Arsenic trioxide (Trisenox)

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.
Route: IV
Extravasation: irritant

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

Diseases for which it is used

• Acute promyelocytic leukemia
• Mantle cell lymphoma

Patient drug information

• Arsenic trioxide (Trisenox) package insert
• Arsenic trioxide (Trisenox) patient drug information (Chemocare)
• Arsenic trioxide (Trisenox) patient drug information (UpToDate)

History of changes in FDA indication

• 2000-09-25: Initial FDA approval for induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. (Based on PLRXAS01)
• 2018-01-12: Approved in combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. (Based on GIMEMA/DSIL APL0406)

History of changes in EMA indication

• 2002-03-05: Initial authorization

Also known as

• Brand names: Arsenol, Arsenox, Leusenox, Trisenox