Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epo... (oncomitant myelosuppressive chemot...)

Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epoetin alfa)

Date:3/7/2008

oncomitant 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 section of the label to reflect these two studies.

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 disseminating this modified prescribing information through a "Dear Health Care Provider" letter, its product Web site and its product specialists.

About PROCRIT (Epoetin alfa)

PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.

Important U.S. Safety Information for PROCRIT

Boxed WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION

Renal failure: Patients experienced greater risks for death 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 withi
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Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epo...(oncomitant myelosuppressive chemot...)