Difference between revisions of "Decitabine (Dacogen)"
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==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. ''(Based on D-0007)'' | * 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. ''(Based on D-0007)'' | ||
| − | + | ==History of changes in EMA indication== | |
| + | *9/20/2012: Initial authorization | ||
| + | *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== | ==Patient drug information== | ||
*[https://chemocare.com/chemotherapy/drug-info/decitabine.aspx Decitabine (Dacogen) patient drug information (Chemocare)]<ref>[https://chemocare.com/chemotherapy/drug-info/decitabine.aspx Decitabine (Dacogen) patient drug information (Chemocare)]</ref> | *[https://chemocare.com/chemotherapy/drug-info/decitabine.aspx Decitabine (Dacogen) patient drug information (Chemocare)]<ref>[https://chemocare.com/chemotherapy/drug-info/decitabine.aspx Decitabine (Dacogen) patient drug information (Chemocare)]</ref> | ||
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[[Category:FDA approved in 2006]] | [[Category:FDA approved in 2006]] | ||
| + | [[Category:EMA approved in 2012]] | ||
Revision as of 12:15, 3 January 2023
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 such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
History of changes in FDA indication
- 5/2/2006: 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
- 9/20/2012: Initial authorization
- 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
- Decitabine (Dacogen) patient drug information (Chemocare)[3]
- Patient counseling information can be found in the Decitabine (Dacogen) package insert[1]
- Decitabine (Dacogen) patient drug information (UpToDate)[4]
Also known as
- Generic name: 5-aza-2'-deoxycytidine
- Brand names: Dacogen, Decima, Decita, Decitafect, Decitas, Decitex, Natdecita