Generic Name
Bendamustine
Brand Names
Vivimusta, Bendeka, Treanda, Belrapzo
FDA approval date: March 31, 2008
Classification: Alkylating Drug
Form: Injection
What is Vivimusta (Bendamustine)?
Bendamustine Hydrochloride for Injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia . Efficacy relative to first line therapies other than chlorambucil has not been established.
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Brand Information
VIVIMUSTA (BENDAMUSTINE HYDROCHLORIDE)
1DOSAGE FORMS & STRENGTHS
Injection: 100 mg/4 mL (25 mg/mL) as a clear and colorless to yellow solution in multiple-dose vial.
2CONTRAINDICATIONS
VIVIMUSTA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, dehydrated alcohol, or monothioglycerol
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labelling:
• Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (
• Anaphylaxis and Infusion-Related Reactions [see Warnings and Precautions (
• Tumor Lysis Syndrome [see Warnings and Precautions (
• Skin Reactions [see Warnings and Precautions (
• Hepatotoxicity [see Warnings and Precautions (
• Other Malignancies [see Warnings and Precautions (
• Extravasation Injury [see Warnings and Precautions (
• Tumor Lysis Syndrome [see Warnings and Precautions (
• Skin Reactions [see Warnings and Precautions (
• Hepatotoxicity [see Warnings and Precautions (
• Other Malignancies [see Warnings and Precautions (
• Extravasation Injury [see Warnings and Precautions (
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to bendamustine hydrochloride in 153 patients. Bendamustine hydrochloride was studied in an active-controlled, randomized trial. The population was 45-77 years of age, 63% were male, 100% were White, and had treatment naïve CLL. All patients started the study at a dose of 100 mg/m2 intravenously over 30 minutes on Days 1 and 2 every 28 days.
Worsening hypertension was reported in 4 patients treated with bendamustine hydrochloride and in none treated with chlorambucil. Three of these 4 adverse reactions were described as a hypertensive crisis and were managed with oral medications and resolved.
The most frequent adverse reactions leading to study withdrawal for patients receiving bendamustine hydrochloride were hypersensitivity (2%) and pyrexia (1%).
Table 2 summarizes the adverse reactions that were reported in ≥ 5% of patients in either treatment group in the randomized CLL clinical study.
Table 2: Non-Hematologic Adverse Reactions that Occurred in at Least 5% of Patients Who Received Bendamustine Hydrochloride or Chlorambucil in the Randomized CLL Clinical Study
Hematology laboratory abnormalities are described in Table 3. Red blood cell transfusions were administered to 20% of patients receiving bendamustine hydrochloride compared with 6% of patients receiving chlorambucil. Bilirubin elevation occurred in 34% of patients, some without associated significant elevations in AST and ALT. Grade 3 or 4 increased bilirubin occurred in 3% of patients. Increases in AST and ALT of Grade 3 or 4 were limited to 1% and 3% of patients, respectively. Patients treated with bendamustine hydrochloride may also have changes in their creatinine levels.
Non-Hodgkin Lymphoma (NHL)
The data described below reflect exposure to bendamustine hydrochloride in 176 patients with indolent B-cell NHL treated in two single-arm studies. The population was 31-84 years of age; 60% were male; 89% were White, 7% were Black, 3% were Hispanic, 1% were other, and <1% were Asian. These patients received bendamustine hydrochloride at a dose of 120 mg/m
The most common non-hematologic adverse reactions (≥30%) were nausea (75%), fatigue (57%), vomiting (40%), diarrhea (37%) and pyrexia (34%). The most common non-hematologic Grade 3 or 4 adverse reactions (≥5%) were fatigue (11%), febrile neutropenia (6%), and pneumonia, hypokalemia and dehydration, each reported in 5% of patients.
Table 4: Non-Hematologic Adverse Reactions that Occurred in at Least 5% of Patients who Received Bendamustine Hydrochloride in the NHL Studies
*Patients may have reported more than 1 adverse reaction.
NOTE: Patients counted only once in each preferred term category and once in each body system category.
