backup)]]</ref>
 
<br>Route: PO, IV
 
<br>Route: PO, 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>  
+
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]]
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*[[Bone cancer]]
 
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*[[Central nervous system (CNS) cancer]]
 
 
*[[CNS lymphoma]]
 
*[[CNS lymphoma]]
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*[[Ewing sarcoma]]
 +
*[[Low-grade glioma]]
 +
**[[Low-grade glioma]]
 +
*[[Medulloblastoma]]
 
*[[Melanoma]]
 
*[[Melanoma]]
 
*[[Myelodysplastic syndrome]]
 
*[[Myelodysplastic syndrome]]
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*[[Neuroendocrine tumors]]
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*[[Neuroblastoma]]
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*[[Sarcoma]]
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*[[Neuroendocrine tumor]]
 +
*[[Pancreatic NET]]
 +
*[[Soft tissue sarcoma]]
 
*[[Small cell lung cancer]]
 
*[[Small cell lung cancer]]
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*[[Uveal melanoma]]
 
==Patient drug information==
 
==Patient drug information==
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*[http://www.spfiles.com/ppitemodar.pdf Temozolomide (Temodar) patient drug information from manufacturer]<ref>[http://www.spfiles.com/ppitemodar.pdf Temozolomide (Temodar) patient drug information from manufacturer]</ref>
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*[https://www.merck.com/product/usa/pi_circulars/t/temodar_capsules/temodar_pi.pdf Temozolomide (Temodar) package insert]<ref name="insert"></ref>
 
*[http://chemocare.com/bio/temozolomide.asp Temozolomide (Temodar) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/temozolomide.asp Temozolomide (Temodar) patient drug information (Chemocare)]</ref>
 
*[http://chemocare.com/bio/temozolomide.asp Temozolomide (Temodar) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/temozolomide.asp Temozolomide (Temodar) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/temozolomide-patient-drug-information Temozolomide (Temodar) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/temozolomide-patient-drug-information Temozolomide (Temodar) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/temozolomide-patient-drug-information Temozolomide (Temodar) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/temozolomide-patient-drug-information Temozolomide (Temodar) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
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* 8/11/1999: Initial FDA approval
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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)''
 +
*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)''
 +
*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==
 +
*1999-01-26: Initial marketing authorization as Temodal.
 +
==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==
 +
*'''Generic name:''' TMZ
 +
*'''Brand names:''' Gliotem, Temcad, Temizole, Temodal, Temodar, Temomedac, Temonat, Temoside, Temoz, Temzol
  
 
==References==
 
==References==
 
<references/>
 
<references/>
  
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[[Category:Drug index]]
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[[Category:Drugs]]
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[[Category:Chemotherapy]]
 
 
[[Category:Intravenous medications]]
 
[[Category:Intravenous medications]]
 
[[Category:Oral medications]]
 
[[Category:Oral medications]]
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 +
[[Category:Triazenes]]
 
[[Category:Alkylating agents]]
 
[[Category:Alkylating agents]]
  
 
[[Category:Acute myeloid leukemia medications]]
 
[[Category:Acute myeloid leukemia medications]]
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[[Category:Bone cancer medications]]  
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[[Category:Anaplastic glioma medications]]
−
[[Category:Central nervous system (CNS) cancer medications]]
+
[[Category:CNS lymphoma medications]]
−
[[Category:Central nervous system (CNS) lymphoma medications]]
+
[[Category:Ewing sarcoma medications]]  
 +
[[Category:Glioblastoma 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]]
 +
[[Category:Neuroblastoma medications]]
 
[[Category:Neuroendocrine tumor medications]]
 
[[Category:Neuroendocrine tumor medications]]
 +
[[Category:Pancreatic NET medications]]
 
[[Category:Soft tissue sarcoma medications]]  
 
[[Category:Soft tissue sarcoma medications]]  
 
[[Category:Small cell lung cancer medications]]
 
[[Category:Small cell lung cancer medications]]
 +
[[Category:Uveal melanoma medications]]
  
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[[Category:Drugs FDA approved in 1999]]
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[[Category:EMA approved in 1999]]
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[[Category:FDA approved in 1999]]
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[[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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