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

blood pressure becomes difficult to control.  Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions.

Seizures

  • PROCRIT increases the risk of seizures in patients with CKD.  During the first several months following initiation of PROCRIT, monitor patients closely for premonitory neurologic symptoms.  Advise patients to contact their healthcare practitioner for new-onset seizures, premonitory symptoms or change in seizure frequency.

Lack or Loss of Hemoglobin Response to PROCRIT

  • For lack or loss of hemoglobin response to PROCRIT, initiate a search for causative factors (e.g., iron deficiency, infection, inflammation, bleeding).  If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA.  In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient hemoglobin response to PROCRIT therapy.

Pure Red Cell Aplasia

  • 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 PROCRIT.  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 PROCRIT is not approved).
  • If severe anemia and low reticulocyte count develop during treatment with PROCRIT, withhold PROCRIT and evaluate patients for neutralizing antibodies to erythropoietin.  Contact Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736) to perform assays for binding and neutralizing antibodies.  Permanently discontinue PROCRIT in patients who develo
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SOURCE Janssen Products, LP
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