Bendamustine

Note: Previous Treanda formulation discontinued on 3/31/2016 by Teva to switch to Bendeka.

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

Diseases for which it is used

• Chronic lymphocytic leukemia (CLL/SLL)
• Cold agglutinin disease
• 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
• Small cell lung cancer
• Transformed lymphoma
• Waldenström macroglobulinemia

Patient drug information

• 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)

History of changes in FDA indication

As Treanda:

• 3/20/2008: Initial FDA approval for the treatment of patients with chronic lymphocytic leukemia (CLL).
• 10/31/2008: 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)

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

• Code names: CEP-18083, SDX-105, SyB L-0501
• Generic names: bendamustin hydrochloride, bendamustine hydrochloride, cytostasan hydrochloride
• Brand names: Bendamax, Bendawel, Bendeka, Bendit, Innomustine, Leuben, Levact, Maxtorin, MyMust, Purplz, Ribomustin, Treakisym, Treanda, Xyotin