Fludarabine Tablets
Generic name: fludarabine phosphate
Dosage form: tablets
Drug class:Antimetabolites
Medically reviewed by Drugs.com. Last updated on Jan 24, 2022.
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- Indications and Usage
- Dosage and Administration
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- Contraindications
- Warnings and Precautions
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- Use In Specific Populations
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
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Severe neurologic effects, including blindness, coma, and death were observed in dose-ranging studies in patients with acute leukemia when fludarabine phosphate was administered at high doses. This severe central nervous system toxicity occurred in 36% of patients treated with doses approximately four times greater (96 mg/m2/day for 5 days to 7 days) than the recommended intravenous dose (25 mg/m2/day). Similar severe central nervous system toxicity has been rarely (≤0.2%) reported in patients treated at doses in the range of the dose recommended for chronic lymphocytic leukemia. [SeeWarnings and Precautions (5.1)] Periodic neurological assessments are recommended.
Instances of life-threatening and sometimes fatal autoimmune hemolytic anemia have been reported after one or more cycles of treatment with fludarabine phosphate. Patients undergoing treatment with fludarabine phosphate should be evaluated and closely monitored for hemolysis. [SeeWarnings and Precautions (5.2)]
High incidence of fatal pulmonary toxicity was observed in a clinical investigation using fludarabine phosphate in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL). Th...
