Bendamustine
Nitrogen Mustard Analogues
- Drug class
- Nitrogen Mustard Analogues
- Availability
- Prescription only
- Routes
- Intravenous
- Markets covered
- 3
- Products on record
- 18
Overview
Bendamustine is an active pharmaceutical ingredient in the Nitrogen Mustard Analogues group (L01AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 8 | May 15, 2026 |
| CA Canada | Health Canada | 8 | September 15, 2025 |
| US United States | FDA | 2 | September 16, 2025 |
GBUnited Kingdom· MHRA
8 products
Uses
First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate. Indolent non-Hodgkin’s lymphomas as monotherapy in patients who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen.
Front line treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment.
How to take
CACanada· Health Canada
8 products
Uses
Bendamustine Hydrochloride for Injection is indicated for treatment of patients with: • Relapsed indolent B-cell non-Hodgkin lymphoma (NHL) who did not respond to or progressed during or shortly following treatment with a rituximab regimen.
Effectiveness of bendamustine hydrochloride in patients with indolent B-cell NHL is based on overall response rate and duration of response data from a single -arm pivotal study of bendamustine hydrochloride monotherapy in patients who had prior chemotherapy and did not respond to or progressed during or within 6 months of treatment with rituximab or a rituximab-based regimen (see 14 CLINICAL TRIALS).
• Symptomatic chronic lymphocytic leukemia (CLL) who have received no prior treatment. Approval of bendamustine hydrochloride in CLL is based on a progression-free survival and overall response rate advantage of bendamustine hydrochloride over chlorambucil in a single randomized controlled trial.
USUnited States· FDA
2 products
Uses
1 INDICATIONS AND USAGE Non-Hodgkin Lymphoma (NHL) Bendamustine hydrochloride injection is indicated for the treatment of adult 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.
Bendamustine hydrochloride injection is an alkylating drug indicated for treatment of adult patients with: • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
( 1 )
How to take
Drug interactions
Known interactions involving Bendamustine. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL085530571 · revised September 1, 2025
- [2]Health Canada (DPD) · 02496852 · revised March 22, 2025
- [3]FDA DailyMed · 085dd54c-4212-d8… · revised September 16, 2025 [PDF]
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.