Difference between revisions of "Thiotepa (Thioplex)"
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*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 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 [[Bladder cancer|papillary carcinoma of the urinary bladder]]. ''(No supporting studies are cited)'' | *Uncertain date: Approved for treatment of superficial [[Bladder cancer|papillary carcinoma of the urinary bladder]]. ''(No supporting studies are cited)'' | ||
| − | + | ==History of changes in EMA indication== | |
| + | *3/15/2010: Initial authorization as Tepadina | ||
==Also known as== | ==Also known as== | ||
*'''Generic names:''' TESPA, Thiophosphoamide, TSPA | *'''Generic names:''' TESPA, Thiophosphoamide, TSPA | ||
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[[Category:FDA approved in 1959]] | [[Category:FDA approved in 1959]] | ||
| + | [[Category:EMA approved in 2010]] | ||
Revision as of 00:24, 1 January 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
- Bladder cancer
- CNS lymphoma
- Medulloblastoma
- Peripheral T-cell lymphoma
- Transplant conditioning regimens
Diseases for which it was used
Patient drug information
- Patient counseling information can be found in the Thiotepa (Thioplex/Tepadina) package insert[1]
- Thiotepa (Thioplex) patient drug information (Chemocare)[3]
- Thiotepa (Thioplex) patient drug information (UpToDate)[4]
History of changes in FDA indication
- 3/9/1959: 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
- 3/15/2010: Initial authorization as Tepadina
Also known as
- Generic names: TESPA, Thiophosphoamide, TSPA
- Brand names: Tepadina, Thioplex
References
- Drugs
- Intracavitary medications
- Intrathecal medications
- Intravenous medications
- Intravesical medications
- Irritant
- Neutral
- Alkylating agents
- Bladder cancer medications
- CNS lymphoma medications
- Medulloblastoma medications
- Peripheral T-cell lymphoma medications
- Breast cancer medications (historic)
- FDA approved in 1959
- EMA approved in 2010