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

apy when the anticipated outcome is cure.
  • Discontinue following the completion of a chemotherapy course.

  • Perisurgery:

    Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended.

    (See WARNINGS AND PRECAUTIONS: Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism, WARNINGS AND PRECAUTIONS: Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients With Cancer, INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION.)

    Contraindications

    PROCRIT is contraindicated in patients with:

    • Uncontrolled hypertension
    • Pure red cell aplasia (PRCA) that begins after treatment with PROCRIT or other erythropoietin protein drugs
    • Serious allergic reactions to PROCRIT

    PROCRIT from multidose vials contains benzyl alcohol and is contraindicated in:

    • Neonates, infants, pregnant women, and nursing mothers.  When therapy with PROCRIT is needed in neonates and infants, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol.

    Additional Important Safety Information

    Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism

    • In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 - 14 g/dL) to lower targets (9 - 11.3 g/dL), PROCRIT and other ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups.
    • Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide add
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    SOURCE Janssen Products, LP
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