Hematologic toxicities, based on laboratory values and CTC grade, in patients with NHL treated in both single arm studies combined are described in Table 5. Clinically important chemistry laboratory values that were new or worsened from baseline and occurred in >1% of patients at grade 3 or 4, in patients with NHL who were treated in both single arm studies combined were hyperglycemia (3%), elevated creatinine (2%), hyponatremia (2%), and hypocalcemia (2%).
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of bendamustine hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic systems disorders: Pancytopenia.
Cardiovascular disorders: Atrial fibrillation, congestive heart failure (some fatal), myocardial infarction (some fatal), palpitation.
General disorders and administration site conditions: Injection site reactions (including phlebitis, pruritus, irritation, pain, swelling), infusion site reactions (including phlebitis, pruritus, irritation, pain, swelling).
Immune system disorders: Anaphylaxis.
Infections and infestations: Pneumocystis jiroveci pneumonia, progressive multifocal leukoencephalopathy (PML).
Renal and urinary disorders: Nephrogenic diabetes insipidus (NDI)
Respiratory, thoracic and mediastinal disorders: Pneumonitis.
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and non-melanoma skin cancer (NMSC).
4OVERDOSAGE
The intravenous lethal dose 50 (LD
5DESCRIPTION
Bendamustine hydrochloride is an alkylating agent. The chemical name of bendamustine hydrochloride monohydrate is 5-[Bis(2-chloroethyl)-amino]-1-methyl-1H-benzimidazole-2- butanoic acid hydrochloride monohydrate. Its empirical molecular formula is C
VIVIMUSTA (bendamustine hydrochloride injection) is intended for intravenous use after dilution with either 0.9% Sodium Chloride Injection, USP or 2.5% Dextrose/0.45% Sodium Chloride Injection, USP. It is supplied as a sterile, clear, and colorless to yellow solution in a clear glass multiple-dose vial. Each milliliter contains 25 mg of bendamustine hydrochloride equivalent to 22.7 mg of bendamustine, 5 mg of monothioglycerol, 39.45 mg (5% v/v) of absolute alcohol, and q.s. to 1 mL polyethylene glycol 400. Sodium hydroxide is used to adjust pH of polyethylene glycol 400.
6REFERENCES
1. OSHA Hazardous Drugs.
7HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
VIVIMUSTA (bendamustine hydrochloride injection) is a sterile clear, colorless to yellow solution for intravenous use supplied in individual cartons of multiple-dose vials providing 100 mg bendamustine hydrochloride per 4 mL.
VIVIMUSTA (bendamustine hydrochloride injection) is a sterile clear, colorless to yellow solution for intravenous use supplied in individual cartons of multiple-dose vials providing 100 mg bendamustine hydrochloride per 4 mL.
100 mg/4 mL (25 mg/mL) NDC 24338-270-01
VIVIMUSTA (bendamustine hydrochloride injection) is a hazardous drug. Follow applicable special handling and disposal procedures
Store VIVIMUSTA (bendamustine hydrochloride injection) refrigerated at 2°C to 8°C (36°F to 46°F). Retain in original carton until time of use to protect from light.
8PATIENT COUNSELING INFORMATION
Myelosuppression
Inform patients of the likelihood that bendamustine hydrochloride will cause a decrease in white blood cells, platelets, and red blood cells and the need for frequent monitoring of blood counts. Advise patients to report shortness of breath, significant fatigue, bleeding, fever, or other signs of infection [see Warnings and Precautions (
Inform patients of the likelihood that bendamustine hydrochloride will cause a decrease in white blood cells, platelets, and red blood cells and the need for frequent monitoring of blood counts. Advise patients to report shortness of breath, significant fatigue, bleeding, fever, or other signs of infection [see Warnings and Precautions (
Progressive Multifocal Leukoencephalopathy (PML)
Inform patients to immediately contact their healthcare provider if they experience confusion, memory loss, trouble thinking, difficulty talking or walking, vision loss or other neurological or cognitive symptoms [see Warnings and Precautions (].
