Epogen

[Epoetin alfa]

Pediatric Patients on Dialysis

One hundred twenty-eight children from 2 months to 19 years of age with CRF requiring dialysis were enrolled in 4 clinical studies of EPOGEN (r) . The largest study was a placebo-controlled, randomized trial in 113 children with anemia (hematocrit 27%) undergoing peritoneal dialysis or hemodialysis.

The initial dose of EPOGEN (r) was 50 Units/ kg IV or SC TIW. The dose of study drug was titrated to achieve either a hematocrit of 30% to 36% or an absolute increase in hematocrit of 6 percentage points over baseline. At the end of the initial 12 weeks, a statistically significant rise in mean hematocrit (9.4% vs 0.9%) was observed only in the EPOGEN (r) arm. The proportion of children achieving a hematocrit of 30%, or an increase in hematocrit of 6 per-centage points over baseline, at any time during the first 12 weeks was higher in the EPOGEN (r) arm (96% vs 58%).

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Within 12 weeks of initiating EPOGEN (r) therapy, 92.3% of the pediatric patients were transfusion-independent as compared to 65.4% who received placebo. Among patients who received 36 weeks of EPOGEN (r) , hemodialysis patients required a higher median maintenance dose (167 Units/ kg/ week [n = 28] vs 76 Units/ kg/ week [n = 36]) and took longer to achieve a hematocrit of 30% to 36% (median time to response 69 days vs 32 days) than patients undergoing peritoneal dialysis.

Patients With CRF Not Requiring Dialysis

Four clinical trials were conducted in patients with CRF not on dialysis involving 181 patients treated with EPOGEN (r) for approximately 67 patient-years of experience. These patients responded to EPOGEN (r) therapy in a manner similar to that observed in patients on dialysis. Patients with CRF not on dialysis demonstrated a dose-dependent and sustained increase in hematocrit when EPOGEN (r) was administered by either an IV or SC route, with similar rates of rise of hematocrit when EPOGEN (r) was administered by either route. Moreover, EPOGEN (r) doses
of 75 to 150 Units/ kg per week have been shown to maintain hematocrits of 36% to 38% for up to 6 months. Correcting the anemia of progressive renal failure will allow patients to remain active even though their renal function continues to decrease.

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