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Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epoetin alfa) Label Reflects Recommendations from Recent FDA Advisory Committee Meetings
Date:11/8/2007

and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:

* ESAs shortened overall survival and/or time-to-tumor progression in

clinical studies in patients with advanced breast, head and neck,

lymphoid, and non-small cell lung malignancies when dosed to target a

hemoglobin of greater than or equal to 12 g/dL.

* The risks of shortened survival and tumor progression have not been

excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL.

* To minimize these risks, as well as the risk of serious cardio- and

thrombovascular events, use the lowest dose needed to avoid red blood

cell transfusions.

* Use only for treatment of anemia due to concomitant myelosuppressive

chemotherapy.

* Discontinue following the completion of a chemotherapy course.

Perisurgery: PROCRIT(R) increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

(See WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, WARNINGS: Increased Mortality and/or Tumor Progression, and DOSAGE AND ADMINISTRATION.)

Additional changes were made in the Warnings, Dosage and Administration, and Indications and Usage sections of the label, as well as in the patient package insert to reflect the latest FDA guidance.

The Company has worked closely with the FDA to ensure that the updated PROCRIT label provides physicians and patients with the information they need to make the most appropriate and informed treatment decisions. To that end, Ortho Biotech is committed to broadly disseminating this modified prescribing information throug
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SOURCE Ortho Biotech
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