In patients with alkylating-agent refractory B-cell CLL


Optimal Dosing Yields Durable Responses

Recommended dosage of FLUDARA® (fludarabine phosphate) FOR INJECTION:

  • 25 mg/m2 IV for 30 minutes daily x 5 consecutive days1
  • Each 5-day course of treatment should commence every 28 days1
  • It is recommended that 3 additional cycles of FLUDARA® FOR INJECTION be administered following the achievement of a maximal response and then the drug should be discontinued1
  • The average length of therapy is approximately 6 cycles2
  • Dosage may be decreased or delayed based on evidence of hematologic or nonhematologic toxicity1
  • Recent retrospective analysis data confirm that use of the recommended dosage and treatment schedule garners a high response2



The MD Anderson Cancer Center (MDAH) study1

  • 48 patients were treated with Fludara® for 5 days every 28 days
  • Patients had advanced disease
  • Patients had previously received extensive chemotherapy

†

* Response criteria developed by the National Cancer Institute Working Group.
† The median duration of disease control was 91 weeks in the M.D. Anderson Cancer Center (MDAH) study and 65 weeks in the Southwest Oncology Group (SWOG) study. The median survival of all refractory CLL patients treated with FLUDARA FOR INJECTION was 43 weeks and 52 weeks in the MDAH and SWOG studies, respectively.

FLUDARA FOR INJECTION is indicated for the treatment of patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease had progressed during treatment with at least one standard alkylating-agent containing regimen.1

The most common adverse events reported with FLUDARA FOR INJECTION are myelosuppression, fever and chills, infection, and nausea and vomiting. Patients should be closely monitored for signs of hematologic and nonhematologic toxicity. Periodic assessment of peripheral blood counts is recommended.

REFERENCES:

WARNING: FLUDARA FOR INJECTION should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. FLUDARA FOR INJECTION can severely suppress bone marrow function. When used at high doses in dose-ranging studies in patients with acute leukemia, FLUDARA 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 to 7 days) than the recommended dose. Similar severe central nervous system toxicity has been rarely (less than or equal to 0.2%) 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 hemolytic anemia have been reported to occur after one or more cycles of treatment with FLUDARA FOR INJECTION. Patients undergoing treatment with FLUDARA FOR INJECTION should be evaluated and closely monitored for hemolysis.

In a clinical investigation using FLUDARA 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 FOR INJECTION in combination with pentostatin is not recommended.

Please see full Prescribing Information for FLUDARA®.

Distributed by Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470
Manufactured by Ben Venue Laboratories, Bedford, OH 44146