Usual Adult Dose for Hairy Cell Leukemia

4 mg/m2 IV by bolus injection OR diluted in a larger volume and given over 20 to 30 minutes every other week (higher doses are not recommended)

Duration of therapy: In the absence of major toxicity and with continuing improvement, treat until complete response; although not required, the administration of 2 additional doses has been recommended following complete response.

Comments:

• Patients should be hydrated with 500 to 1000 mL of 5% dextrose in 0.5 normal saline or equivalent before this drug is administered; an additional 500 mL should be administered after this drug is given.
• Assess response to therapy after 6 months.
• Continue therapy if patient achieves at least a partial response after 6 months.
• Discontinue therapy if patient has not achieved at least a partial response after 6 months.
• Discontinue therapy if patient has only a partial response after 12 months.
• Withhold therapy in patients with active infection until the infection is controlled.

Renal Dose Adjustments

• Patients with impaired renal function should be treated only when the benefit justifies the risk.
• CrCl less than 60 mL/min: Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Severe Adverse Reactions:

• Withhold therapy in patients with severe rash,
• Withhold or discontinue therapy in patients showing evidence of nervous system toxicity.

• Withhold dose and determine creatinine clearance. There are insufficient data to recommend a starting or a subsequent dose for patients with impaired renal function (creatinine clearance less than 60 mL/min).

• No dose reduction is recommended at the start of therapy in patients with anemia, neutropenia, or thrombocytopenia.
• No dose reduction is recommended during therapy in patients with anemia and thrombocytopenia if they can be supported hematologically.
• Temporarily withhold therapy if the absolute neutrophil count falls during below 200 cells/mm3 in a patient who had an initial neutrophil count greater than 500 cells/mm3; resume when count returns to predose levels.

Precautions

US BOXED WARNINGS:

• This drug should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.
• The use of higher doses than those specified is not recommended. Dose-limiting severe renal, liver, pulmonary, and CNS toxicities occurred in studies that used higher doses (20 to 50 mg/m2 in divided doses over 5 days) than recommended.
• In an investigation in patients with refractory chronic lymphocytic leukemia using this drug at the recommended dose in combination with fludarabine phosphate, 4 of 6 patients had severe or fatal pulmonary toxicity; therefore, the use of this drug in combination with fludarabine phosphate is not recommended.

• Hypersensitivity to the active component or any of the ingredients

Dialysis

Data not available

Other Comments

Storage requirements:

• Store in refrigerator at 2C to 8C (36F to 46F) for the period stated on the package.
• Vials reconstituted or reconstituted and further diluted may be stored at room temperature and ambient light but should be used within 8 hours.

• Compatible with sterile water, 5% dextrose, and 0.9% sodium chloride.