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Indication

Aranesp® (darbepoetin alfa) is indicated for the treatment of anemia... read more

Aranesp® (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. read more

Aranesp® (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.

Limitations of Use

  • Aranesp® has not been shown to improve quality of life, fatigue, or patient well-being.
  • Aranesp® is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
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Aranesp® has proven efficacy in patients on dialysis

Aranesp® provides sustained efficacy at extended dosing intervals1

Mean change in HB from baseline to evaluation

Vanrenterghem et al. Kidney Int. 2002. Data from a multicenter, randomized, open-label study comparing epoetin, given 1, 2, or 3 times weekly Intravenously or subcutaneously, with Aranesp® at a reduced dose frequency, in dialysis patients (N = 522). Dose adjustments were made as necessary and per study protocol to maintain Individual patients' Hb within a target range of -1.0 to +1.5 g/dL of their baseline Hb and between 9 g/dL and 13 g/dL for up to 52 weeks. The primary endpoint was the change in Hb between baseline and the evaluation period at weeks 25 to 32 of treatment.

Hb levels were maintained with Aranesp® QW and Q2W dosing1,2


*Represents the difference in mean change (baseline to evaluation period) in Hb levels between treatment groups in an adjusted, per-protocol analysis. To demonstrate non-inferiority, the lower limit of the 95% Cl for the difference in mean change in Hb levels between treatment groups had to be > -1.0 g/dL in the Nissenson study and > -0.5 g/dL in the Vanrenterghem study. 

This difference was not statistically significant or clinically relevant despite the reduced frequency of Aranesp® dosing.

Individualize Aranesp® QW and Q2W dosing to support erythropoiesis and intervene to address Hb changes3,4

Important Safety Information

  • Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks.
  • In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.

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Important Safety Information.

Abbreviations and References:
BIW = twice weekly; CI = confidence interval; CKD = chronic kidney disease; Hb = hemoglobin; mITT = modified intent-to-treat patients who enrolled in the study and received at least 1 dose of study drug; QW = once weekly; Q2W = once every 2 weeks; TIW = three times weekly.
References: 1. Vanrenterghem Y, Bárány P, Mann JFE, et al. Randomized trial of darbepoetin alfa for treatment of renal anemia at a reduced dose frequency compared with rHuEPO in dialysis patients. Kidney Int. 2002;62(6):2167-2175. 2. Nissenson AR, Swan SK, Lindberg JS, et al. Randomized, controlled trial of darbepoetin alfa for the treatment of anemia in hemodialysis patients. Am J Kidney Dis. 2002;40(1):110-118. 3. Aranesp® (darbepoetin alfa) prescribing information, Amgen. 4. Khan I, Krishnan M, Kothawala A, Ashfaq A. Association of dialysis facility-level hemoglobin measurement and erythropoiesis-stimulating agent dose adjustment frequencies with dialysis facility-level hemoglobin variation: a retrospective analysis. BMC Nephrol. 2011;12:22.