Difference between revisions of "All-trans retinoic acid (ATRA)"

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==General information==
 
==General information==
Class/mechanism: Retinoid, induces maturation/differentiation of [[Acute promyelocytic leukemia|acute promyelocytic leukemia (APL)]] cells. Exact mechanism unknown.<ref name="insert">[http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20438s004lbl.pdf Tretinoin (Vesanoid) package insert]</ref><ref>[[Media:Tretinoin.pdf | Tretinoin (Vesanoid) package insert (locally hosted backup)]]</ref>
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Class/mechanism: Retinoid, induces maturation/differentiation of [[Acute promyelocytic leukemia|acute promyelocytic leukemia (APL)]] cells. Exact mechanism unknown.<ref name="insert">[https://xediton.com/wp-content/uploads/2019/06/VESANOID-Prescribing-Information-compressed.pdf Tretinoin (Vesanoid) package insert]</ref><ref>[[:File:Tretinoin.pdf | Tretinoin (Vesanoid) package insert (locally hosted backup)]]</ref>
 
<br>Route: PO
 
<br>Route: PO
 
<br>Extravasation: n/a
 
<br>Extravasation: n/a
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==Diseases for which it is used==
 
==Diseases for which it is used==
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*[[Acute myeloid leukemia, NPM1-mutated]]
 
*[[Acute promyelocytic leukemia]]
 
*[[Acute promyelocytic leukemia]]
 
*[[Immune thrombocytopenia (ITP)]]
 
*[[Immune thrombocytopenia (ITP)]]
  
 
==Patient drug information==
 
==Patient drug information==
*[http://chemocare.com/chemotherapy/drug-info/Tretinoin.aspx Tretinoin (Vesanoid) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/Tretinoin.aspx Tretinoin (Vesanoid) patient drug information (Chemocare)]</ref>
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*[https://chemocare.com/druginfo/Tretinoin.aspx Tretinoin (Vesanoid) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/Tretinoin.aspx Tretinoin (Vesanoid) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/all-trans-retinoic-acid-tretinoin-patient-drug-information Tretinoin (Vesanoid) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/all-trans-retinoic-acid-tretinoin-patient-drug-information Tretinoin (Vesanoid) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/all-trans-retinoic-acid-tretinoin-patient-drug-information Tretinoin (Vesanoid) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/all-trans-retinoic-acid-tretinoin-patient-drug-information Tretinoin (Vesanoid) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
*11/22/1995: Initial FDA approval  
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*1995-11-22: Initial FDA approval  
*7/19/2004: 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#15.3B17|t(15;17) translocation]] and/or the presence of the [[Biomarkers#PML-RAR.CE.B1|PML/RARα gene]] who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated.
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*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.
 
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==History of changes in EMA indication==
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*1994-03-31: EURD
 
==Also known as==
 
==Also known as==
 
*'''Generic names:''' all-trans retinoic acid, ATRA, tretinoin
 
*'''Generic names:''' all-trans retinoic acid, ATRA, tretinoin
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[[Category:Retinoids]]
 
[[Category:Retinoids]]
  
 +
[[Category:Acute myeloid leukemia medications]]
 
[[Category:Acute promyelocytic leukemia medications]]
 
[[Category:Acute promyelocytic leukemia medications]]
 
[[Category:Immune thrombocytopenia medications]]
 
[[Category:Immune thrombocytopenia medications]]
  
 
[[Category:FDA approved in 1995]]
 
[[Category:FDA approved in 1995]]
 +
[[Category:EMA approved in 1994]]
 
[[Category:WHO Essential Cancer Medicine]]
 
[[Category:WHO Essential Cancer Medicine]]

Latest revision as of 23:13, 2 September 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

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

References