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

itional benefit.  Use caution in patients with coexistent cardiovascular disease and stroke.  Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients.  A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks.
  • In controlled clinical trials of patients with cancer, PROCRIT and other ESAs increased the risks for death and serious adverse cardiovascular reactions.  These adverse reactions included myocardial infarction and stroke.
  • In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.

  • Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients With Cancer

    • ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival.  These findings were observed in studies of patients with advanced head and neck cancer receiving radiation therapy, in patients receiving chemotherapy for metastatic breast cancer or lymphoid malignancy, and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy.

    Hypertension

    • PROCRIT is contraindicated in patients with uncontrolled hypertension.  Following initiation and titration of PROCRIT, approximately 25% of patients on dialysis required initiation of or increases in antihypertensive therapy; hypertensive encephalopathy and seizures have been reported in patients with CKD receiving PROCRIT.  
    • Appropriately control hypertension prior to initiation of and during treatment with PROCRIT.  Reduce or withhold PROCRIT if
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    SOURCE Janssen Products, LP
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