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

t least weekly until stable then monitor at least monthly.  When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability.  A single hemoglobin 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.
  • If the hemoglobin rises rapidly (e.g. more than 1 g/dL in any 2-week period), reduce the dose of PROCRIT by 25% 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.
  • Adverse reactions in greater than or equal to 5% of PROCRIT-treated patients in clinical studies were hypertension and arthralgia.

  • Chemotherapy-Induced Anemia

    • PROCRIT is not indicated for use in patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
    • PROCRIT is not indicated for use in patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.  
    • Initiate PROCRIT in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy.
    • Use the lowest dose of PROCRIT necessary to avoid RBC tran
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    SOURCE Janssen Products, LP
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