Table 6

ESA dosing (The doses contained in the FDA label as of March 2007 [shown below] have been revised. The November 8, 2007, FDA label is shown in Table 6A in the Appendix.)

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 wk Increase dose to 60,000 U SC weekly if no increase in Hb by ≥1 g/dL after 4 wk 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 wk  
Dose reductions Decrease dose by 25% when Hb approaches 12 g/dL or Hb increases >1 g/dL in 2 wk Decrease dose by 40% of previous dose when Hb exceeds 11 g/dL or Hb increases >1 g/dL in 2 wk 
Dose withholding If Hb exceeds 12 g/dL, withhold dose until Hb <11 g/dL; restart dose at 25% below previous dose If Hb exceeds 12 g/dL, withhold dose until Hb = 11 g/dL; 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 wk Increase dose to 60,000 U SC weekly if no increase in Hb by ≥1 g/dL after 4 wk 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 wk  
Dose reductions Decrease dose by 25% when Hb approaches 12 g/dL or Hb increases >1 g/dL in 2 wk Decrease dose by 40% of previous dose when Hb exceeds 11 g/dL or Hb increases >1 g/dL in 2 wk 
Dose withholding If Hb exceeds 12 g/dL, withhold dose until Hb <11 g/dL; restart dose at 25% below previous dose If Hb exceeds 12 g/dL, withhold dose until Hb = 11 g/dL; restart dose at 40% below previous dose 

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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