All-trans retinoic acid (ATRA)

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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, 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