Bendamustine

Note: Previous Treanda formulation discontinued on 2016-03-31 by Teva to switch to Bendeka.MPR: Bendeka Injection Replacing Treanda Injection, accessed 2016-04-02
==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.Bendamustine (Bendeka) package insertBendamustine (Treanda) package insert Bendamustine (Treanda) package insert (locally hosted backup) Bendamustine (Bendeka) package insert (locally hosted backup)Treanda manufacturer's websiteBendeka manufacturer's website
Route: IV
Extravasation: irritant (usually), vesicant (rare)
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, UpToDate Lexidrug, Medscape, or the prescribing information.
==Diseases for which it is established (work in progress)==
*Indolent lymphoma
*Mantle cell lymphoma
==Diseases for which it is used==
*B-cell lymphoma of mucosa-associated lymphoid tissue
*Chronic lymphocytic leukemia
*Cold agglutinin disease
*Cutaneous T-cell lymphoma
*Diffuse large B-cell lymphoma
*Follicular lymphoma
*Hairy cell leukemia
*Classical Hodgkin lymphoma
*Light-chain (AL) amyloidosis
*Multiple myeloma
*Peripheral T-cell lymphoma
*Small cell lung cancer
*T-cell prolymphocytic leukemia
*Transformed lymphoma
*Waldenström macroglobulinemia
==Patient drug information==
*Bendamustine (Treanda) patient drug information (Chemocare)Bendamustine (Treanda) patient drug information (Chemocare)
*Brief patient counseling information can be found in the Bendamustine (Bendeka) package insert
*Brief patient counseling information can be found on page 7 of the package insert
*Bendamustine (Bendeka) patient drug information (UpToDate)Bendamustine (Bendeka) patient drug information (UpToDate)
==History of changes in FDA indication==
As Treanda:
* 2008-03-20: Initial approval for the treatment of patients with chronic lymphocytic leukemia (CLL). (Based on Knauf et al. 2009)
*2008-10-31: Approved for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma (NHL) that progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen. (New disease entity; based on SDX-105-01 part 2)
As Bendeka:
*2015-12-07: Approved for chronic lymphocytic leukemia (CLL). (Based on Knauf et al. 2009)
*2015-12-07: Approved for indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. (Based on SDX-105-01 part 2)
==History of changes in EMA indication==
*2010-07-07: EURD
==History of changes in Health Canada indication==
*2012-08-24: Initial notice of compliance
==History of changes in PMDA indication==
*2010-10-27: Initial approval for the treatment of relapsed or refractory indolent B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma.
*2016-08-26: New additional indication and a new dosage for the treatment of chronic lymphocytic leukemia.
*2016-09-28: New additional indication, dosage, and dosage form for the treatment of chronic lymphocytic leukemia.
*2016-12-19: revised indication and a new dosage for the treatment of low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma.
*2019-03-26: indicated for the treatment prior to tumor-specific T-cell infusion therapy.
*2021-03-23: New indication and a new dosage for the treatment of relapsed or refractory diffuse large B-cell lymphoma.
==Also known as==
*Code names: CEP-18083, SDX-105, SyB L-0501
*Generic names: bendamustin hydrochloride, bendamustine hydrochloride, cytostasan hydrochloride
*Brand names: Belrapzo, Bendawel, Bendamax, Bendeka, Bendit, Bemustin, Bimode, Genmus, Innomustine, Kabimustine, Leuben, Levact, Maxtorin, MyMust, Neomustin, Nexben, Purplz, Ribomustin, Treakisym, Treanda, Vivimusta, Xyotin, Zumustin
==References==
Category:Drugs
Category:Intravenous medications
Category:Vesicant
Category:Nitrogen mustards
Category:Alkylating agents
Category:Chronic lymphocytic leukemia medications
Category:Classical Hodgkin lymphoma medications
Category:Cold agglutinin disease medications
Category:Cutaneous T-cell lymphoma medications
Category:Diffuse large B-cell lymphoma medications
Category:Follicular lymphoma medications
Category:Hairy cell leukemia medications
Category:Indolent lymphoma medications
Category:Light-chain (AL) amyloidosis medications
Category:MALT lymphoma medications
Category:Mantle cell lymphoma medications
Category:Multiple myeloma medications
Category:Peripheral T-cell lymphoma medications
Category:T-cell prolymphocytic leukemia medications
Category:Transformed lymphoma medications
Category:Small cell lung cancer medications
Category:FDA approved in 2008
Category:EMA approved in 2010
Category:Health Canada approved in 2012
Category:PMDA approved in 2010
Category:WHO Essential Cancer Medicine