Difference between revisions of "Arsenic trioxide (Trisenox)"
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==General information== | ==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.<ref name="insert">[ | + | Class/mechanism: Causes damage or degradation of PML-RAR alpha fusion protein, causes apoptosis-type changes in NB4 human promyelocytic leukemia cells in vitro.<ref name="insert">[https://www.trisenox.com/globalassets/trisenoxhcp/trisenox-prescribing-information.pdf Arsenic trioxide (Trisenox) package insert]</ref><ref>[[:File:Arsenictrioxide.pdf | Arsenic trioxide (Trisenox) package insert (locally hosted backup)]]</ref><ref>[https://www.trisenox.com/ Trisenox manufacturer's website]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: [[irritant]] | <br>Extravasation: [[irritant]] | ||
| Line 11: | Line 11: | ||
==Patient drug information== | ==Patient drug information== | ||
| − | *[ | + | *[https://www.trisenox.com/globalassets/trisenoxhcp/trisenox-prescribing-information.pdf Arsenic trioxide (Trisenox) package insert]<ref name="insert"></ref> |
| + | *[https://chemocare.com/druginfo/arsenic-trioxide.aspx Arsenic trioxide (Trisenox) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/arsenic-trioxide.aspx Arsenic trioxide (Trisenox) patient drug information (Chemocare)]</ref> | ||
*[http://www.uptodate.com/contents/arsenic-trioxide-patient-drug-information Arsenic trioxide (Trisenox) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/arsenic-trioxide-patient-drug-information Arsenic trioxide (Trisenox) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/arsenic-trioxide-patient-drug-information Arsenic trioxide (Trisenox) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/arsenic-trioxide-patient-drug-information Arsenic trioxide (Trisenox) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2000-09-25: 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)'' |
| + | *2018-01-12: 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== | ||
| + | *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 leukemia|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== | ==References== | ||
<references/> | <references/> | ||
| − | [[Category: | + | [[Category:Drugs]] |
| − | + | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| − | [[Category: | + | [[Category:Mutation-specific medications]] |
| + | |||
| + | [[Category:Arsenic compound]] | ||
| + | [[Category:Targeted therapeutic]] | ||
[[Category:Acute promyelocytic leukemia medications]] | [[Category:Acute promyelocytic leukemia medications]] | ||
[[Category:Mantle cell lymphoma medications]] | [[Category:Mantle cell lymphoma medications]] | ||
| − | [[Category: | + | [[Category:FDA approved in 2000]] |
| + | [[Category:EMA approved in 2002]] | ||
| + | [[Category:WHO Essential Cancer Medicine]] | ||
Latest revision as of 00:47, 9 September 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
- 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