Difference between revisions of "Bendamustine"

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search
m (Text replacement - "Treanda" to "Bendeka")
Line 1: Line 1:
 
==General information==
 
==General information==
−
Class/mechanism: Nitrogen mustard, alkylator; bifunctional mechlorethamine derivative containing a purine-like benzimidazole ring which forms electrophilic alkyl groups, resulting in interstrand DNA crosslinks, leading to cell death via several pathways in both quiescent and dividing cells.<ref name="insert">[http://www.treanda.com/pdf/TREANDA_final_PI.pdf Bendamustine (Bendeka) package insert]</ref><ref>[[Media:Bendamustine.pdf | Bendamustine (Bendeka) package insert (locally hosted backup)]]</ref><ref>[http://treanda.com/ Bendeka manufacturer's website]</ref>
+
Class/mechanism: Nitrogen mustard, alkylator; bifunctional mechlorethamine derivative containing a purine-like benzimidazole ring which forms electrophilic alkyl groups, resulting in interstrand DNA crosslinks, leading to cell death via several pathways in both quiescent and dividing cells.<ref name="insert">[http://bendeka.com/PrescribingInformation.PDF Bendamustine (Bendeka) package insert]</ref><ref name="treanda">[http://www.treanda.com/pdf/TREANDA_final_PI.pdf Bendamustine (Treanda) package insert]</ref><ref>[[Media:Bendamustine.pdf | Bendamustine (Treanda) package insert (locally hosted backup)]]</ref><ref>[[Media:Bendamustinebendeka.pdf | Bendamustine (Bendeka) package insert (locally hosted backup)]]</ref><ref>[http://treanda.com/ Treanda manufacturer's website]</ref><ref>[http://bendeka.com/ Bendeka manufacturer's website]</ref>
 
<br>Route: IV
 
<br>Route: IV
 
<br>Extravasation: [[vesicant]]
 
<br>Extravasation: [[vesicant]]
Line 22: Line 22:
  
 
==Patient drug information==
 
==Patient drug information==
−
*[http://chemocare.com/chemotherapy/drug-info/bendamustine.aspx Bendamustine (Bendeka) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/bendamustine.aspx Bendamustine (Bendeka) patient drug information (Chemocare)]</ref>
+
*[http://chemocare.com/chemotherapy/drug-info/bendamustine.aspx Bendamustine (Treanda) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/bendamustine.aspx Bendamustine (Treanda) patient drug information (Chemocare)]</ref>
−
*Brief patient counseling information can be found on [http://www.treanda.com/pdf/TREANDA_final_PI.pdf#page=7 page 7 of the package insert]<ref name="insert"></ref>
+
*Brief patient counseling information can be found in [http://bendeka.com/PrescribingInformation.PDF the Bendamustine (Bendeka) package insert]<ref name="insert"></ref>
 +
*Brief patient counseling information can be found on [http://www.treanda.com/pdf/TREANDA_final_PI.pdf#page=7 page 7 of the package insert]<ref name="treanda"></ref>
 
*[http://www.uptodate.com/contents/bendamustine-patient-drug-information Bendamustine (Bendeka) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/bendamustine-patient-drug-information Bendamustine (Bendeka) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/bendamustine-patient-drug-information Bendamustine (Bendeka) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/bendamustine-patient-drug-information Bendamustine (Bendeka) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
 +
As Bendamustine (Treanda):
 
* 3/20/2008: Initial FDA approval "for the treatment of patients with [[Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL) | chronic lymphocytic leukemia (CLL)]]."
 
* 3/20/2008: Initial FDA approval "for the treatment of patients with [[Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL) | chronic lymphocytic leukemia (CLL)]]."
 
* 4/22/2009: Additional indication for "Indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within six months of treatment with [[Rituximab (Rituxan) | rituximab]] or a rituximab­ containing regimen."
 
* 4/22/2009: Additional indication for "Indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within six months of treatment with [[Rituximab (Rituxan) | rituximab]] or a rituximab­ containing regimen."
 +
As Bendamustine (Bendeka):
 +
* 12/7/2015: Bendamustine (Bendeka) formulation FDA approved for "Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen."
  
 
==Also known as==
 
==Also known as==
−
Bendamustine Hydrochloride, Ribomustin, SDX-105, or Treakisym.
+
Bendamustine Hydrochloride, Ribomustin, SDX-105, or Treakisym. Previous Treanda formulation discontinued on 3/31/2016 by Teva to switch to Bendeka.<ref>[http://www.empr.com/news/bendeka-injection-replacing-treanda-injection/article/467845/ MPR: Bendeka Injection Replacing Treanda Injection], accessed 4/2/2016</ref>
  
 
==References==
 
==References==
Line 59: Line 63:
  
 
[[Category:Drugs FDA approved in 2008]]
 
[[Category:Drugs FDA approved in 2008]]
 +
[[Category:Drugs FDA approved in 2015]]

Revision as of 21:43, 2 April 2016

General information

Class/mechanism: Nitrogen mustard, alkylator; bifunctional mechlorethamine derivative containing a purine-like benzimidazole ring which forms electrophilic alkyl groups, resulting in interstrand DNA crosslinks, leading to cell death via several pathways in both quiescent and dividing cells.[1][2][3][4][5][6]
Route: IV
Extravasation: vesicant

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, Medscape, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

As Bendamustine (Treanda):

  • 3/20/2008: Initial FDA approval "for the treatment of patients with chronic lymphocytic leukemia (CLL)."
  • 4/22/2009: Additional indication for "Indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab­ containing regimen."

As Bendamustine (Bendeka):

  • 12/7/2015: Bendamustine (Bendeka) formulation FDA approved for "Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen."

Also known as

Bendamustine Hydrochloride, Ribomustin, SDX-105, or Treakisym. Previous Treanda formulation discontinued on 3/31/2016 by Teva to switch to Bendeka.[9]

References

  1. ↑ 1.0 1.1 1.2 Bendamustine (Bendeka) package insert
  2. ↑ 2.0 2.1 Bendamustine (Treanda) package insert
  3. ↑ Bendamustine (Treanda) package insert (locally hosted backup)
  4. ↑ Bendamustine (Bendeka) package insert (locally hosted backup)
  5. ↑ Treanda manufacturer's website
  6. ↑ Bendeka manufacturer's website
  7. ↑ Bendamustine (Treanda) patient drug information (Chemocare)
  8. ↑ Bendamustine (Bendeka) patient drug information (UpToDate)
  9. ↑ MPR: Bendeka Injection Replacing Treanda Injection, accessed 4/2/2016
Retrieved from "https://hemonc.org/w/index.php?title=Bendamustine&oldid=10615"