Difference between revisions of "Cytarabine (Ara-C)"

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==General information==
 
==General information==
Class/mechanism: Pyrimidine analog, mimics cytosine. Converted intracellularly into cytarabine-5-triphosphate (ara-CTP). Exact mechanism of action not known; believed to inhibit DNA polymerase, incorporate into DNA and RNA, and kill cells undergoing DNA synthesis (S-phase) and sometimes block cells from progressing from the G1 phase to the S-phase.<ref name="insert">[http://www.pfizer.com/files/products/uspi_cytarabine_1000mg.pdf Cytarabine (Cytosar) package insert]</ref><ref>[[Media:Cytarabine.pdf | Cytarabine (Cytosar) package insert (locally hosted backup)]]</ref>
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Class/mechanism: Pyrimidine analog, mimics cytosine. Converted intracellularly into cytarabine-5-triphosphate (ara-CTP). Exact mechanism of action not known; believed to inhibit DNA polymerase, incorporate into DNA and RNA, and kill cells undergoing DNA synthesis (S-phase) and sometimes block cells from progressing from the G1 phase to the S-phase.<ref name="insert">[http://www.pfizer.com/files/products/uspi_cytarabine_1000mg.pdf Cytarabine (Ara-C) package insert]</ref><ref>[[:File:Cytarabine.pdf | Cytarabine (Ara-C) package insert (locally hosted backup)]]</ref>
 
<br>Route: IV, IT, SC
 
<br>Route: IV, IT, SC
 
<br>Extravasation: [[irritant]] or [[neutral]], depending on reference
 
<br>Extravasation: [[irritant]] or [[neutral]], depending on reference
  
 
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>
 
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 established ''(work in progress)''==
 +
*[[Mantle cell lymphoma]]
 +
*[[Peripheral T-cell lymphoma]]
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
*[[B-cell acute lymphoblastic leukemia]]
 
 
*[[Acute myeloid leukemia]]
 
*[[Acute myeloid leukemia]]
 
*[[Acute promyelocytic leukemia]]
 
*[[Acute promyelocytic leukemia]]
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*[[Anaplastic large cell lymphoma]]
 
*[[Anaplastic large cell lymphoma]]
 
*[[Burkitt lymphoma]]
 
*[[Burkitt lymphoma]]
 +
*[[B-cell acute lymphoblastic leukemia]]
 
*[[Chronic lymphocytic leukemia]]
 
*[[Chronic lymphocytic leukemia]]
*[[Chronic myelogenous leukemia]]
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*[[Chronic myeloid leukemia]]
 
*[[CNS lymphoma]]
 
*[[CNS lymphoma]]
 
*[[Diffuse large B-cell lymphoma]]
 
*[[Diffuse large B-cell lymphoma]]
 +
*[[Follicular lymphoma]]
 
*[[HIV-associated lymphoma]]
 
*[[HIV-associated lymphoma]]
*[[Hodgkin lymphoma]]
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*[[Classical Hodgkin lymphoma]]
 
*[[Hypereosinophilic syndrome]]
 
*[[Hypereosinophilic syndrome]]
 
*[[Langerhans cell histiocytosis]]
 
*[[Langerhans cell histiocytosis]]
*[[Mantle cell lymphoma]]
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*[[Myelodysplastic syndrome]]
*[[Peripheral T-cell lymphoma]]
 
 
*[[Primary mediastinal B-cell lymphoma]]
 
*[[Primary mediastinal B-cell lymphoma]]
 
*[[T-cell acute lymphoblastic leukemia]]
 
*[[T-cell acute lymphoblastic leukemia]]
 
*[[Transformed lymphoma]]
 
*[[Transformed lymphoma]]
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 +
==Diseases for which it was used==
 +
*[[Multiple myeloma - historical|Multiple myeloma]]
  
 
==Patient drug information==
 
==Patient drug information==
*[http://chemocare.com/chemotherapy/drug-info/cytarabine.aspx Cytarabine (Cytosar) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/cytarabine.aspx Cytarabine (Cytosar) patient drug information (Chemocare)]</ref>
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*[http://www.pfizer.com/files/products/uspi_cytarabine_1000mg.pdf Cytarabine (Ara-C) package insert]<ref name="insert"></ref>
*[http://www.uptodate.com/contents/cytarabine-patient-drug-information Cytarabine (Cytosar) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/cytarabine-patient-drug-information Cytarabine (Cytosar) patient drug information (UpToDate)]</ref>
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*[https://chemocare.com/druginfo/cytarabine.aspx Cytarabine (Ara-C) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/cytarabine.aspx Cytarabine (Ara-C) patient drug information (Chemocare)]</ref>
 +
*[http://www.uptodate.com/contents/cytarabine-patient-drug-information Cytarabine (Ara-C) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/cytarabine-patient-drug-information Cytarabine (Ara-C) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
* June 1969: initial FDA approval
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*1969-06-17: initial FDA approval
 +
*1998-10-15 (oldest label available at Drugs @ FDA): indicated in combination with other approved anticancer drugs for remission induction in [[Acute myeloid leukemia|acute nonlymphocytic leukemia]] of adults and pediatric patients. ''(No supporting studies are cited)''
 +
*1998-10-15 (oldest label available at Drugs @ FDA): indicated in the treatment of [[:Category:Acute lymphoblastic leukemias|acute lymphocytic leukemia]] and the blast phase of [[Chronic myeloid leukemia|chronic myelocytic leukemia]]. ''(No supporting studies are cited)''
 +
*1998-10-15 (oldest label available at Drugs @ FDA): Intrathecal administration is indicated in the prophylaxis and treatment of [[CNS leukemia|meningeal leukemia]]. ''(No supporting studies are cited)''
 +
==History of changes in EMA indication==
 +
*2001-07-11: EURD
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==History of changes in PMDA indication==
 +
*2019-03-26: New indication for the [[Cellular_therapy_conditioning_regimens|treatment prior to tumor-specific T-cell infusion therapy]].
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*2023-05-25: New indication and a new dosage for the treatment of [[:Category:Acute leukemias|acute leukemia]].
  
