Idarubicin (Idamycin)

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General information

Class/mechanism: Anthracycline analog of Daunorubicin (Cerubidine), binds and intercalates between DNA base pairs. Inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II complex, resulting in single and double strand DNA breaks. May also inhibit polymerase activity and trigger free radical damage to DNA. In comparison to other anthracyclines, idarubicin lacks a methoxy group at position 4 of the anthracycline structure, which results in it having high lipophilicity and an increased rate of cellular uptake compared with other anthracyclines.[1][2][3][4]
Route: IV
Extravasation: vesicant

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, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

  • 1990-09-27: Initial FDA approval in combination with other approved antileukemic drugs for the treatment of acute myeloid leukemia (AML) in adults. (Based on L-19 Protocol, Mandelli et al. 1991, Vogler et al. 1992, Wiernik et al. 1992)
  • 2014-12-04 (most recent label available on Drugs @ FDA): "in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American- British (FAB) classifications M1 through M7."

History of changes in EMA indication

  • 1989-11-29: EURD

Also known as

  • Generic names: idarubicin comp, idarubicin hydrochloride
  • Brand names: Idamycin, Idaru, Ondarubin, Zavedos, Zavedose