Difference between revisions of "Decitabine (Dacogen)"

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m (Text replacement - "please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [https://online.lexi.com/lco/action/login UpToDate Lexidrug], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information" to "please refer to your preferred pharmacopeias or the prescribing information")
 
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Also known as 5-aza-2'-deoxycytidine.
 
 
 
==General information==
 
==General information==
Class/mechanism: Pyrimidine/cytosine analog, DNA hypomethylating agent. Incorporates into DNA and inhibits DNA methyltransferase, causing DNA hypomethylation, which results in cellular differentiation or apoptosis.<ref name="insert">[http://us.eisai.com/pdf_files/Dacogen_PI.pdf Decitabine (Dacogen) package insert]</ref><ref>[[Media:Decitabine.pdf | Decitabine (Dacogen) package insert (locally hosted backup)]]</ref><ref>[http://dacogen.com Dacogen manufacturer's website]</ref>
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Class/mechanism: Pyrimidine/cytosine analog, DNA hypomethylating agent. Incorporates into DNA and inhibits DNA methyltransferase, causing DNA hypomethylation, which results in cellular differentiation or apoptosis.<ref name="insert">[https://www.otsuka-us.com/media/static/DACOGEN-PI.pdf Decitabine (Dacogen) package insert]</ref><ref>[[:File:Decitabine.pdf | Decitabine (Dacogen) package insert (locally hosted backup)]]</ref>
 
<br>Route: IV
 
<br>Route: IV
 
<br>Extravasation: no information
 
<br>Extravasation: no information
  
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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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 or the prescribing information.<ref name="insert"></ref>  
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
 
*[[Acute myeloid leukemia]]
 
*[[Acute myeloid leukemia]]
 +
*[[Chronic myelomonocytic leukemia]]
 
*[[Myelodysplastic syndrome]]
 
*[[Myelodysplastic syndrome]]
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
* 5/2/2006: Initial approval for treatment of patients with [[Myelodysplastic syndrome | myelodysplastic syndromes (MDS)]] including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
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* 2006-05-02: Initial approval for treatment of patients with [[Myelodysplastic syndrome | myelodysplastic syndromes (MDS)]] including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. ''(Based on D-0007)''
 +
==History of changes in EMA indication==
 +
*2012-09-20: Initial authorization
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*Uncertain date: Indicated for treatment of adult patients with newly diagnosed de novo or secondary [[Acute myeloid leukemia|acute myeloid leukaemia (AML)]], according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy.
  
 
==Patient drug information==
 
==Patient drug information==
*[http://chemocare.com/chemotherapy/drug-info/decitabine.aspx Decitabine (Dacogen) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/decitabine.aspx Decitabine (Dacogen) patient drug information (Chemocare)]</ref>
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*[https://chemocare.com/druginfo/decitabine.aspx Decitabine (Dacogen) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/decitabine.aspx Decitabine (Dacogen) patient drug information (Chemocare)]</ref>
*Brief patient counseling information can be found on [http://us.eisai.com/pdf_files/Dacogen_PI.pdf#page=8 pages 8-9 of the Decitabine (Dacogen) package insert]<ref name="insert"></ref>
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*Patient counseling information can be found in the [https://www.otsuka-us.com/media/static/DACOGEN-PI.pdf Decitabine (Dacogen) package insert]<ref name="insert"></ref>
 
*[http://www.uptodate.com/contents/decitabine-patient-drug-information Decitabine (Dacogen) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/decitabine-patient-drug-information Decitabine (Dacogen) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/decitabine-patient-drug-information Decitabine (Dacogen) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/decitabine-patient-drug-information Decitabine (Dacogen) patient drug information (UpToDate)]</ref>
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 +
==Also known as==
 +
*'''Generic name:''' 5-aza-2'-deoxycytidine
 +
*'''Brand names:''' Dacogen, Decima, Decita, Decitafect, Decitas, Decitex, Natdecita
  
 
==References==
 
==References==
 
<references/>
 
<references/>
  
[[Category:Drug index]]
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[[Category:Drugs]]
[[Category:Chemotherapy]]
 
 
[[Category:Intravenous medications]]
 
[[Category:Intravenous medications]]
  
[[Category:Hypomethylating agents]]
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[[Category:DNA methyltransferase inhibitors]]
[[Category:Pyrimidine analogues]]
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[[Category:Pyrimidine analogs]]
  
 
[[Category:Acute myeloid leukemia medications]]
 
[[Category:Acute myeloid leukemia medications]]
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[[Category:Chronic myelomonocytic leukemia medications]]
 
[[Category:Myelodysplastic syndrome medications]]
 
[[Category:Myelodysplastic syndrome medications]]
  
[[Category:Drugs FDA approved in 2006]]
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[[Category:FDA approved in 2006]]
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[[Category:EMA approved in 2012]]

Latest revision as of 01:02, 29 June 2024

General information

Class/mechanism: Pyrimidine/cytosine analog, DNA hypomethylating agent. Incorporates into DNA and inhibits DNA methyltransferase, causing DNA hypomethylation, which results in cellular differentiation or apoptosis.[1][2]
Route: IV
Extravasation: no information

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 or the prescribing information.[1]

Diseases for which it is used

History of changes in FDA indication

  • 2006-05-02: Initial approval for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. (Based on D-0007)

History of changes in EMA indication

  • 2012-09-20: Initial authorization
  • Uncertain date: Indicated for treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy.

Patient drug information

Also known as

  • Generic name: 5-aza-2'-deoxycytidine
  • Brand names: Dacogen, Decima, Decita, Decitafect, Decitas, Decitex, Natdecita

References