Thiotepa (Thioplex)

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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, 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