Bendamustine
Bendamustine is an intravenous chemotherapy drug (an alkylating drug) used to treat chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has come back or worsened after rituximab.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 12 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Bendamustine is an IV chemotherapy drug (an alkylating drug, meaning it cross-links DNA inside cancer cells so the cells die) for chronic lymphocytic leukemia and for indolent B-cell non-Hodgkin lymphoma that has progressed after rituximab, an established option on the market since about 2008 and available generically. For a chemotherapy it is usually fairly well tolerated, and nausea, tiredness and sometimes a rash are what most people notice. The main risk is a serious drop in blood counts, which raises infection risk, so expect frequent blood tests and call your care team right away for fever, a rash or new confusion or memory changes.
Clinical pearls
- If allopurinol is prescribed to prevent tumor lysis syndrome, watch closely for skin reactions, since the combination raises that risk.
- Have any new medicine checked for effects on the liver enzyme CYP1A2, which can push bendamustine levels up or down.
- Report redness, swelling or pain at the IV site during or after the infusion, since leaked drug can injure tissue.
- Women need effective contraception for 6 months after the last dose, and men with female partners for 3 months.
Patient information guide A plain-language walkthrough of Bendamustine, written from its FDA label.
What Bendamustine is used for
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Bendamustine is used in adults for these blood cancers:
- Chronic lymphocytic leukemia (CLL), for the products labeled for it, including Treanda, Belrapzo, Bendeka and Vivimusta.
- Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of rituximab or a rituximab-containing regimen.
- One bendamustine hydrochloride injection solution product is labeled only for the NHL use.
How Bendamustine works
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Bendamustine is an alkylating drug. It attaches to DNA in cells and links the DNA strands together. This damage can lead to cancer cell death.
It acts on both resting and actively dividing cells. Its exact mechanism is not fully known.
Bendamustine dosage
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Bendamustine is given by IV infusion by a healthcare professional, on Days 1 and 2 of each cycle. Cycle length and number of cycles differ for CLL and NHL.
- Infusion time varies by product (for example, about 10 minutes for Bendeka and about 20 minutes for Vivimusta).
- Solution and powder formulations have different concentrations and should not be mixed.
- Treatment may be delayed or reduced based on blood counts and side effects.
Your care team schedules your doses, so follow their directions.
Dosing details from the FDA-approved label
From the Bendamustine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- CLL
- 100 mg/m2 administered intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles
- NHL
- 120 mg/m2 administered intravenously over 60 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION TREANDA is available in two formulations, a solution (TREANDA Injection) and a lyophilized powder (TREANDA for Injection). ( 2.1 ) Do not use TREANDA injection with devices that contain polycarbonate or acrylonitrile-butadiene-styrene (ABS), including most Closed System Transfer Devices (CSTDs). ( 2.1 , 2.4 ) 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 ( 2.2 ) 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 ( 2.3 ) 2.1 Selection of TREANDA Formulation to Administer TREANDA is available in two formulations, a solution (TREANDA Injection) and a lyophilized powder (TREANDA for Injection). Do not use TREANDA Injection if you intend to use closed system transfer devices (CSTDs), adapters and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS) prior to dilution in the infusion bag [see Dosage and Administration ( 2.4 )] . If using a syringe to withdraw and transfer TREANDA Injection from the vial into the infusion bag, only use a polypropylene syringe with a metal needle and polypropylene hub to withdraw and transfer TREANDA Injection into the infusion bag. Polypropylene syringes are translucent in appearance. TREANDA Injection and the reconstituted TREANDA for Injection have different concentrations of bendamustine hydrochloride. The concentration of bendamustine hydrochloride in the solution is 90 mg/mL and the concentration of bendamustine hydrochloride in the reconstituted solution of lyophilized powder is 5 mg/mL. Do not mix or combine the two formulations. TREANDA Injection must be withdrawn and transferred for dilution in a biosafety cabinet (BSC) or containment isolator using a polypropylene syringe with a metal needle and a polypropylene hub. If a CSTD or adapter that contains polycarbonate or ABS is used as supplemental protection prior to dilution 1 , only use TREANDA for Injection, the lyophilized powder formulation [see How Supplied/Storage and Handling ( 16 )] . 2.2 Dosing Instructions for CLL Recommended Dosage: The recommended dose is 100 mg/m 2 administered intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Bendamustine side effects
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Common side effects include:
Common side effects
- Nausea
- Vomiting
- Fatigue
- Fever (pyrexia)
- Low blood counts (anemia, low platelets, low white cells)
- Diarrhea or constipation
- Rash
- Headache
- Fatigue and weakness
- Low red cells, white cells and platelets
- Rash, headache, cough, mouth sores
When to get medical help
- Fever, chills or other signs of infection, since low blood counts make infections more likely
- Rash, itching, fever or chills during or after an infusion, or any signs of a severe allergic reaction
- Severe or worsening skin reactions, blisters or peeling skin
- New or worsening confusion, memory, behavior or nervous system symptoms (possible PML, a rare brain infection)
- Redness, swelling or pain at the IV site
- Signs of liver problems
- Signs of tumor lysis syndrome, which can lead to kidney failure
Call your care team promptly for signs of infection, allergic reactions, severe skin reactions or neurological changes.
