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

sfusions.
  • Reduce dose by 25% if:
    • Hemoglobin increases greater than 1 g/dL in any 2-week period or
    • Hemoglobin reaches a level needed to avoid RBC transfusion.
  • Withhold dose if hemoglobin exceeds a level needed to avoid RBC transfusion.  Reinitiate at a dose 25% below the previous dose when hemoglobin approaches a level where RBC transfusions may be required.
  • Adverse reactions in greater than or equal to 5% of PROCRIT-treated patients in clinical studies were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis.

  • Surgery/Perisurgery

    • PROCRIT is not indicated for use in patients scheduled for surgery who are willing to donate autologous blood.
    • PROCRIT is not indicated for use in patients undergoing cardiac or vascular surgery.
    • Deep venous thrombosis prophylaxis is recommended during PROCRIT therapy.
    • Adverse reactions in greater than or equal to 5% of PROCRIT-treated patients in clinical studies were nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension.

    Anemia in Zidovudine-treated HIV-infected Patients

    • Withhold PROCRIT if hemoglobin exceeds 12 g/dL.  Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.
    • Discontinue PROCRIT if an increase in hemoglobin is not achieved at a dose of 300 Units/kg for 8 weeks.  
    • Adverse reactions in greater than or equal to 5% of PROCRIT-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation.  

    The full PROCRIT prescribing information, including Boxed
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    SOURCE Janssen Products, LP
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