Bendamustine Hydrochloride

What it is and how it works

Mechanism of Action Bendamustine is a bifunctional mechlorethamine derivative containing a purine-like benzimidazole ring. Mechlorethamine and its derivatives form electrophilic alkyl groups. These groups form covalent bonds with electron-rich nucleophilic moieties, resulting in interstrand DNA crosslinks. The bifunctional covalent linkage can lead to cell death via several pathways. Bendamustine is active against both quiescent and dividing cells. The exact mechanism of action of bendamustine remains unknown.

Indications

Bendamustine hydrochloride for Injection is an alkylating drug indicated for treatment of patients with: 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. Chronic Lymphocytic Leukemia (CLL) Bendamustine hydrochloride for Injection is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. Non-Hodgkin Lymphoma (NHL) Bendamustine hydrochloride for Injection is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Dosage and administration (summary)

Bendamustine hydrochloride is available in two formulations, a solution (Bendamustine Hydrochloride Injection) and a lyophilized powder (Bendamustine Hydrochloride for Injection). For CLL : 100 mg/m 2 infused intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles For NHL : 120 mg/m 2 infused intravenously over 60 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles Selection of Bendamustine Hydrochloride Formulation to Administer Bendamustine hydrochloride is available in two formulations, a solution (Bendamustine hydrochloride Injection) and a lyophilized powder (Bendamustine hydrochloride for Injection).

Contraindications

Bendamustine hydrochloride for Injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine. Bendamustine hydrochloride for Injection is contraindicated in patients with a history of a hypersensitivity reaction to bendamustine. Reactions have included anaphylaxis and anaphylactoid reactions. ( 4 , 5.4 )

Warnings and precautions

Myelosuppression: Delay or reduce dose and restart treatment based on ANC and platelet count recovery. Infections: Monitor for fever and other signs of infection or reactivation of infections and treat promptly. Progressive multifocal leukoencephalopathy (PML): Monitor for new or worsening neurological, cognitive or behavioral signs or symptoms suggestive of PML. Anaphylaxis and Infusion Reactions: Severe and anaphylactic reactions have occurred; monitor clinically and discontinue drug for severe reactions. Pre-medicate in subsequent cycles for milder reactions.

Pregnancy

Pregnancy Risk Summary In animal reproduction studies, intraperitoneal administration of bendamustine to pregnant mice and rats during organogenesis at doses 0.6 to 1.8 times the maximum recommended human dose (MRHD) resulted in embryo-fetal and/or infant mortality, structural abnormalities, and alterations to growth (see Data) .

Storage and supply

Safe Handling and Disposal Bendamustine hydrochloride is a hazardous drug. Follow applicable special handling and disposal procedures 1 . Care should be exercised in the handling and preparation of solutions prepared from Bendamustine hydrochloride for Injection, USP.

Source: Bendamustine Hydrochloride (Bendamustine Hydrochloride) — US FDA prescribing information, 2024-03-29, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.