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

s undergoing cardiac or vascular surgery.
  • As a substitute for RBC transfusions in patients who require immediate correction of anemia.

  • IMPORTANT SAFETY INFORMATION

    WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

    Chronic Kidney Disease:

    • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin 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.
    • Use the lowest PROCRIT dose sufficient to reduce the need for red blood cell (RBC) transfusions.

    Cancer:

    • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
    • Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology program to prescribe and/or dispense PROCRIT to patients with cancer.  To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance.
    • To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid red blood cell (RBC) transfusions.
    • Use ESAs only for anemia from myelosuppressive chemotherapy.
    • ESAs are not indicated for patients receiving myelosuppressive chemother
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    SOURCE Janssen Products, LP
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