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Darbepoetin alfa

(Aranesp®)

Darbepoetin alfa

Drug updated on 9/4/2024

Dosage FormInjection (intravenous/subcutaneous; 25 mcg, 40 mcg, 60 mcg, 100 mcg, 200 mcg and 300 mcg); Injection (intravenous/subcutaneous; 10 mcg/0.4 mL, 25 mcg/0.42 mL, 40 mcg/0.4 mL, 60 mcg/0.3 mL, 100 mcg/0.5 mL, 150 mcg/0.3 mL, 200 mcg/0.4 mL, 300 mcg/0.6 mL, and 500 mcg/1 mL)
Drug ClassErythropoiesis-stimulating agents
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis.
  • Indicated for the treatment of anemia due to the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.

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Summary
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  • Aranesp (darbepoetin alfa) is indicated for the treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis. It is also indicated for the treatment of anemia caused by concomitant myelosuppressive chemotherapy, with a requirement that there are a minimum of two additional months of planned chemotherapy upon initiation.
  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Prevention of Blood Transfusions: Darbepoetin alfa is probably superior to placebo (OR 0.27, 95% CI 0.11 to 0.67; moderate certainty), while epoetin alfa and beta may also be superior (OR 0.28, 95% CI 0.13 to 0.61, and OR 0.19, 95% CI 0.08 to 0.47, respectively; low certainty). Methoxy polyethylene glycol-epoetin beta and biosimilar ESAs have uncertain effects (very low certainty).
  • Hemoglobin (Hb) Levels: Darbepoetin alfa led to a significantly higher increase in Hb levels in DD-CKD patients compared to vadadustat (MD -0.19, 95% CI -0.21 to -0.17, p < 0.0001). No significant difference was observed in NDD-CKD patients (MD = -0.06, 95% CI -0.18 to 0.05, p = 0.006). HIF-PHIs (excluding vadadustat) significantly increased Hb levels compared to placebo (mean differences 1.55 to 2.46).
  • Percentage of Patients within Target Hb: A higher percentage of DD-CKD patients treated with darbepoetin alfa were within target Hb levels compared to vadadustat (MD = 0.9, 95% CI 0.86 to 0.94, p < 0.00001), with no significant difference in NDD-CKD patients (MD = 1.05, 95% CI 0.99 to 1.12, p < 0.00001).
  • Darbepoetin alfa may increase the odds of hypertension compared to placebo (OR 1.88, 95% CI 1.12 to 3.14; low certainty evidence). Epoetin alfa and epoetin beta may also increase the odds of hypertension (OR 2.10, 95% CI 1.22 to 3.59 and OR 2.17, 95% CI 1.17 to 4.00, respectively; very low to moderate certainty evidence).
  • No significant difference in serious adverse events (SAEs) was observed between vadadustat and darbepoetin alfa (RR = 0.97, 95% CI 0.94 to 1.01, p = 0.19).
  • There is no population types or subgroups information available in the reviewed studies.