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References

  1. EPOGEN® (epoetin alfa) prescribing information, Amgen.
  2. Muirhead N, Keown PA, Churchill DN, et al. Dialysis patients treated with epoetin a show improved exercise tolerance and physical function: a new analysis of the Canadian Erythropoietin Study Group trial [published online ahead of print December 7, 2010]. Hemodial Int. 2010. doi: 10.1111/j.1542-4758.2010.00508.x.
  3. Muirhead N, Laupacis A, Wong C. Erythropoietin for anaemia in haemodialysis patients: results of a maintenance study (the Canadian Erythropoietin Study Group). Nephrol Dial Transplant. 1992;7(8):811-816.
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Average rate of Hb rise in 2 weeks with EPOGEN® use1

Data from 13 clinical studies involving IV administration of EPOGEN® to 1,010 anemic adult patients on dialysis. Starting doses were 50 to 150 Units/kg TIW. In the 3 largest studies, the median maintenance dose necessary to maintain the Hb between 10 and 12 g/dL was approximately 75 Units/kg TIW.
In clinical studies, more than 95% of patients receiving EPOGEN® for 3 months avoided RBC transfusion.1

A 26-week, placebo-controlled study of 118 patients examined exercise tolerance and patient-reported physical function2,3*

Increase in Hb levels from approximately 7 to 11 g/dL was associated with improved exercise tolerance

LIMITATIONS OF USE

  • EPOGEN® has not been shown to improve quality of life, fatigue, or patient well-being.
  • EPOGEN® is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.


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Patients treated with EPOGEN® showed improvement in the number of minutes walked during a treadmill stress test, gaining approximately 1 additional minute walked on the treadmill for every 1 g/dL increase in Hb.

An increase in Hb levels from approximately 7 to 11 g/dL was associated with improved patient-reported physical function
*Reanalysis of data from the Canadian Erythropoietin Study Group (CESG), a 26-week, double-blind, placebo-controlled trial of 118 patients on dialysis with anemia of CRF with an average baseline of Hb ~ 7 g/dL. Patients were randomized to receive either EPOGEN® or placebo TIW; study Hb target range was 9.5 to 13.0 g/dL. By the end of the study, average Hb increased to ~11 g/dL in the EPOGEN®-treated patients and remained unchanged in patients receiving placebo.
†SIP and KDQ are validated instruments that evaluate patient-reported outcomes.
  • Four domains from the SIP were used to assess patient-reported physical function: Physical, Home Management, Ambulation, and Body Care and Movement.
EPOGEN® has not been shown to improve quality of life, fatigue, or patient well-being.