Adult Patients on Dialysis: Thirteen clinical studies were conducted, involving IV administration to a total of 1010 anemic patients on dialysis for 986 patient-years of PROCRIT® therapy. In the three largest of these clinical trials, the median maintenance dose necessary to maintain the hematocrit between 30% to 36% was approximately 75 Units/kg TIW. In the US multicenter phase 3 study, approximately 65% of the patients required doses of 100 Units/kg TIW, or less, to maintain their hematocrit at approximately 35%. Almost 10% of patients required a dose of 25 Units/kg, or less, and approximately 10% required a dose of more than 200 Units/kg TIW to maintain their hematocrit at this level.

A multicenter unit dose study was also conducted in 119 patients receiving peritoneal dialysis who self-administered PROCRIT® subcutaneously for approximately 109 patient-years of experience. Patients responded to PROCRIT® administered SC in a manner similar to patients receiving IV administration.²⁰

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 PROCRIT®. 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 PROCRIT® 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 PROCRIT® arm. 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 IV or SC route, with similar rates of rise of hematocrit when PROCRIT® was administered by either route. Moreover, PROCRIT® doses of 75 to 150 Units/kg per week have been shown to maintain hematocrits of 36% to 38% for up to 6 months.^21-22

Zidovudine-treated HIV-infected Patients

Efficacy in HIV-infected patients with anemia related to therapy with zidovudine was demonstrated based on reduction in the requirement for RBC transfusions.

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.²⁴ Among those patients who required transfusions at baseline, 43% of patients treated with PROCRIT® versus 18% of placebo-treated patients were transfusion-independent during the second and third months of therapy. PROCRIT® therapy also resulted in significant increases in hematocrit in comparison to placebo. When examining the results according to the weekly dose of zidovudine received during month 3 of therapy, there was a statistically significant (p < 0.003) reduction in transfusion requirements in patients treated with PROCRIT® (n = 51) compared to placebo treated patients (n = 54) whose mean weekly zidovudine dose was ≤ 4200 mg/week.²³

Approximately 17% of the patients with endogenous serum erythropoietin levels ≤ 500 mUnits/mL receiving PROCRIT® in doses from 100 to 200 Units/kg TIW achieved a hematocrit of 38% without administration of transfusions or significant reduction in zidovudine dose. In the subgroup of patients whose prestudy endogenous serum erythropoietin levels were > 500 mUnits/mL, PROCRIT® therapy did not reduce transfusion requirements or increase hematocrit, compared to the corresponding responses in placebo-treated patients.

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