Bendamustine Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Chronic Lymphocytic Leukemia

Recommended dose: 100 mg/m2 administered intravenously on days 1 and 2 of a 28 day cycle, up to 6 cycles. Bendamustine is intended for administration as an intravenous infusion over 30 minutes.

Consider using allopurinol as prevention for patients at high risk of tumor lysis syndrome for the first few weeks of treatment.

Bendamustine administration should be delayed in the event of grade 4 hematologic toxicity or clinically significant greater than or equal to grade 2 nonhematologic toxicity. Once nonhematologic toxicity has recovered to less than or equal to grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) greater than or equal to 1 x 10^9/L, platelets greater than or equal 75 x 10^9/L], bendamustine can be reinitiated at the discretion of the treating physician. Dose delays 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 nonhematologic 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 reescalation in subsequent cycles may be considered at the discretion of the treating physician.

Usual Adult Dose for non-Hodgkin's Lymphoma

Recommended dose: 120 mg/m2 intravenously on days 1 and 2 of a 21 day cycle for up to 8 cycles. Bendamustine is intended for administration as an intravenous infusion over 60 minutes.

Bendamustine administration should be delayed in the event of a grade 4 hematologic toxicity or clinically significant greater than or equal to grade 2 nonhematologic toxicity. Once nonhematologic toxicity has recovered to less than or equal to grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) greater than or equal to 1 x 10^9/L, platelets greater than or equal 75 x 10^9/L], bendamustine can be reinitiated at the discretion of the treating physician. In addition, dose reduction may be warranted.

Dose modifications for hematologic toxicity: for grade 4 or greater toxicity, reduce the dose to 90 mg/m2 on days 1 and 2 of each cycle; if grade 4 or greater toxicity recurs, reduce the dose to 60 mg/m2 on days 1 and 2 of each cycle.

Dose modifications for nonhematologic 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.

Renal Dose Adjustments

Bendamustine should be used with caution in patients with mild or moderate renal impairment. Bendamustine should not be used in patients with a CrCl less than 40 mL/min.

Liver Dose Adjustments

Bendamustine should be used with caution in patients with mild hepatic impairment. Bendamustine should not be used in patients with moderate (AST or ALT 2.5 to 10 X ULN and total bilirubin 1.5 to 3 X ULN) or severe (total bilirubin greater than 3 X ULN) hepatic impairment.

Precautions

The effectiveness of bendamustine has not been established in pediatric patients (less than 18 years of age). The safety profile in pediatric patients was consistent with that seen in adults.

Dialysis

Bendamustine should not be used in patients with a CrCl less than 40 mL/min.

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