Bendamustine
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
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Overview
Bendamustine is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin Lymphoma (NHL). Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Chronic Lymphocytic Leukemia
- Dosing information
- Recommended Dosage:
- Recommended dosage:100 mg/m2 administered intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles.
- Dose Delays, Dose Modifications and Reinitiation of Therapy for CLL:
- TREANDA administration should be delayed in the event of Grade 4 hematologic toxicity or clinically significant ≥ Grade 2 non-hematologic toxicity. Once non-hematologic toxicity has recovered to ≤ Grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) ≥ 1 x 109/L, platelets ≥ 75 x 109/L], TREANDA can be reinitiated at the discretion of the treating physician. In addition, dose reduction may be warranted.
- Dose modifications for hematologic toxicity: for Grade 3 or greater toxicity, reduce the dose to 50 mg/m2 on Days 1 and 2 of each cycle; if Grade 3 or greater toxicity recurs, reduce the dose to 25 mg/m2 on Days 1 and 2 of each cycle.
- Dose modifications for non-hematologic toxicity: for clinically significant Grade 3 or greater toxicity, reduce the dose to 50 mg/m2 on Days 1 and 2 of each cycle.
- Dose re-escalation in subsequent cycles may be considered at the discretion of the treating physician.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Bendamustine in adult patients.
Non–Guideline-Supported Use
Metastatic breast cancer
- Dosing information
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Bendamustine FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Bendamustine in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Bendamustine in pediatric patients.
Contraindications
There is limited information regarding Bendamustine Contraindications in the drug label.
Warnings
There is limited information regarding Bendamustine Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Bendamustine Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Bendamustine Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Bendamustine Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Bendamustine in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bendamustine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Bendamustine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Bendamustine in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Bendamustine in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Bendamustine in geriatric settings.
Gender
There is no FDA guidance on the use of Bendamustine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Bendamustine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Bendamustine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Bendamustine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Bendamustine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Bendamustine in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Bendamustine Administration in the drug label.
Monitoring
There is limited information regarding Bendamustine Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Bendamustine and IV administrations.
Overdosage
There is limited information regarding Bendamustine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Bendamustine Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Bendamustine Mechanism of Action in the drug label.
Structure
There is limited information regarding Bendamustine Structure in the drug label.
Pharmacodynamics
There is limited information regarding Bendamustine Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Bendamustine Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Bendamustine Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Bendamustine Clinical Studies in the drug label.
How Supplied
There is limited information regarding Bendamustine How Supplied in the drug label.
Storage
There is limited information regarding Bendamustine Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Bendamustine Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Bendamustine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Bendamustine Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Bendamustine Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.