Medically reviewed by Drugs.com. Last updated on March 25, 2020.
Applies to the following strengths: 10 mg
Usual Adult Dose for:
Additional dosage information:
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.
-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.
Use: A single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms
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
Severe Adverse Reactions:
-Withhold therapy in patients with severe rash,
-Withhold or discontinue therapy in patients showing evidence of nervous system toxicity.
Elevated Serum Creatinine:
-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.
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
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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