Procrit Indications & Dosage

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Procrit - Indications & Dosage [Epoetin alfa]

Once the target hematocrit (32-38%) was achieved, statistically significant improvements were demonstrated for most quality of life parameters measured, including energy and activity level, functional ability, sleep and eating behavior, health status, satisfaction with health, sex life, well-being, psychological effect, life satisfaction, and happiness. Patients also reported improvement in their disease symptoms. They showed a statistically significant increase in exercise capacity (VO2 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 intravenous administration to a total of 1,010 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 30-36% was approximately 75 Units/ kg (T. I. W.). In the U. S. multicenter Phase III study, approxi-mately 65% of the patients required doses of 100 Units/ kg (T. I. W.), 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 (T. I. W.) 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 subcutaneously in a manner similar to patients receiving intra-venous 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 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 (T. I. W.). 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.