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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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Dosing information for Aranesp® (darbepoetin alfa) for anemia due to CKD

  • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target a Hb level of greater than 11 g/dL.
  • No trial has identified a hemoglobin target level, Aranesp® dose, or dosing strategy that does not increase these risks.
  • Individualize dosing and use the lowest dose of Aranesp® sufficient to reduce the need for RBC transfusions.
  • Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events.

Considerations

  • Correct or exclude other causes of anemia before initiating Aranesp®.
  • Evaluate the iron status in all patients before and during treatment.
  • Administer supplemental iron therapy if serum ferritin is < 100 mcg/L or serum transferrin saturation is < 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy.
  • Appropriately control hypertension prior to initiation of and during treatment with Aranesp®

− Reduce or withhold Aranesp® if blood pressure becomes difficult to control.

MONITORING

Following initiation of therapy and after each dose adjustment, monitor Hb at least weekly until the Hb is stable and sufficient to minimize the need for RBC transfusion.

  • Thereafter, Hb should be monitored at least monthly, provided that Hb levels remain stable.

DOSE ADJUSTMENTS

  • When adjusting therapy, consider Hb rise, rate of decline, ESA responsiveness, and Hb variability.

− A single Hb excursion may not require a dosing change.

− Do not increase the dose more frequently than once every 4 weeks.

− Decreases in dose can occur more frequently.

− Avoid frequent dose adjustments.

REDUCE OR INTERRUPT DOSE

  • If Hb rises rapidly (eg, more than 1 g/dL in any 2-week period), reduce the dose by 25% or more as needed to reduce rapid responses.

FOR ADULT PATIENTS WITH CKD

  • On dialysis: reduce or interrupt dose if the Hb level approaches or exceeds 11 g/dL.
  • Not on dialysis: 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.

FOR PEDIATRIC PATIENTS

(LESS THAN 18 YEARS) WITH CKD

  • If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp®.

INCREASE DOSE

  • If the Hb has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25% when appropriate.

Patients Who Do Not Respond Adequately to Aranesp® 

  • For patients who do not respond adequately over a 12-week escalation period, increasing the Aranesp® dose further is unlikely to improve response and may increase risks.
  • Use the lowest dose that will maintain a Hb level sufficient to reduce the need for RBC transfusions.
  • Evaluate other causes of anemia.
  • If typical causes of lack or loss of Hb response are excluded, evaluate for pure red cell aplasia.
  • Discontinue Aranesp® if responsiveness does not improve.

Patients with CKD and an insufficient Hb response to ESA therapy or a rate of Hb rise

of > 1 g/dL over 2 weeks may be at an even greater risk for cardiovascular reactions

and mortality than other patients.

Important Safety Information

  • Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp®. Immediately and permanently discontinue Aranesp® if a serious allergic reaction occurs.
  • Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including Aranesp®) in the postmarketing setting. Discontinue Aranesp® therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected.
  • Adverse reactions (≥ 10%) in Aranesp® clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension.

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Important Safety Information.

Abbreviations and References:
CKD = chronic kidney disease; ESA = erythropoiesis-stimulating agent; Hb = hemoglobin; IV = intravenous; QW = once weekly; Q2W = once every 2 weeks; Q4W = once every 4 weeks; RBC = red blood cell; SC = subcutaneous.