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.^[1]^[2]^[3]
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.^[1]

Diseases for which it is used

Patient drug information

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 (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

References

[insert-1] 1.0 ^1.1 ^1.2 Arsenic trioxide (Trisenox) package insert

[2] Arsenic trioxide (Trisenox) package insert (locally hosted backup)

[3] Trisenox manufacturer's website

[4] Arsenic trioxide (Trisenox) patient drug information (Chemocare)

[5] Arsenic trioxide (Trisenox) patient drug information (UpToDate)

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