Difference between revisions of "Hydroxyurea (Hydrea)"

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==General information==
 
==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.<ref name="insert">[http://packageinserts.bms.com/pi/pi_hydrea.pdf Hydroxyurea (Hydrea) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/hydroxyurea.pdf Hydroxyurea (Hydrea) package insert (locally hosted backup)]</ref>
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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.<ref name="insert">[http://packageinserts.bms.com/pi/pi_hydrea.pdf Hydroxyurea (Hydrea) package insert]</ref><ref>[[:File:Hydroxyurea.pdf | Hydroxyurea (Hydrea) package insert (locally hosted backup)]]</ref>
 
<br>Route: PO
 
<br>Route: PO
 
<br>Extravasation: n/a
 
<br>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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the package insert<ref name="insert"></ref>.
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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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>  
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==Diseases for which it is used==
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*[[Acute myeloid leukemia]]
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*[[Acute promyelocytic leukemia]]
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*[[Cervical cancer]]
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*[[Chronic myeloid leukemia]]
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*[[Essential thrombocythemia]]
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*[[Glioblastoma]]
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*[[Head and neck cancer]]
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*[[Hypereosinophilic syndrome]]
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*[[Myelofibrosis]]
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*[[Polycythemia vera]]
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*[[Sickle cell anemia]]
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==Diseases for which it was used==
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*[[Melanoma - historical|Melanoma]]
  
 
==Patient drug information==
 
==Patient drug information==
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*Brief patient counseling information can be found in the [http://packageinserts.bms.com/pi/pi_hydrea.pdf Hydroxyurea (Hydrea) package insert]<ref name="insert"></ref>
 
*[http://chemocare.com/bio/hydroxyurea.asp Hydroxyurea (Hydrea) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/hydroxyurea.asp Hydroxyurea (Hydrea) patient drug information (Chemocare)]</ref>
 
*[http://chemocare.com/bio/hydroxyurea.asp Hydroxyurea (Hydrea) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/hydroxyurea.asp Hydroxyurea (Hydrea) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/hydroxyurea-patient-drug-information Hydroxyurea (Hydrea) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/hydroxyurea-patient-drug-information Hydroxyurea (Hydrea) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/hydroxyurea-patient-drug-information Hydroxyurea (Hydrea) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/hydroxyurea-patient-drug-information Hydroxyurea (Hydrea) patient drug information (UpToDate)]</ref>
  
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==History of changes in FDA indication==
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* 1967-12-07: Initial FDA approval
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*Uncertain date: Approved for the treatment of resistant [[chronic myeloid leukemia]]. ''(Based on Koller & Miller 1986)''
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*Uncertain date: Approved for the treatment of locally advanced [[Head and neck cancer|squamous cell carcinomas of the head and neck]] (excluding the lip) in combination with chemoradiation. ''(No supporting studies are cited)''
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* 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.
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==History of changes in EMA indication==
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*1967-12-07: EURD
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==History of changes in PMDA indication==
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*2013-03-25: New additional indications for the treatment of [[essential thrombocythemia]] and [[polycythemia vera]].
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==Also known as==
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*'''Generic names:''' dhnp, hidroxiurea, hydroxycarbam, hydroxycarbamid, hydroxycarbamide
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*'''Brand names:''' Biosupressin, Cytodrox, Droxia, Droxiurea, Durea, Hidrea, Hondrea, Hydab, Hydrea, Hydrine, Hydrourea, Hytas, Litalir, Myelostat, Mylocel, Neodrea, Onco Carbide, Siklos, Syrea, Ureax, Xromi
 
==References==
 
==References==
 
<references/>
 
<references/>
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[[Category:Drugs]]
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[[Category:Oral medications]]
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[[Category:Human DNA synthesis inhibitors]]
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[[Category:Acute myeloid leukemia medications]]
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[[Category:Acute promyelocytic leukemia medications]]
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[[Category:Cervical cancer medications]]
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[[Category:Chronic myeloid leukemia medications]]
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[[Category:Essential thrombocythemia medications]]
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[[Category:Glioblastoma medications]]
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[[Category:Head and neck cancer medications]]
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[[Category:Hypereosinophilic syndrome medications]]
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[[Category:Myelofibrosis medications]]
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[[Category:Polycythemia vera medications]]
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[[Category:Sickle cell anemia medications]]
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[[Category:Melanoma medications (historic)]]
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[[Category:FDA approved in 1967]]
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[[Category:EMA approved in 1967]]
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[[Category:WHO Essential Cancer Medicine]]

Revision as of 02:44, 22 November 2023

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

References