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

times weekly intravenously or subcutaneously.

When treating patients who have chronic kidney disease and cancer, physicians should refer to Warnings and Precautions (5.1 and 5.3).

Refer patients who self-administer PROCRIT to the Instructions for Use [see Patient Counseling Information (17)].

About PROCRIT® (Epoetin alfa)

PROCRIT is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion.  PROCRIT is indicated for the treatment of anemia due to zidovudine administered at less than or equal to 4200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of less than or equal to 500 mUnits/mL.  PROCRIT is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.  PROCRIT is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to less than or equal to 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery.  PROCRIT is not indicated for patients who are willing to donate autologous blood pre-operatively.  PROCRIT has not been shown to improve quality of life, fatigue, or patient well-being.

PROCRIT is not indicated for use:

  • In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
  • In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
  • In patients scheduled for surgery who are willing to donate autologous blood.
  • In patient
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SOURCE Janssen Products, LP
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