Generic
Bendamustine
1 brands available in the market
At a glance
Bendamustine is an antineoplastic alkylating agent used in the treatment of chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), and multiple myeloma. It creates crosslinks in DNA and RNA of cancer cells, stopping their growth and multiplication.
Description
Bendamustine is a bifunctional mechlorethamine derivative capable of forming electrophilic alkyl groups that covalently bond to other molecules. Through this function as an alkylating agent, bendamustine causes intra- and inter-strand crosslinks between DNA bases resulting in cell death. It is active against both active and quiescent cells.
Bendamustine is indicated for chronic lymphocytic leukemia, indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of rituximab-containing therapy, and multiple myeloma.
The medicine is administered as an IV infusion under the supervision of a doctor.
Indications
- Chronic Lymphocytic Leukemia (CLL)
- Non-Hodgkin Lymphoma (NHL) - Indolent B-cell NHL progressed during or within 6 months of rituximab-containing therapy
- Multiple myeloma
Therapeutic class
Cytotoxic Chemotherapy
Pharmacological class
Alkylating Agent (Nitrogen Mustard Derivative)
Pharmacology
Bendamustine is a bifunctional mechlorethamine derivative capable of forming electrophilic alkyl groups that covalently bond to other molecules. As an alkylating agent, it causes intra- and inter-strand crosslinks between DNA bases, disrupting DNA replication and RNA transcription, leading to disruption of nucleic acid function. It is active against both active and quiescent cells.
Mechanism of action
Bendamustine attaches alkyl groups to DNA, creating crosslinks between DNA strands. This disrupts DNA replication and RNA transcription, impairing nucleic acid function and ultimately leading to cell death.
Dosage
Chronic Lymphocytic Leukemia (CLL): 100 mg/m² IV infusion (30-60 min) on Days 1 and 2 of a 28-day cycle, up to 6 cycles.
Severe toxicity: Reduce to 50 mg/m² on Days 1 and 2; if recurs, reduce to 25 mg/m².
Multiple Myeloma: 120-150 mg/m² IV infusion (30-60 min) on Days 1 and 2 of a 28-day cycle. Prednisone 60 mg/m² may be given on Days 1-4.
Non-Hodgkin Lymphoma (NHL): 120 mg/m² IV infusion (30-60 min) on Days 1 and 2 of a 21-day cycle, up to 8 cycles.
Severe toxicity: Reduce to 90 mg/m² on Days 1 and 2; if recurs, reduce to 60 mg/m².
Hepatic impairment: Mild: Caution; Moderate: Reduce dose by 30%; Severe: Not recommended.
Renal impairment (CrCl <40 mL/min): Not recommended.
Administration
For IV infusion only. Administered by doctor or nurse as a 30-60 minute infusion. Patient should not self-administer. Reconstitute powder with sterile water, then dilute in 500 mL of 0.9% NaCl or 2.5% Dextrose + 0.45% NaCl to a final concentration of 0.2-0.6 mg/mL.
Missed dose
Hospital-only medicine. Administered by doctor or nurse. Patient should not self-administer. If you miss a dose, consult your doctor. Do not double the dose.
Side effects
Common side effects:
Anemia (low red blood cells), leukopenia (low white blood cells), neutropenia, thrombocytopenia (low platelets), lymphopenia, infection, fatigue, nausea, vomiting, fever, diarrhea, constipation, anorexia, weight decrease, rash, stomatitis (mouth inflammation), cough, headache.
Serious: Malignant and pre-malignant disease, severe hematological toxicity, cardiotoxicity.
Precautions & warnings
- Caution in mild-to-moderate hepatic and renal impairment.
- Do not use during pregnancy and lactation (Category D).
- Increased risk of infection; monitor CBC, kidney, liver, and cardiac function regularly.
- Use effective contraception during and after treatment.
- Avoid driving or activities requiring concentration until you know how it affects you.
Contraindications
- History of hypersensitivity to bendamustine (e.g., anaphylaxis and anaphylactoid reactions)
- Jaundice
- Severe bone marrow suppression
- Low leukocyte or platelet count
- Severe hepatic impairment
- Major surgery <30 days prior to treatment
Drug interactions
- CYP1A2 inhibitors (ciprofloxacin, fluvoxamine): May increase bendamustine plasma levels.
- CYP1A2 inducers (omeprazole and tobacco smoking): May reduce bendamustine plasma levels.
Food interactions
It is not known whether it is safe to consume alcohol with Bendamustine. Please consult your doctor.
Use in pregnancy
Unsafe during pregnancy (Category D). Positive evidence of human fetal risk. May be used in life-threatening situations if benefits outweigh risks.
Pregnancy Category: D — always consult a doctor before taking during pregnancy.
Use in lactation
Unsafe during breastfeeding. Data suggests the drug may cause toxicity to the baby.
Pediatric use
Safety and effectiveness in pediatric patients have not been established.
Geriatric use
No specific dose adjustment required for elderly, but dose should be based on patient condition.
Renal / hepatic impairment
Hepatic impairment: Mild: Caution; Moderate: Reduce dose by 30%; Severe: Not recommended.
Overdose effects
Symptoms: Cardiotoxicity, thrombocytopenia. Management: Bone marrow transplantation and transfusions may be performed. Dialyzable to a small extent.
Storage conditions
Store below 25°C prior to reconstitution. Protect from light.
Chemical structure
Bendamustine Hydrochloride (Alkylating Agent)