 
==Also known as==
 
==Also known as==
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|Cytosar-U
 
|Cytosar-U
 
|Cytrosar
 
|Cytrosar
|Depocyt
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|Erbabin
 
|-
 
|-
|Depocyte
 
|Erbabin
 
 
|Erpalfa
 
|Erpalfa
 
|Fauldcita
 
|Fauldcita
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|Iretin
 
|Iretin
 
|Laracit
 
|Laracit
|-
 
 
|Medsara
 
|Medsara
 
|Novutrax
 
|Novutrax
 +
|-
 
|Remcyta
 
|Remcyta
 
|Starasid
 
|Starasid
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|Tabine
 
|Tabine
 
|Udicil
 
|Udicil
|
 
 
|}
 
|}
  
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[[Category:Subcutaneous medications]]
 
[[Category:Subcutaneous medications]]
 
[[Category:Irritant]]
 
[[Category:Irritant]]
[[Category:Neutral chemotherapy]]
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[[Category:Neutral]]
  
 
[[Category:Antimetabolites]]
 
[[Category:Antimetabolites]]
[[Category:Deoxycytidine analogues]]
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[[Category:Deoxycytidine analogs]]
  
 
[[Category:B-cell acute lymphoblastic leukemia medications]]
 
[[Category:B-cell acute lymphoblastic leukemia medications]]
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[[Category:Burkitt lymphoma medications]]
 
[[Category:Burkitt lymphoma medications]]
 
[[Category:Chronic lymphocytic leukemia medications]]
 
[[Category:Chronic lymphocytic leukemia medications]]
[[Category:Chronic myelogenous leukemia medications]]
+
[[Category:Chronic myeloid leukemia medications]]
 
[[Category:CNS lymphoma medications]]
 
[[Category:CNS lymphoma medications]]
 
[[Category:Diffuse large B-cell lymphoma medications]]
 
[[Category:Diffuse large B-cell lymphoma medications]]
 +
[[Category:Follicular lymphoma medications]]
 
[[Category:HIV-associated lymphoma medications]]
 
[[Category:HIV-associated lymphoma medications]]
[[Category:Hodgkin lymphoma medications]]
+
[[Category:Classical Hodgkin lymphoma medications]]
 
[[Category:Hypereosinophilic syndrome medications]]
 
[[Category:Hypereosinophilic syndrome medications]]
 
[[Category:Langerhans cell histiocytosis medications]]
 
[[Category:Langerhans cell histiocytosis medications]]
 
[[Category:Mantle cell lymphoma medications]]
 
[[Category:Mantle cell lymphoma medications]]
 +
[[Category:Myelodysplastic syndrome medications]]
 
[[Category:Peripheral T-cell lymphoma medications]]
 
[[Category:Peripheral T-cell lymphoma medications]]
 
[[Category:Primary mediastinal B-cell lymphoma medications]]
 
[[Category:Primary mediastinal B-cell lymphoma medications]]
 
[[Category:T-cell acute lymphoblastic leukemia medications]]
 
[[Category:T-cell acute lymphoblastic leukemia medications]]
 
[[Category:Transformed lymphoma medications]]
 
[[Category:Transformed lymphoma medications]]
 +
 +
[[Category:Multiple myeloma medications (historic)]]
  
 
[[Category:FDA approved in 1969]]
 
[[Category:FDA approved in 1969]]
 +
[[Category:EMA approved in 2001]]
 
[[Category:WHO Essential Cancer Medicine]]
 
[[Category:WHO Essential Cancer Medicine]]

Revision as of 03:43, 1 June 2024

General information

Class/mechanism: Pyrimidine analog, mimics cytosine. Converted intracellularly into cytarabine-5-triphosphate (ara-CTP). Exact mechanism of action not known; believed to inhibit DNA polymerase, incorporate into DNA and RNA, and kill cells undergoing DNA synthesis (S-phase) and sometimes block cells from progressing from the G1 phase to the S-phase.[1][2]
Route: IV, IT, SC
Extravasation: irritant or neutral, depending on reference

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 established (work in progress)

Diseases for which it is used

Diseases for which it was used

Patient drug information

History of changes in FDA indication

  • 1969-06-17: initial FDA approval
  • 1998-10-15 (oldest label available at Drugs @ FDA): indicated in combination with other approved anticancer drugs for remission induction in acute nonlymphocytic leukemia of adults and pediatric patients. (No supporting studies are cited)
  • 1998-10-15 (oldest label available at Drugs @ FDA): indicated in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. (No supporting studies are cited)
  • 1998-10-15 (oldest label available at Drugs @ FDA): Intrathecal administration is indicated in the prophylaxis and treatment of meningeal leukemia. (No supporting studies are cited)

History of changes in EMA indication

  • 2001-07-11: EURD

History of changes in PMDA indication

Also known as

  • Generic names: Ara-C, arabinosylcytosine, arabinofuranosyl cytidine, cytosine arabinoside
  • Brand names:
Synonyms
Alcysten Alexan ARA Arabine Arabitin Aracitin Aracytin Aracytine
Citagenin Citaloxan Citarabin Citarabina Citarabins Citarax Cylocide Cytarabin
Cytarabins Cytarabinum Cytarbel Cytarine Cytosar Cytosar-U Cytrosar Erbabin
Erpalfa Fauldcita Groven Ifarab Iretin Laracit Medsara Novutrax
Remcyta Starasid Tabin Tabine Udicil

References