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References

  1. EPOGEN® (epoetin alfa) prescribing information, Amgen.
  2. 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: retrospective analysis. BMC Nephrol. 2011;12:22.
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The flexibility of EPOGEN® TIW (three times weekly) dosing allows for timely intervention to help address Hb changes1,2

  • 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, ESA dose, or dosing strategy that does not increase these risks.
  • Individualize dosing and use the lowest dose of EPOGEN® 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 reactions.

Considerations

  • Correct or exclude other causes of anemia before initiating EPOGEN®.
  • Evaluate the iron status of 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.
  • In pregnant women, lactating women, neonates, and infants use only single-dose vials (the benzyl alcohol-free formulation). Do not mix EPOGEN® with bacteriostatic saline (which contains benzyl alcohol) when administering to these patients.
  • Appropriately control hypertension prior to initiation of and during treatment with EPOGEN®.
  • Reduce or withhold EPOGEN® if blood pressure becomes difficult to control.

TO INITIATE EPOGEN® FOR ADULT PATIENTS

Initiate EPOGEN® treatment when the Hb level is < 10 g/dL.
The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously. The intravenous route of administration is recommended for patients on hemodialysis.

TO INITIATE EPOGEN® FOR PEDIATRIC PATIENTS (ages 1 month or older)

Initiate EPOGEN® treatment only when the Hb level is < 10 g/dL.
The recommended starting dose for pediatric patients is 50 Units/kg 3 times weekly intravenously or subcutaneously. The intravenous route of administration is recommended for patients on hemodialysis.

MONITOR AND ASSESS Hb REGULARLY

Following initiation of therapy and after each dose adjustment, monitor Hb at least weekly until the Hb level 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.

DOSAGE ADJUSTMENT

When adjusting therapy, consider Hb rate of 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:
  • Reduce or interrupt dose if the Hb level approaches or exceeds 11 g/dL.
FOR PEDIATRIC PATIENTS (ages 1 month or older):
  • Reduce or interrupt dose if the Hb level approaches or exceeds 12 g/dL.

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.

IMPORTANT SAFETY INFORMATION

  • Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with EPOGEN®.
    • This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration.
    • PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which EPOGEN® is not approved).
    • If severe anemia and low reticulocyte count develop during treatment with EPOGEN®, withhold EPOGEN® and evaluate patients for neutralizing antibodies to erythropoietin.
    • Permanently discontinue EPOGEN® in patients who develop PRCA following treatment with EPOGEN® or other erythropoietin protein drugs. Do not switch patients to other ESAs.


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Patients who do not respond adequately to EPOGEN®

  • For patients who do not respond adequately over a 12-week escalation period, increasing the EPOGEN® 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 (PRCA).
  • Discontinue EPOGEN® if responsiveness dose 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 even greater risk for cardiovascular reactions and mortality than other patients.