Fludara Authorized Text

WARNING: FLUDARA FOR INJECTION should be administered under the supervision of a 6 qualified physician experienced in the use of antineoplastic therapy. FLUDARA FOR 7 INJECTION can severely suppress bone marrow function. When used at high doses in dose8 ranging studies in patients with acute leukemia, FLUDARA FOR INJECTION was associated 9 with severe neurologic effects, including blindness, coma, and death. This severe central 10 nervous system toxicity occurred in 36% of patients treated with doses approximately four times 11 greater (96 mg/m/day for 5-7 days) than the recommended dose. Similar severe central 12 nervous system toxicity, including coma, seizures, agitation and confusion, has been reported in 13 patients treated at doses in the range of the dose recommended for chronic lymphocytic 14 leukemia. 15