Difference between revisions of "All-trans retinoic acid (ATRA)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*1995-11-22: Initial FDA approval | *1995-11-22: Initial FDA approval | ||
| − | *2004-07-19: FDA approved for the induction of remission in patients with [[Acute promyelocytic leukemia|acute promyelocytic leukemia (APL)]], French-American-British (FAB) classification M3 (including the M3 variant), characterized by the presence of the [[Biomarkers#t.2815.3B17.29|t(15;17) translocation]] and/or the presence of the [[Biomarkers#PML-RARA|PML/ | + | *2004-07-19: FDA approved for the induction of remission in patients with [[Acute promyelocytic leukemia|acute promyelocytic leukemia (APL)]], French-American-British (FAB) classification M3 (including the M3 variant), characterized by the presence of the [[Biomarkers#t.2815.3B17.29|t(15;17) translocation]] and/or the presence of the [[Biomarkers#PML-RARA|PML/RARA gene]] who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated. |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*1994-03-31: EURD | *1994-03-31: EURD | ||
Revision as of 00:30, 1 August 2023
General information
Class/mechanism: Retinoid, induces maturation/differentiation of acute promyelocytic leukemia (APL) cells. Exact mechanism unknown.[1][2]
Route: PO
Extravasation: n/a
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
- Tretinoin (Vesanoid) patient drug information (Chemocare)[3]
- Tretinoin (Vesanoid) patient drug information (UpToDate)[4]
History of changes in FDA indication
- 1995-11-22: Initial FDA approval
- 2004-07-19: FDA approved for the induction of remission in patients with acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 (including the M3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the PML/RARA gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated.
History of changes in EMA indication
- 1994-03-31: EURD
Also known as
- Generic names: all-trans retinoic acid, ATRA, tretinoin
- Brand names: CA ATRA, Ves-ATRA, Vesanoid