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Janssen Products, LP Modifies Prescribing Information for PROCRIT® (Epoetin alfa) in Chronic Kidney Disease
Date:6/24/2011

% or more as needed to reduce rapid responses.
  • For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
  • For patients who do not respond adequately over a 12-week escalation period, increasing the PROCRIT dose further is unlikely to improve response and may increase risks.  Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions.  Evaluate other causes of anemia.  Discontinue PROCRIT if responsiveness does not improve.

  • For patients with CKD on dialysis:

    • Initiate PROCRIT treatment when the hemoglobin level is less than 10 g/dL.
    • If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of PROCRIT.
    • The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously.  For pediatric patients, a starting dose of 50 Units/kg 3 times weekly intravenously or subcutaneously is recommended.  The intravenous route is recommended for patients on hemodialysis.

    For patients with CKD not on dialysis:

    • Consider initiating PROCRIT treatment only when the hemoglobin level is less than 10 g/dL and the following considerations apply:
      • The rate of hemoglobin 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 hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of PROCRIT, and use the lowest dose of PROCRIT sufficient to reduce the need for RBC transfusions.
    • The recommended starting dose for adult patients is 50 to 100 Units/kg 3
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    SOURCE Janssen Products, LP
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