Difference between revisions of "Thiotepa (Thioplex)"

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(Created page with "==General information== Class/mechanism: <ref name="insert">[http://patient.cancerconsultants.com/druginserts/Thiotepa.pdf Thiotepa (Thioplex) package insert]</ref><ref>[http://h...")
 
 
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==General information==
 
==General information==
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Class/mechanism: <ref name="insert">[http://patient.cancerconsultants.com/druginserts/Thiotepa.pdf Thiotepa (Thioplex) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/thiotepa.pdf Thiotepa (Thioplex) package insert (locally hosted backup)]</ref>
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Class/mechanism: Alkylator, ethylenimine-type, similar to nitrogen mustards.  Ethylenimine radicals are released, which alkylates at the N7 position of guanine, resulting in the linkage between the purine and sugar being severed, and subsequent cell damage and death.<ref name="insert">[https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208264s000lbl.pdf Thiotepa (Thioplex/Tepadina) package insert]</ref><ref>[[:File:Thiotepa.pdf | Thiotepa (Thioplex/Tepadina) package insert (locally hosted backup)]]</ref>
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<br>Route: TBD
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<br>Route: IV, intravesicular, intracavitary; (off-label: IT)
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<br>Extravasation: TBD
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<br>Extravasation: [[irritant]] or [[neutral]], depending on reference
  
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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 package insert<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 [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 used==
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*[[Bladder cancer]]
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*[[CNS lymphoma]]
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*[[Medulloblastoma]]
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*[[Peripheral T-cell lymphoma]]
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==Diseases for which it was used==
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*[[Breast cancer - historical|Breast cancer]]
  
 
==Patient drug information==
 
==Patient drug information==
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*[http://chemocare.com/bio/thiotepa.aspThiotepa (Thioplex) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/thiotepa.aspThiotepa (Thioplex) patient drug information (Chemocare)]</ref>
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*Patient counseling information can be found in the [https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208264s000lbl.pdf Thiotepa (Thioplex/Tepadina) package insert]<ref name="insert"></ref>
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*[http://chemocare.com/bio/thiotepa.asp Thiotepa (Thioplex) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/thiotepa.asp Thiotepa (Thioplex) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/thiotepa-patient-drug-information Thiotepa (Thioplex) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/thiotepa-patient-drug-information Thiotepa (Thioplex) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/thiotepa-patient-drug-information Thiotepa (Thioplex) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/thiotepa-patient-drug-information Thiotepa (Thioplex) patient drug information (UpToDate)]</ref>
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==History of changes in FDA indication==
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*1959-03-09: Initial FDA approval
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*Uncertain date: Approved to reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with [[Beta thalassemia|class 3 beta-thalassemia]].
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*Uncertain date: Approved for treatment of adenocarcinoma of the [[Breast cancer|breast]] or [[Ovarian cancer|ovary]]. ''(No supporting studies are cited)''
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*Uncertain date: Approved for controlling intracavitary effusions secondary to diffuse or localized [[:Category:Malignant neoplasm|neoplastic diseases]] of various serosal cavities. ''(No supporting studies are cited)''
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*Uncertain date: Approved for treatment of superficial [[Bladder cancer|papillary carcinoma of the urinary bladder]]. ''(No supporting studies are cited)''
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==History of changes in EMA indication==
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*1959-03-09: EURD
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*2010-03-15: Initial authorization as Tepadina
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==History of changes in Health Canada indication==
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*2017-03-29: Notice of compliance with conditions in combination with other chemotherapeutic products as part of a high-dose chemotherapy (HDCT) consolidation regimen followed by autologous stem cell transplantation (ASCT) for adult patients with [[CNS lymphoma|central nervous system (CNS) lymphoma]].
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==History of changes in PMDA indication==
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*2019-03-26: Newly approved for the conditioning treatment of [[:Category:Malignant solid neoplasm|solid tumors]] in pediatric patients prior to autologous hematopoietic stem-cell transplantation.
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*2020-03-25: New indication and a new dosage for the conditioning treatment of [[:Category:Lymphomas|malignant lymphoma]] in patients prior to autologous hematopoietic stem-cell transplantation.
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==Also known as==
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*'''Generic names:''' TESPA, Thiophosphoamide, TSPA
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*'''Brand names:''' Rethio, Tepadina, Thioplex
  
 
==References==
 
==References==
 
<references/>
 
<references/>
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[[Category:Drugs]]
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[[Category:Intracavitary medications]]
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[[Category:Intrathecal medications]]
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[[Category:Intravenous medications]]
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[[Category:Intravesical medications]]
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[[Category:Irritant]]
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[[Category:Neutral]]
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[[Category:Alkylating agents]]
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[[Category:Bladder cancer medications]]
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[[Category:CNS lymphoma medications]]
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[[Category:Medulloblastoma medications]]
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[[Category:Peripheral T-cell lymphoma medications]]
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[[Category:Breast cancer medications (historic)]]
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[[Category:FDA approved in 1959]]
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[[Category:EMA approved in 1959]]
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[[Category:PMDA approved in 2019]]

Latest revision as of 21:58, 20 December 2023

General information

Class/mechanism: Alkylator, ethylenimine-type, similar to nitrogen mustards. Ethylenimine radicals are released, which alkylates at the N7 position of guanine, resulting in the linkage between the purine and sugar being severed, and subsequent cell damage and death.[1][2]
Route: IV, intravesicular, intracavitary; (off-label: IT)
Extravasation: irritant or neutral, depending on reference

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

Diseases for which it was used

Patient drug information

History of changes in FDA indication

  • 1959-03-09: Initial FDA approval
  • Uncertain date: Approved to reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia.
  • Uncertain date: Approved for treatment of adenocarcinoma of the breast or ovary. (No supporting studies are cited)
  • Uncertain date: Approved for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. (No supporting studies are cited)
  • Uncertain date: Approved for treatment of superficial papillary carcinoma of the urinary bladder. (No supporting studies are cited)

History of changes in EMA indication

  • 1959-03-09: EURD
  • 2010-03-15: Initial authorization as Tepadina

History of changes in Health Canada indication

  • 2017-03-29: Notice of compliance with conditions in combination with other chemotherapeutic products as part of a high-dose chemotherapy (HDCT) consolidation regimen followed by autologous stem cell transplantation (ASCT) for adult patients with central nervous system (CNS) lymphoma.

History of changes in PMDA indication

  • 2019-03-26: Newly approved for the conditioning treatment of solid tumors in pediatric patients prior to autologous hematopoietic stem-cell transplantation.
  • 2020-03-25: New indication and a new dosage for the conditioning treatment of malignant lymphoma in patients prior to autologous hematopoietic stem-cell transplantation.

Also known as

  • Generic names: TESPA, Thiophosphoamide, TSPA
  • Brand names: Rethio, Tepadina, Thioplex

References

  1. ↑ 1.0 1.1 1.2 Thiotepa (Thioplex/Tepadina) package insert
  2. ↑ Thiotepa (Thioplex/Tepadina) package insert (locally hosted backup)
  3. ↑ Thiotepa (Thioplex) patient drug information (Chemocare)
  4. ↑ Thiotepa (Thioplex) patient drug information (UpToDate)
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