Hydroxyurea (Hydrea)

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General information

Class/mechanism: Exact mechanism unclear, but data suggests that hydroxyurea inhibits DNA synthesis by inhibiting ribonucleotide reductase, which inhibits cancer cell growth. May sensitize tumors to radiation by keeping cells in the G1 phase of the cell cycle, where they are most vulnerable to radiation, and/or by interfering with DNA repair processes. Does not appear to affect RNA and protein synthesis.[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, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Diseases for which it was used

Patient drug information

History of changes in FDA indication

  • 1967-12-07: Initial FDA approval
  • Uncertain date: Approved for the treatment of resistant chronic myeloid leukemia. (Based on Koller & Miller 1986)
  • Uncertain date: Approved for the treatment of locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. (No supporting studies are cited)
  • 2017-12-21: Granted regular FDA approval (as Siklos) to reduce the frequency of painful crises and the need for blood transfusions in pediatric patients from 2 years of age and older with sickle cell anemia with recurrent moderate to severe painful crises.

History of changes in EMA indication

  • 1967-12-07: EURD

History of changes in PMDA indication

Also known as

  • Generic names: dhnp, hidroxiurea, hydroxycarbam, hydroxycarbamid, hydroxycarbamide
  • Brand names: Biosupressin, Cytodrox, Droxia, Droxiurea, Durea, Hidrea, Hondrea, Hydab, Hydrea, Hydrine, Hydrourea, Hytas, Litalir, Myelostat, Mylocel, Neodrea, Onco Carbide, Siklos, Syrea, Ureax, Xromi