Table 6A

ESA dosing (This table includes new dosing recommendations as released by the FDA on November 8, 2007.)

Dose and ModificationsEpoetin AlfaDarbepoetin Alfa
Initial dose 150 U/kg SC TIW 40,000 U SC weekly 2.25 mcg/kg SC weekly 500 mcg SC Q3W 
Dose increase Increase dose to 300 U/kg TIW if no reduction in transfusion requirements or rise in Hb after 8 wks Increase dose to 60,000 U SC weekly if no increase in Hb by ≥ 1 g/dL after 4 wks of therapy, in the absence of a RBC transfusion Increase dose to 4.5 mcg/kg if there is < 1 g/dL increase in Hb after 6 wks — 
Dose reductions Decrease dose by 25% when Hb reaches a level needed to avoid transfusion or Hb increases > 1 g/dL in 2 wks Decrease dose by 40% of previous dose when Hb reaches a level needed to avoid transfusion or Hb increases > 1 g/dL in 2 wks 
Dose withholding If Hb exceeds 12 g/dL, withhold dose until Hb approaches a level where transfusions may be required; restart dose at 25% below previous dose If Hb exceeds 12 g/dL, withhold dose until Hb approaches a level where transfusions may be required; restart dose at 40% below previous dose 
Dose and ModificationsEpoetin AlfaDarbepoetin Alfa
Initial dose 150 U/kg SC TIW 40,000 U SC weekly 2.25 mcg/kg SC weekly 500 mcg SC Q3W 
Dose increase Increase dose to 300 U/kg TIW if no reduction in transfusion requirements or rise in Hb after 8 wks Increase dose to 60,000 U SC weekly if no increase in Hb by ≥ 1 g/dL after 4 wks of therapy, in the absence of a RBC transfusion Increase dose to 4.5 mcg/kg if there is < 1 g/dL increase in Hb after 6 wks — 
Dose reductions Decrease dose by 25% when Hb reaches a level needed to avoid transfusion or Hb increases > 1 g/dL in 2 wks Decrease dose by 40% of previous dose when Hb reaches a level needed to avoid transfusion or Hb increases > 1 g/dL in 2 wks 
Dose withholding If Hb exceeds 12 g/dL, withhold dose until Hb approaches a level where transfusions may be required; restart dose at 25% below previous dose If Hb exceeds 12 g/dL, withhold dose until Hb approaches a level where transfusions may be required; restart dose at 40% below previous dose 

NOTE. New label text is shown in bold type.

Abbreviations: ESA, erythropoiesis-stimulating agent; FDA, US Food and Drug Administration; SC, subcutaneous; TIW, three times per week; Q3W, every 3 weeks; Hb, hemoglobin; wk, week.

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