Difference between revisions of "Bendamustine"
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m (Jwarner moved page Bendamustine (Bendeka) to Bendamustine: Confusion over brand name) |
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| + | '''Note: 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>''' | ||
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==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://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> | 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> | ||
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | As | + | As 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 | + | As Bendeka: |
| − | * 12/7/2015: Bendamustine (Bendeka) formulation FDA approved for | + | * 12/7/2015: Bendamustine (Bendeka) formulation FDA approved for: |
| + | **[[Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL) |Chronic lymphocytic leukemia (CLL)]] | ||
| + | **Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with [[Rituximab (Rituxan)|rituximab]] or a rituximab-containing regimen." | ||
==Also known as== | ==Also known as== | ||
| − | Bendamustine Hydrochloride, Ribomustin, SDX-105, | + | Bendamustine Hydrochloride, Bendeka, Ribomustin, SDX-105, Treakisym, Treanda |
==References== | ==References== | ||
Revision as of 14:44, 15 April 2016
Note: Previous Treanda formulation discontinued on 3/31/2016 by Teva to switch to Bendeka.[1]
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.[2][3][4][5][6][7]
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.[2]
Diseases for which it is used
- Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL)
- Cutaneous T-cell lymphoma
- Diffuse large B-cell lymphoma
- Follicular lymphoma
- Hairy cell leukemia
- Hodgkin lymphoma
- Mantle cell lymphoma
- Marginal zone lymphoma
- Multiple myeloma
- Peripheral T-cell lymphoma
- Transformed lymphoma
- Transplant conditioning regimens
- Waldenström macroglobulinemia
Patient drug information
- Bendamustine (Treanda) patient drug information (Chemocare)[8]
- Brief patient counseling information can be found in the Bendamustine (Bendeka) package insert[2]
- Brief patient counseling information can be found on page 7 of the package insert[3]
- Bendamustine (Bendeka) patient drug information (UpToDate)[9]
History of changes in FDA indication
As 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 Bendeka:
- 12/7/2015: Bendamustine (Bendeka) formulation FDA approved for:
- Chronic lymphocytic leukemia (CLL)
- 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, Bendeka, Ribomustin, SDX-105, Treakisym, Treanda
References
- ↑ MPR: Bendeka Injection Replacing Treanda Injection, accessed 4/2/2016
- ↑ 2.0 2.1 2.2 Bendamustine (Bendeka) package insert
- ↑ 3.0 3.1 Bendamustine (Treanda) package insert
- ↑ Bendamustine (Treanda) package insert (locally hosted backup)
- ↑ Bendamustine (Bendeka) package insert (locally hosted backup)
- ↑ Treanda manufacturer's website
- ↑ Bendeka manufacturer's website
- ↑ Bendamustine (Treanda) patient drug information (Chemocare)
- ↑ Bendamustine (Bendeka) patient drug information (UpToDate)
Categories:
- Drug index
- Chemotherapy
- Intravenous chemotherapy
- Vesicant chemotherapy
- Nitrogen mustards
- Alkylating agents
- Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL) medications
- Cutaneous T-cell lymphoma medications
- Diffuse large B-cell lymphoma medications
- Follicular lymphoma medications
- Hairy cell leukemia medications
- Hodgkin lymphoma medications
- Mantle cell lymphoma medications
- Marginal zone lymphoma medications
- Multiple myeloma medications
- Peripheral T-cell lymphoma medications
- Transformed lymphoma medications
- Transplant medications
- Waldenström macroglobulinemia medications
- Drugs FDA approved in 2008
- Drugs FDA approved in 2015