Bendamustine warnings and precautions
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- Myelosuppression: severe drops in blood counts, with blood tests done often.
- Infections: including reactivation of hepatitis B, CMV, tuberculosis and shingles.
- PML: a rare brain infection, seen mostly with rituximab or obinutuzumab.
- Infusion and allergic reactions: severe reactions are rare but can occur, especially in later cycles.
- Tumor lysis syndrome: can lead to kidney failure.
- Skin reactions: including SJS, TEN and DRESS, some fatal.
- Liver injury: liver tests are checked before and during treatment.
- Other cancers and extravasation (leakage at the IV site).
- Fetal harm.
Bendamustine interactions
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The main interactions involve the liver enzyme CYP1A2.
- CYP1A2 inhibitors may raise bendamustine levels and side effects.
- CYP1A2 inducers may lower levels and reduce effectiveness.
- Allopurinol may raise the risk of severe skin reactions.
Interactions listed in the FDA-approved label
From the Bendamustine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- CYP1A2 inhibitors: Coadministration may increase bendamustine plasma concentrations and may result in increased incidence of adverse reactions. Consider alternative therapies that are not CYP1A2 inhibitors during treatment with Bendamustine Hydrochloride Injection.
- CYP1A2 inducers: Coadministration may decrease bendamustine plasma concentrations and may result in decreased efficacy. Consider alternative therapies that are not CYP1A2 inducers during treatment with Bendamustine Hydrochloride Injection.
Read the label’s full interactions text
7 DRUG INTERACTIONS Consider alternative therapies that are not CYP1A2 inducers or inhibitors during treatment with Bendamustine Hydrochloride Injection. ( 7.1 ) 7.1 Effect of Other Drugs on Bendamustine Hydrochloride Injection CYP1A2 Inhibitors The coadministration of Bendamustine Hydrochloride Injection with CYP1A2 inhibitors may increase bendamustine plasma concentrations and may result in increased incidence of adverse reactions with Bendamustine Hydrochloride Injection [see Clinical Pharmacology ( 12.3 )] . Consider alternative therapies that are not CYP1A2 inhibitors during treatment with Bendamustine Hydrochloride Injection. CYP1A2 Inducers The coadministration of Bendamustine Hydrochloride Injection with CYP1A2 inducers may decrease bendamustine plasma concentrations and may result in decreased efficacy of Bendamustine Hydrochloride Injection [see Clinical Pharmacology ( 12.3 )] . Consider alternative therapies that are not CYP1A2 inducers during treatment with Bendamustine Hydrochloride Injection.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Bendamustine
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- Do not use if you are allergic to bendamustine or its listed ingredients.
- Pregnancy: can cause fetal harm; pregnancy testing and contraception are advised.
- Breastfeeding: not recommended during treatment and for 1 week after.
- Fertility: may impair male fertility.
- Kidney: do not use if creatinine clearance is under 30 mL/min.
- Liver: do not use with certain levels of liver impairment.
- Children: safety and effectiveness not established.
- Older adults: CLL response was lower in those 65 and over.
Bendamustine overdose
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Overdose effects seen at high doses included heart rhythm changes on ECG such as QT prolongation and fast heart rate. There is no known antidote. Care focuses on supportive measures and monitoring blood counts and ECGs.
What Bendamustine does in the body
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Nausea increased as bendamustine peak levels rose. In a study of 53 patients, no average QTc change greater than 20 milliseconds was found up to one hour after infusion. Delayed effects on the QT interval were not evaluated.
How your body processes Bendamustine
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Bendamustine peaks at the end of the infusion. The parent drug has a half-life of about 40 minutes. It is extensively broken down in the body, mostly by hydrolysis, and two minor active metabolites are formed by CYP1A2. About half of a dose is recovered in urine and about a quarter in feces. Little accumulation is expected with dosing on Days 1 and 2 of a 28-day cycle.
How to store Bendamustine
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Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Bendamustine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Bendamustine — the kind of thing our pharmacy team would talk through with you at the counter.
What is bendamustine for?
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How will I get it?
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What side effects should I expect?
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When should I call my care team?
