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Data From Investigational Use of PROCRIT(R) (Epoetin alfa) Presented at American Society of Nephrology Annual Meeting
Date:11/7/2008

important insights into the potential use of extended-dosing regimens of Epoetin alfa in this patient population," said Pablo E. Pergola, M.D., Ph.D., Division of Nephrology, University of Texas Health Science Center and Renal Associates, P.A., San Antonio, Texas.

Study Design

In the study, 375 subjects averaging 70 years of age were randomized equally to one of the three dosing groups (TIW, QW and Q2W) and treated for 44 weeks. Subjects receiving PROCRIT TIW were switched to QW dosing after 22 weeks. A dose-adjustment algorithm was used to achieve a target Hb of 11.0 to 11.9 g/dL. The primary efficacy endpoint was change in Hb from baseline to the average of the last eight weeks of treatment through Week 22. Additional analyses were performed using data through Week 44.

The mean baseline estimated glomerular filtration rate was 30 mL/min/1.73 m2 and the median weekly EPO doses (IU) were 4,382, 4,364 and 6,091 for TIW, QW and Q2W groups, respectively. For the TIW, QW and Q2W groups, the mean baseline Hb was 9.6, 9.7 and 9.8 g/dL, respectively; the mean Hb increase was 1.8, 1.6 and 1.3 g/dL, respectively, and the mean final Hb was 11.4, 11.3 and 11.1 g/dL, respectively.

About PROCRIT (Epoetin alfa)

PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.

Important Safety Information

WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, and increased risk of tumor progression OR recurrence

Renal failure: Patients experienced greater risks for death and

serious cardiovascular events when
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SOURCE Ortho Biotech Products, L.P.
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