Epogen - Indications & Dosage

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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.

Zidovudine-treated HIV-infected Patients

EPOGEN (r) 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. [Amgen]).

In the subgroup of patients (89/ 125 EPOGEN (r) and 88/ 130 placebo) with prestudy endogenous serum erythropoietin levels 500 mUnits/ mL, EPOGEN (r) reduced the mean cumulative number of units of blood transfused per patient by approximately 40% as compared to the placebo group. 25 Among those patients who required transfusions at baseline, 43% of patients treated with EPOGEN (r) versus 18% of placebo-treated patients were transfusion-independent during the second and third months of therapy. EPOGEN (r) therapy also resulted in significant increases in hematocrit in comparison to placebo.