Anaphylaxis and Infusion-Related Reactions
Inform patients of the possibility of serious or mild allergic reactions and to immediately report rash, facial swelling, or difficulty breathing during or soon after infusion [see Warnings and Precautions (
Skin Reactions
Advise patients that a rash or itching may occur during treatment with VIVIMUSTA. Advise patients to immediately report severe or worsening rash or itching [see Warnings and Precautions (.
Hepatotoxicity
Inform patients of the possibility of developing liver function abnormalities and serious hepatic toxicity. Advise patients to immediately contact their healthcare provider if signs of liver failure occur, including jaundice, anorexia, bleeding or bruising [see Warnings and Precautions (.
Fatigue
Advise patients that VIVIMUSTA may cause tiredness and to avoid driving any vehicle or operating any dangerous tools or machinery if they experience this side effect [see Adverse Reactions (
Nausea and Vomiting
Advise patients that VIVIMUSTA may cause nausea and/or vomiting. Patients should report nausea and vomiting so that symptomatic treatment may be provided [see Adverse Reactions (
Diarrhea
Advise patients that VIVIMUSTA may cause diarrhea. Patients should report diarrhea to the healthcare provider so that symptomatic treatment may be provided [see Adverse Reactions (
Inform patients of the possibility of serious or mild allergic reactions and to immediately report rash, facial swelling, or difficulty breathing during or soon after infusion [see Warnings and Precautions (
Skin Reactions
Advise patients that a rash or itching may occur during treatment with VIVIMUSTA. Advise patients to immediately report severe or worsening rash or itching [see Warnings and Precautions (.
Hepatotoxicity
Inform patients of the possibility of developing liver function abnormalities and serious hepatic toxicity. Advise patients to immediately contact their healthcare provider if signs of liver failure occur, including jaundice, anorexia, bleeding or bruising [see Warnings and Precautions (.
Fatigue
Advise patients that VIVIMUSTA may cause tiredness and to avoid driving any vehicle or operating any dangerous tools or machinery if they experience this side effect [see Adverse Reactions (
Nausea and Vomiting
Advise patients that VIVIMUSTA may cause nausea and/or vomiting. Patients should report nausea and vomiting so that symptomatic treatment may be provided [see Adverse Reactions (
Diarrhea
Advise patients that VIVIMUSTA may cause diarrhea. Patients should report diarrhea to the healthcare provider so that symptomatic treatment may be provided [see Adverse Reactions (
Non-melanoma Skin Cancer (NMSC)
Advise patients to undergo regular skin cancer screenings, and to report any suspicious skin changes to their healthcare provider [see Warnings and Precautions (.
Embryo-Fetal Toxicity
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (Specific Populations (
Advise female patients of reproductive potential to use effective contraception during treatment with VIVIMUSTA and for 6 months after the last dose [see Use in Specific Populations (
Advise males with female partners of reproductive potential to use effective contraception during treatment with VIVIMUSTA and for 3 months after the last dose [see Use in Specific Populations (8.3) and Nonclinical Toxicology (
Lactation
Advise females not to breastfeed during treatment with VIVIMUSTA and for 1 week after the last dose [see Use in Specific Populations (
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (Specific Populations (
Advise female patients of reproductive potential to use effective contraception during treatment with VIVIMUSTA and for 6 months after the last dose [see Use in Specific Populations (
Advise males with female partners of reproductive potential to use effective contraception during treatment with VIVIMUSTA and for 3 months after the last dose [see Use in Specific Populations (8.3) and Nonclinical Toxicology (
Lactation
Advise females not to breastfeed during treatment with VIVIMUSTA and for 1 week after the last dose [see Use in Specific Populations (
Infertility
Advise males of reproductive potential that VIVIMUSTA may impair fertility [see Use in Specific Populations (
Advise males of reproductive potential that VIVIMUSTA may impair fertility [see Use in Specific Populations (
Manufactured for:
Vivimusta
Rev. MAR2025
9PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel - Carton Label
NDC 24338-270-01
VIVIMUSTA® (bendamustine hydrochloride injection)
NDC 24338-270-01
VIVIMUSTA® (bendamustine hydrochloride injection)
100 mg/4mL (25 mg/mL)
Principal Display Panel - Vial Label
VIVIMUSTA
100 mg/4mL (25 mg/mL)
