Epogen - Indications & Dosage

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Patients also reported improvement in their disease symptoms. They showed a statistically significant increase in exercise capacity (VO 2 max), energy, and strength with a significant reduction in aching, dizziness, anxiety, shortness of breath, muscle weakness, and leg cramps.

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 EPOGEN (r) 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, approxi-mately 65% of the patients required doses of 100 Units/ kg TIW, or less, to main-tain 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 EPOGEN (r) subcutaneously for approxi-mately 109 patient-years of experience. Patients responded to EPOGEN (r) administered SC in a manner similar to patients receiving IV administration.

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%).