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WARNING

FLUDARA (fludarabine) FOR INJECTION should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. FLUDARA (fludarabine) FOR INJECTION can severely suppress bone marrow function. When used at high doses in doseranging studies in patients with acute leukemia, FLUDARA (fludarabine) FOR INJECTION was associated with severe neurologic effects, including blindness, coma, and death. This severe central nervous system toxicity occurred in 36% of patients treated with doses approximately four times greater (96 mg/m²/day for 5-7 days) than the recommended dose. Similar severe central nervous system toxicity, including coma, seizures, agitation and confusion, has been reported in patients treated at doses in the range of the dose recommended for chronic lymphocytic leukemia.

Instances of life-threatening and sometimes fatal autoimmune phenomena such as hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evans syndrome, and acquired hemophilia have been reported to occur after one or more cycles of treatment with FLUDARA (fludarabine) FOR INJECTION. Patients undergoing treatment with FLUDARA (fludarabine) FOR INJECTION should be evaluated and closely monitored for hemolysis.

In a clinical investigation using FLUDARA (fludarabine) FOR INJECTION in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL), there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of FLUDARA (fludarabine) FOR INJECTION in combination with pentostatin is not recommended.