Molecule
Bendamustine is an alkylating drug indicated for treatment of patients with chronic lymphocytic leukemia (CLL), among other approved uses. It is available as powder for injection and injection for intravenous use. MedsAcross supplies Bendamustine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
TREANDA 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.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
TREANDA is available in two formulations, a solution (TREANDA Injection) and a lyophilized powder (TREANDA for Injection). Do not use TREANDA injection with devices that contain polycarbonate or acrylonitrile-butadiene-styrene (ABS), including most Closed System Transfer Devices (CSTDs). 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
Source: US FDA prescribing information
TREANDA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine. TREANDA is contraindicated in patients with a history of a hypersensitivity reaction to bendamustine. Reactions have included anaphylaxis and anaphylactoid reactions.
Source: US FDA prescribing information
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. Tumor Lysis Syndrome: May lead to acute renal failure and death, anticipate and use supportive measures in patients at high risk. Skin Reactions: Discontinue for severe skin reactions. Cases of SJS, DRESS and TEN, some fatal, have been reported. Hepatotoxicity: Monitor liver chemistry tests prior to and during treatment.
Source: US FDA prescribing information
The following clinically significant adverse reactions have been associated with TREANDA in clinical trials and are discussed in greater detail in other sections of the label. Myelosuppression Infections Progressive Multifocal Leukoencephalopathy Anaphylaxis and Infusion Reactions Tumor Lysis Syndrome Skin Reactions Hepatotoxicity Other Malignancies Extravasation Injury Adverse reactions (frequency >5%) during infusion and within 24 hours post-infusion are nausea and fatigue. Most common adverse reactions (≥15%) for CLL are anemia, thrombocytopenia, neutropenia, lymphopenia, leukopenia, pyrexia, nausea, vomiting. Most common adverse reactions (≥15%) for NHL are lymphopenia, leukopenia, anemia, neutropenia, thrombocytopenia, nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis.
Source: US FDA prescribing information
Consider alternative therapies that are not CYP1A2 inducers or inhibitors during treatment with TREANDA. Effect of Other Drugs on TREANDA CYP1A2 Inhibitors The coadministration of TREANDA with CYP1A2 inhibitors may increase bendamustine plasma concentrations and may result in increased incidence of adverse reactions with TREANDA. Consider alternative therapies that are not CYP1A2 inhibitors during treatment with TREANDA. CYP1A2 Inducers The coadministration of TREANDA with CYP1A2 inducers may decrease bendamustine plasma concentrations and may result in decreased efficacy of TREANDA. Consider alternative therapies that are not CYP1A2 inducers during treatment with TREANDA.
Source: US FDA prescribing information
Storage TREANDA Injection (45 mg/0.5 mL or 180 mg/2 mL solution) Store TREANDA Injection in refrigerator 2°C to 8°C (36°F to 46°F). TREANDA for Injection (25 mg/vial or 100 mg/vial lyophilized powder) TREANDA for Injection may be stored up to 25°C (77°F) with excursions permitted up to 30°C (86°F). Retain in original package until time of use to protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
9 presentations of Bendamustine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Bendamustine 100 mg/20 mL powder for injectionIntravenousGeneric name | — | US FDA | Available on request |
| Vivimusta 100 mg/4 mL injectionIntravenous Cold chain | Azurity Pharmaceuticals | US FDA | Available on request |
| Treanda 100 mg/20 mL powder for injectionIntravenous Cold chain | Cephalon | US FDA | Available on request |
| Belrapzo 100 mg/4 mL injectionIntravenous Cold chain | Eagle Pharmaceuticals | US FDA | Available on request |
| Bendamustine 100 mg injectionIntravenous Cold chainGeneric name | — | US FDA | Available on request |
| Bendamustine 100 mg/4 mL injectionIntravenous Cold chainGeneric name | — | US FDA | Available on request |
| Bendamustine 125 mg/5 mL injectionIntravenous Cold chainGeneric name | — | US FDA | Available on request |
| Bendeka 100 mg/4 mL injectionIntravenous Cold chain | Teva Pharmaceuticals | US FDA | Available on request |
| Gobarden 100 mg/4 mL injectionIntravenous Cold chain | Avyxa Pharma | US FDA | Available on request |
5 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 20 March 2008 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Bendamustine in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 9 presentations of Bendamustine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 5 brand names for Bendamustine, including Belrapzo, Bendeka, Gobarden, Treanda, Vivimusta.
Yes. The US FDA first approved Bendamustine on 20 March 2008, according to Drugs@FDA.
At least one listed presentation of Bendamustine must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Bendamustine is classified under ATC code L01AA09 (Bendamustine).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.