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

on of CKD in patients not yet on dialysis as well as in patients on dialysis, and untreated may lead to the requirement for blood transfusions.  As CKD severity progresses in patients not on dialysis, anemia becomes more frequent and severe, and is almost universal among patients requiring dialysis," said Thomas Schaible, Ph.D., Vice President, Medical Affairs, Janssen Products, LP.  "PROCRIT is an important treatment option for patients with CKD-associated anemia who are not on dialysis and are likely to require transfusion.  The revised label provides additional clarification to prescribers on how to use PROCRIT in this patient segment."

Additional modifications have been made to the label to conform to the guidance of the Physician's Labeling Rule (PLR) and to the Medication Guide, which is part of the full prescribing information.  The Medication Guide is a component of the ESA Risk Evaluation and Mitigation Strategy (REMS).

As part of the class-wide update for ESAs, the company is notifying health care providers about the updated prescribing information through a joint Dear Health Care Provider letter with Amgen, and will post the letter along with the updated prescribing information on the PROCRIT website, www.PROCRIT.com.

Additional Label Update Details

The CKD section of the updated Boxed Warning of the PROCRIT label now reads:

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) transfus
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SOURCE Janssen Products, LP
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