Anemia :: Ortho Biotech revises prescribing information for Procrit anemia drug

Ortho Biotech Products, L.P. revised the label for PROCRIT? (Epoetin alfa), acting upon guidance from the U.S. Food and Drug Administration (FDA) to revise labeling for all drugs within the erythropoiesis-stimulating agent (ESA) class.

The action is being taken in response to reports from several investigational studies evaluating ESAs. The label for all ESAs, including PROCRIT, now includes a boxed warning containing the following information:

Use the lowest dose of PROCRIT that will gradually increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell transfusion.

PROCRIT and other erythropoiesis-stimulating agents (ESAs) increased the risk for death and for serious cardiovascular events when administered to target a hemoglobin of greater than 12 grams per deciliter of blood (g/dL).

Cancer Patients: Use of ESAs:

shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a hemoglobin of greater than 12 g/dL;

shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a hemoglobin of greater than 12 g/dL;

increased the risk of death when administered to target a hemoglobin of 12 g/dL in patients with active malignant disease receiving neither chemotherapy nor radiation therapy. ESAs are not indicated for this population.

Patients receiving ESAs pre-operatively for reduction of allogeneic blood transfusions: A higher incidence of deep venous thrombosis was documented in patients receiving PROCRIT who were not receiving prophylactic anticoagulation. Antithrombotic prophylaxis should be strongly considered when PROCRIT is used to reduce allogeneic red blood cell transfusions.

The Company has worked closely with the FDA to ensure that the PROCRIT label provides physicians and patients with the information they need to make the most appropriate and informed treatment decisions.


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