Arsenic trioxide (Trisenox)

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General information

Class/mechanism: Causes damage or degradation of PML-RAR alpha fusion protein, causes apoptosis-type changes in NB4 human promyelocytic leukemia cells in vitro.[1][2][3]
Route: IV
Extravasation: irritant

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, Medscape, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

History of changes in EMA indication

  • 2002-03-05: Initial authorization (Based on PLRXAS01 & 97-66)
  • 2016-11-14: Extension of Indication to include induction of remission, and consolidation in adult patients with newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103/μl) in combination with all trans retinoic acid (ATRA), characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-AcidReceptor-alpha (PML/RAR-alpha) gene.

Also known as

  • Brand names: Arsenol, Arsenox, Leusenox, Trisenox