Adult Dosing
Chronic Lymphocytic leukemia (CLL)
- 100 mg/m2 IV (over 30 mins) on day 1 and 2 of a 28-day cycle, up to 6 cycles
- Dose modifications for hematological toxicity: For Grade 3 or greater toxicity, reduce dose to 50 mg/m2 on Days 1 and 2; if Grade 3 or greater toxicity recurs, reduce dose to 25 mg/m2 on Days 1 and 2
- 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 may be considered (2.1)
Non-Hodgkin's Lymphoma (NHL)
- 120 mg/m2 IV (over 30 mins) on day 1 and 2 of a 21-day cycle, upto 8 cycles
- Dose modifications for hematologic toxicity: for Grade 4 toxicity, reduce the dose to 90 mg/m2 on Days 1 and 2 of each cycle; if Grade 4 toxicity recurs, reduce the dose to 60 mg/m2 on Days 1 and 2 of each cycle
- Dose modifications for non-hematologic toxicity: For Grade 3 or greater toxicity, reduce the dose to 90 mg/m2 on Days 1 and 2 of each cycle; if Grade 3 or greater toxicity recurs, reduce the dose to 60 mg/m2 on Days 1 and 2 of each cycle
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- Mild to moderate impairment: Use with caution
- CrCl < 40 mL/min: Avoid use
Hepatic Dose Adjustment
- Mild impairment: Use with caution
- Moderate impairment (AST or ALT 2.5-10 X ULN and total bilirubin 1.5-3 X ULN): Avoid use
- Severe impairment (bilirubin > 3 X UNL): Avoid use
Hematologic Toxicity
- Delay treatment for Grade 4 hematologic toxicity or clinically significant
Grade 2 non-hematologic toxicity
See Supplemental Patient Information
- May cause myelosuppression; monitor leukocytes, platelets, hemoglobin, neutrophils closely; requires dose adjustment based on ANC and platelet count
- Severe anaphylactic/infusion reactions have occurred. Monitor and discontinue drug if severe reactions occur
- Extravasations requiring hospitalization have occurred, monitoring recommended
- Tumor lysis syndrome has been reported, usually within the first treatment cycle, and may lead to acute renal failure and death
- Adequate volume status should be maintained and potassium and uric acid concentrations should be monitored.
- Allopurinol has been are administered concomitantly, however increased risk of skin reactions
- Discontinue therapy if severe or progressive skin reactions occurred
- Pre-malignant and malignant diseases including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia and bronchial carcinoma have been reported
- Use reliable contraception during therapy and for 3 months after discontinuation in women of childbearing potential and in men with partners of childbearing potential
Cautions: Use cautiously in
- Renal impairment (refer dose adjustment section )
- Hepatic impairment (refer dose adjustment section )
Supplemental Patient Information
- Risk of myelosuppression; advise patients to report any sign of infection to the physician
Pregnancy Category:D
Breastfeeding: Most sources consider breastfeeding to be contraindicated with antineoplastic therapy. Due to the potential to cause serious adverse events in nursing infants and tumorigenicity shown in animal studies, it is recommended that patients receiving bendamustine should not breastfeed.
