Jane S. Ricciuti, RPh, MS


September 20, 2002

In This Article

Hematopoietic Agents

(darbepoetin alfa) Injection

Manufacturer: Amgen, Inc.

Drug Approval Classification: Biologic License Application Supplement (Approval Date: 7/19/02)

New Indication: Treatment of anemia in patients with nonmyeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.

Dosing: The dosing of Aranesp is significantly different for the treatment of anemia in patients who have cancer than the dosing used for patients with chronic renal failure.

The starting dose is 2.25 mcg/kg administered as a weekly subcutaneous (SC) injection. The dose may be escalated as follows:

  • Hemoglobin < 1 g/dL increase after 6 weeks of therapy: increase Aranesp by up to 4.5 mcg/kg.

  • Hemoglobin increases by more than 1.0 g/dL in a 2-week period or exceeds 12 g/dL: reduce Aranesp dose by 25%.

  • Hemoglobin exceeds 13 g/dL: withhold Aranesp until hemoglobin falls to 12 g/dL; reinitiate dose at 25% below previous dose.

Clinical Summary: Aranesp was initially FDA approved in September 2001 for the treatment of anemia associated with chronic renal failure. Amgen conducted a randomized, placebo-controlled, double-blind, multinational study of Aranesp in patients undergoing chemotherapy. Patients received Aranesp 2.25 mcg/kg or placebo as a single weekly SC injection for up to 12 weeks. Patients on Aranesp required fewer transfusions (26%) vs placebo (60%). Patients on Aranesp who did not have an adequate response were escalated to a dosage of 4.5 mcg/kg/week. Patients that were dose escalated had a 2-g/dL increase in hemoglobin over baseline between weeks 8 and 13 vs patients not escalated, who showed an increase in hemoglobin between weeks 6 and 13.

It is recommended that the dose of Aranesp be decreased if the hemoglobin increase exceeds 1.0 g/dL in any 2-week period, because of the association of excessive rate of rise of hemoglobin with increased incidence of cardiac arrest, neurologic events, exacerbations of hypertension, congestive heart failure, vascular thrombosis/ischemia/infarction, acute myocardial infarction, and fluid overload/edema.

Pharmacokinetics: Aranesp doses studied ranged from 0.5 mcg/kg to 8.0 mcg/kg administered weekly. There is a dose response relationship with respect to hemoglobin response.

Aranesp (darbepoetin alfa) Labeling

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