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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® demonstrated consistent efficacy in patients with anemia due to CKD not on dialysis


De novo dosing regimens included QW (Locatelli et al) and Q2W (Suranyi et al and Silver et al).

Locatelli et al. Kidney Int. 2001. A multicenter, randomized, open-label study that evaluated whether darbepoetin alfa is effective for the treatment of anemia at a reduced dosing frequency relative to epoetin alfa in chronic renal insufficiency not yet on dialysis.

Suranyi et al. Am J Nephrol. 2003. A multicenter, open-label, single-arm study that evaluated extending the dosing interval of darbepoetin alfa to once-every-other-week administration for treatment of anemia in patients with CKD not requiring dialysis who were naive to recombinant human erythropoietin therapy.

Silver et al. Curr Med Res Opin. 2009. An open-label, multicenter, single-arm study that evaluated the efficacy and safety of darbepoetin alfa dosed every other week (Q2W) to treat anemia in subjects with CKD not receiving dialysis who were naive to ESA therapy.

*Response defined as an increase of ≥ 1.0 g/dL from baseline and a Hb concentration of ≥ 11 g/dL.

Response defined as a Hb concentration between 11 g/dL and 13 g/dL.

Response defined as a Hb concentration ≥ 11 g/dL.

For patients with CKD not on dialysis, Aranesp® is administered Q4W intravenously or subcutaneously as appropriate

Not intended to imply efficacy comparisons among products.

  • Consider initiating Aranesp® treatment only when Hb level is < 10 g/dL and the following
    considerations apply:
    • The rate of Hb decline indicates the likelihood of requiring a RBC transfusion and,
    • Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
  • If the Hb level exceeds 10 g/dL, reduce or interrupt the dose of Aranesp®, and use the lowest dose of Aranesp® sufficient to reduce the need for RBC transfusions.
  • Recommended starting dose for adult patients:
    • Q4W: 0.45 mcg/kg as an IV or SC injection once at 4 week intervals, as appropriate.
  • Recommended starting dose for pediatric patients:
    • QW: 0.45 mcg/kg as an IV or SC injection once weekly, as appropriate.
    • Q2W: 0.75 mcg/kg as an IV or SC injection once every 2 weeks, as appropriate.

Please see additional important Dosing Information

Important Safety Information

Aranesp® is contraindicated in patients with:

  • Uncontrolled hypertension
    • Pure red cell aplasia (PRCA) that begins after treatment with Aranesp® or other erythropoietin protein drugs
    • Serious allergic reactions to Aranesp®

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Important Safety Information.

Abbreviations and References:
CKD = chronic kidney disease; ESA = erythropoiesis-stimulating agent; Hb = hemoglobin; IV = intravenous; mITT = modified intent-to-treat patients enrolled in the study and received at least 1 dose of study drug; QW = once weekly; Q2W = once every 2 weeks; Q4W = once every 4 weeks; RBC = red blood cell; SC = subcutaneous; TIW = three times weekly.
References: 1. Aranesp® (darbepoetin alfa) prescribing information, Amgen. 2. Locatelli F, Olivares J, Walker R, et al. Novel erythropoiesis stimulating protein for treatment of anemia in chronic renal insufficiency. Kidney Int. 2001;60:741-747. 3. Suranyi MG, Lindberg JS, Navarro J, et al. Treatment of anemia with darbepoetin alfa administered de novo once every other week in chronic kidney disease. Am J Nephrol. 2003;23:106-111. 4. Silver MR, Geronemus R, Krause M, et al. Anemia treatment with Q2W darbepoetin alfa in patients with chronic kidney disease naive to erythropoiesis stimulating agents. Curr Med Res Opin. 2009;25:123-131.