Difference between revisions of "Arsenic trioxide (Trisenox)"
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*9/25/2000: Initial FDA approval for induction of remission and consolidation in patients with [[Acute promyelocytic leukemia | acute promyelocytic leukemia (APL)]] who are refractory to, or have relapsed from, [[:Category:Retinoids|retinoid]] and [[:Category:Anthracyclines|anthracycline]] chemotherapy, and whose APL is characterized by the presence of the [[Biomarkers#t.2815.3B17.29|t(15;17) translocation]] or [[Biomarkers#PML-RARA|PML/RAR-alpha gene expression]]. ''(Based on PLRXAS01)'' | *9/25/2000: Initial FDA approval for induction of remission and consolidation in patients with [[Acute promyelocytic leukemia | acute promyelocytic leukemia (APL)]] who are refractory to, or have relapsed from, [[:Category:Retinoids|retinoid]] and [[:Category:Anthracyclines|anthracycline]] chemotherapy, and whose APL is characterized by the presence of the [[Biomarkers#t.2815.3B17.29|t(15;17) translocation]] or [[Biomarkers#PML-RARA|PML/RAR-alpha gene expression]]. ''(Based on PLRXAS01)'' | ||
*1/12/2018: Approved in combination with tretinoin for treatment of adults with newly-diagnosed low-risk [[Acute promyelocytic leukemia |acute promyelocytic leukemia (APL)]] whose APL is characterized by the presence of the [[Biomarkers#t.2815.3B17.29|t(15;17) translocation]] or [[Biomarkers#PML-RARA|PML/RAR-alpha gene expression]]. ''(Based on GIMEMA/DSIL APL0406)'' | *1/12/2018: Approved in combination with tretinoin for treatment of adults with newly-diagnosed low-risk [[Acute promyelocytic leukemia |acute promyelocytic leukemia (APL)]] whose APL is characterized by the presence of the [[Biomarkers#t.2815.3B17.29|t(15;17) translocation]] or [[Biomarkers#PML-RARA|PML/RAR-alpha gene expression]]. ''(Based on GIMEMA/DSIL APL0406)'' | ||
| − | + | ==History of changes in EMA indication== | |
| + | *3/5/2002: Initial authorization | ||
==Also known as== | ==Also known as== | ||
*'''Brand names:''' Arsenol, Arsenox, Leusenox, Trisenox | *'''Brand names:''' Arsenol, Arsenox, Leusenox, Trisenox | ||
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[[Category:FDA approved in 2000]] | [[Category:FDA approved in 2000]] | ||
| + | [[Category:EMA approved in 2002]] | ||
[[Category:WHO Essential Cancer Medicine]] | [[Category:WHO Essential Cancer Medicine]] | ||
Revision as of 14:14, 2 January 2023
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
- Arsenic trioxide (Trisenox) package insert[1]
- Arsenic trioxide (Trisenox) patient drug information (Chemocare)[4]
- Arsenic trioxide (Trisenox) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 9/25/2000: 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)
- 1/12/2018: 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
- 3/5/2002: Initial authorization
Also known as
- Brand names: Arsenol, Arsenox, Leusenox, Trisenox