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Janssen Products, LP, formerly Centocor Ortho Biotech Products, L.P., today announced updated prescribing information for PROCRIT® (Epoetin alfa) when used to treat anemia associated with chronic kidney disease (CKD) as part of a U.S. Food and Drug Administration (FDA)-approved class-wide update for erythropoiesis-stimulating agents (ESAs).

The updates include modifications to the Boxed Warning, Warnings and Precautions, Indications and Usage, and Dosage and Administration sections for CKD, which have been revised to clarify important new information based on the totality of clinical data when ESAs are used to increase hemoglobin (Hb) levels beyond labeled guidance.

The updates to the Boxed Warning include language noting the increased risk for death, serious adverse cardiovascular reactions, and stroke when ESAs are administered to target an Hb level of greater than 11 grams per deciliter (g/dL), and that the lowest dose should be used to reduce the need for red blood cell (RBC) transfusions.  Additionally, the Dosage and Administration section for patients with CKD-associated anemia who are not on dialysis has been updated to provide indication-specific guidance to prescribers considering ESA treatment.

The updated label states that for patients with CKD who are not on dialysis, physicians should consider initiating treatment with PROCRIT only when the patient's Hb level is less than 10 g/dL, the rate of Hb decline indicates the likelihood of the patient requiring an RBC transfusion, and the goal is reducing the risk of an immune response to donor antigens or other RBC transfusion-related risks. Additional guidance has been provided to reduce or interrupt the PROCRIT dose if the patient's Hb level exceeds 10 g/dL and to individualize dosing, using the lowest dose of PROCRIT sufficient to reduce the need for RBC transfusions.

"Anemia is a frequent complication 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.

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