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>[[:File:Cytarabine.pdf | Cytarabine (Cytosar) package insert (locally hosted backup)]]</ref>
+
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
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*[[B-cell acute lymphoblastic leukemia]]
 
*[[B-cell acute lymphoblastic leukemia]]
 
*[[Chronic lymphocytic leukemia]]
 
*[[Chronic lymphocytic leukemia]]
*[[Chronic myelogenous leukemia]]
+
*[[Chronic myeloid leukemia]]
 
*[[CNS lymphoma]]
 
*[[CNS lymphoma]]
 
*[[Diffuse large B-cell lymphoma]]
 
*[[Diffuse large B-cell lymphoma]]
 
*[[Follicular lymphoma]]
 
*[[Follicular lymphoma]]
 
*[[HIV-associated lymphoma]]
 
*[[HIV-associated lymphoma]]
*[[Hodgkin lymphoma]]
+
*[[Classical Hodgkin lymphoma]]
 
*[[Hypereosinophilic syndrome]]
 
*[[Hypereosinophilic syndrome]]
 
*[[Langerhans cell histiocytosis]]
 
*[[Langerhans cell histiocytosis]]
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==Patient drug information==
 
==Patient drug information==
*[http://www.pfizer.com/files/products/uspi_cytarabine_1000mg.pdf Cytarabine (Cytosar) package insert]<ref name="insert"></ref>
+
*[http://www.pfizer.com/files/products/uspi_cytarabine_1000mg.pdf Cytarabine (Ara-C) package insert]<ref name="insert"></ref>
*[https://chemocare.com/chemotherapy/drug-info/cytarabine.aspx Cytarabine (Cytosar) patient drug information (Chemocare)]<ref>[https://chemocare.com/chemotherapy/drug-info/cytarabine.aspx Cytarabine (Cytosar) patient drug information (Chemocare)]</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 (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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*[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==
* 6/17/1969: initial FDA approval
+
*1969-06-17: initial FDA approval
*10/15/1998 (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. It has also been found useful in the treatment of [[:Category:Acute lymphoblastic leukemias|acute lymphocytic leukemia]] and the blast phase of [[Chronic myelogenous leukemia|chronic myelocytic leukemia]]. Intrathecal administration is indicated in the prophylaxis and treatment of [[CNS leukemia|meningeal leukemia]].
+
*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
 +
==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]].
 +
*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
+
|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:Antimetabolites]]
 
[[Category:Antimetabolites]]
[[Category:Deoxycytidine analogues]]
+
[[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: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]]
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[[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