Bendaz
Bendamustine Injection
Strength
✓100 mg
Pack Size
Vial
Drug Class
Alkylating agents
Specification
USP/BP/IH Specs offered for exports
Storage
Store at 25°C to 30°C.
Bendamustine is a nitrogen mustard drug indicated for use in the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Bendamustine is a bifunctional mechlorethamine derivative capable of forming electrophilic alkyl groups that covalently bond to other molecules.
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.
Bendamustine has demonstrated significant efficacy across multiple studies in various hematologic malignancies.
In patients with rituximab-refractory, indolent B-cell non-Hodgkin lymphoma (NHL), a Phase III study showed:
- Superior overall response rates (68% vs 39%)
- Longer median progression-free survival (21.7 vs 9.3 months)
- Prolonged remission duration (18.9 vs 6.1 months) compared to chlorambucil.
Another study in rituximab-refractory NHL reported
- Overall response rate of 84% with bendamustine monotherapy
- 29% complete response rate
- Median progression-free survival of 9.7 months.
Bendamustine has also shown efficacy in multiple myeloma (MM) and has approvals in Europe for MM, NHL, chronic lymphocytic leukemia (CLL), breast cancer, and Hodgkin lymphoma.
Primary dose-limiting toxicity was hematologic.
Pregnancy
The use of bendamustine should be avoided during pregnancy, particularly during the first trimester.
Breastfeeding
It is not recommended to breastfeed during treatment with bendamustine due to the potential for serious adverse reactions in nursing infants.
Fertility
Bendamustine may impair fertility in both men and women. Women of childbearing potential should use effective contraception during treatment with bendamustine.
Men should consider sperm preservation before starting bendamustine therapy, as it may lead to temporary or permanent infertility.
Teratogenicity
Pregnancy testing and effective contraception are recommended during and for at least six months after treatment with bendamustine to minimize the risk of fetal exposure.
Bendamustine hydrochloride is available in two formulations, a solution (Bendamustine Injection) and a lyophilized powder (Bendamustine for Injection).
For CLL
100 mg/m² infused intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles.
For NHL
120 mg/m² infused intravenously over 60 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles.