Arsenic trioxide (Trisenox)
Class/mechanism: Causes damage or degradation of PML-RAR alpha fusion protein, causes apoptosis-type changes in NB4 human promyelocytic leukemia cells in vitro.
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Diseases for which it is used
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 (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