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Can I take other medicines with it?
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Is it safe in pregnancy?
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Is Bendamustine available over the counter?
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When was Bendamustine first available?
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Who makes Bendamustine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Bendamustine on HelloPharmacist
Bendamustine forms and strengths (how it comes)
Bendamustine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Treanda, Belrapzo, Bendeka and Vivimusta are each labeled for CLL and for indolent B-cell NHL that progressed after rituximab.
- One bendamustine hydrochloride injection solution product is labeled only for indolent B-cell NHL after rituximab.
- Bendeka is infused over about 10 minutes.
- Vivimusta is infused over about 20 minutes.
- Belrapzo is infused over about 30 minutes for CLL and 60 minutes for NHL.
- Treanda is available as a solution and a powder; Treanda injection should not be used with devices containing polycarbonate or ABS, including most closed system transfer devices.
Bendamustine on the U.S. market: products, makers and brands
How Bendamustine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
12 companies list 16 Bendamustine product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2008. Brand names on the directory include Bendeka, Treanda, Belrapzo and 1 more; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (13) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Bendamustine is used (Medicaid data)
A general measure of how commonly Bendamustine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Bendamustine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Bendamustine prescribed? Of the 1,601 medications we measure, Bendamustine ranks #1,191 by Medicaid prescriptions — more than 26% of them.
Utilization by Bendamustine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
bendamustine hydrochloride 25 MG/ML Injectable Solution Most dispensed
Summed across the 4 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1726097
bendamustine hydrochloride 100 MG Injection
Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1805001
bendamustine hydrochloride 25 MG Injection
Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1805007
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Bendamustine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 8 of 19 listed Bendamustine NDCs with Medicaid activity.
Compare Bendamustine products
A representative set of FDA-listed product records for Bendamustine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 25 mg/5 mL | Intravenous | Accord Healthcare, Inc. | ANDA | View NDC → |
| 100 mg/20 mL | Intravenous | Accord Healthcare, Inc. | ANDA | View NDC → |
| 25 mg/mL | Intravenous | Apotex Corp | NDA | View NDC → |
| 100 mg/4 mL | Intravenous | Avyxa Pharma, LLC | NDA | View NDC → |
| 25 mg/mL | Intravenous | Azurity Pharmaceuticals, Inc. | NDA | View NDC → |
| 100 mg | Intravenous | Baxter Healthcare Corporation | NDA | View NDC → |
| 100 mg/20 mL | Intravenous | BluePoint Laboratories | ANDA | View NDC → |
| 25 mg/5 mL | Intravenous | Cephalon, LLC | NDA | View NDC → |
| 100 mg/20 mL | Intravenous | Cephalon, LLC | NDA | View NDC → |
| 100 mg/4 mL | Intravenous | Eagle Pharmaceuticals, Inc | NDA | View NDC → |
| 25 mg/5 mL | Intravenous | Eugia US LLC | ANDA | View NDC → |
| 100 mg/20 mL | Intravenous | Eugia US LLC | ANDA | View NDC → |
| 25 mg/5 mL | Intravenous | Meitheal Pharmaceuticals Inc. | ANDA | View NDC → |
| 100 mg/20 mL | Intravenous | Meitheal Pharmaceuticals Inc. | ANDA | View NDC → |
| 25 mg/mL | Intravenous | Slayback Pharma LLC | NDA | View NDC → |
| 25 mg/mL | Intravenous | Teva Pharmaceuticals USA, Inc. | NDA | View NDC → |
Showing 16 of 16 products — FDA National Drug Code Directory. See every product, package size and price: browse all 16 Bendamustine NDCs →
Bendamustine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Bendamustine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Bendamustine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Bendamustine FDA approval history
How Bendamustine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Bendamustine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Bendamustine recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01. Lots: Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025 FDA record D-1103-2023 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 134547 2 dose forms · 3 strengths
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Dose form (SCDF) Injectable Solution RxCUI 790322In current FDA listingsClinical drug / strength (SCD) hydrochloride 25 MG/MLRxCUI 1726097 -
Dose form (SCDF) Injection RxCUI 1805000In current FDA listings
Look up RxCUI 134547 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Bendamustine supply and shortage status
Whether Bendamustine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Bendamustine brand names
Bendamustine is sold under 4 brand names in the FDA directory — Bendeka, Treanda, Belrapzo, Vivimusta. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Bendamustine: manufacturers and labelers
12 companies list Bendamustine products with the FDA. By number of product records, the largest are Accord Healthcare, Inc., Cephalon, LLC, Eugia US LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Bendamustine drug class (RxNorm)
Bendamustine belongs to the Alkylating Drug class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Bendamustine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Meitheal Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →