Epogen

[Epoetin alfa]

Over this dose range, approximately 95% of all patients responded with a clinically significant increase in hematocrit, and by the end of approximately 2 months of therapy virtually all patients were transfusion-independent. Changes in the quality of life of adult patients treated with EPOGEN (r) were assessed as part of a phase 3 clinical trial. 5,8 Once the target hematocrit (32% to 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 (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:

Text Continues Below

---

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.

Page:  << Prev | 1 | 2 | 3 | 4 | 5 | Next >>