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HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use Fludarabine Phosphate Injection safely and effectively. See full prescribing information for Fludarabine Phosphate Injection.
Fludarabine Phosphate Injection
Initial U.S. Approval: 1991
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WARNING: CNS TOXICITY, HEMOLYTIC ANEMIA, AND PULMONARY TOXICITY
See full prescribing information for complete boxed warning.
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Severe central nervous system toxicity occurred in 36% of patients treated with doses approximately four times greater (96 mg/m2/day for 5 to 7 days) than the recommended dose. This toxicity was seen in ≤0.2% of patients treated at the recommended dose levels (25 mg/m2). (5.1)
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Instances of life-threatening and sometimes fatal autoimmune hemolytic anemia have been reported after one or more cycles of treatment. (5.2)
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In a clinical investigation of the combination of fludarabine phosphate with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL), there was an unacceptably high incidence of fatal pulmonary toxicity. (5.6)
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INDICATIONS AND USAGE
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Fludarabine Phosphate Injection is a nucleotide metabolic inhibitor indicated for:
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The treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. Benefit in treatment-naïve or non-refractory CLL patients is not established. (1.1)
Important limitations:
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Fludarabine phosphate should not be used in patients with severe renal impairment (creatinine clearance less than 30 mL/min/1.73 m2). (5.7)
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DOSAGE AND ADMINISTRATION
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Chronic Lymphocytic Leukemia (CLL) (2.1):
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The recommended adult dose is 25 mg/m2 administered intravenously over a period of approximately 30 minutes daily for five consecutive days.
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Each 5 day course of treatment should commence every 28 days.
Renal Insufficiency (2.2):
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