Procrit - Indications & Dosage

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The proportion of children achieving a hematocrit of 30%, or an increase in hematocrit of 6 percentage points over baseline, at any time during the first 12 weeks was higher in the PROCRIT arm (96% vs 58%). Within 12 weeks of initiating PROCRIT 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 PROCRIT, 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 PROCRIT for approximately 67 patient-years of experience. These patients responded to PROCRIT 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 PROCRIT was administered by either an intravenous (IV) or subcutaneous (SC) route, with similar rates of rise of hematocrit when PROCRIT was administered by either route. Moreover, PROCRIT doses of 75-150 Units/ kg per week have been shown to maintain hematocrits of 36-38% for up to six months. Correcting the anemia of progressive renal failure will allow patients to remain active even though their renal function continues to decrease.

Zidovudine-Treated HIV-Infected Patients

PROCRIT has been studied in four placebo-controlled trials enrolling 297 anemic (hematocrit < 30%) HIV-infected (AIDS) patients receiving concomitant therapy with zidovudine, (all patients were treated with Epoetin alfa manufactured by Amgen Inc.). In the subgroup of patients (89/ 125 PROCRIT, and 88/ 130 placebo) with prestudy endogenous serum erythropoietin levels 500 mUnits/ mL PROCRIT reduced the mean cumulative number of units of blood transfused per patient by approximately 40%, as compared to the placebo group.