ATLANTA, Dec. 6 /PRNewswire/ -- Data from 11 PROCRIT(R) (Epoetin alfa) studies will be presented at the American Society of Hematology (ASH) 49th Annual Meeting and Exposition December 8 - 11, 2007.
In some cases, the data are from investigational studies and do not reflect current U.S. Food and Drug Administration (FDA)-approved PROCRIT indications or recommended dosage and administration. Please note that all information presented at ASH is embargoed for media release until the data are made available to the public on the ASH Web site.
Data on the Potential Impact on Blood Supply of Limiting ESA Use for Chemotherapy Patients
Data on PROCRIT for the Investigational Treatment of Transfusion-Dependent Anemia in MDS Patients
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 within the range of 10 to 12 g/dL.
Perisurgery: PROCRIT increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.
Contraindications
PROCRIT is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.
Please visit www.procrit.com for the full Prescribing Information, including the Boxed WARNINGS.
About Ortho Biotech Products, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients’ health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit www.orthobiotech.com.
CONTACT: Stephanie Fagan, for Ortho Biotech, +1-908-541-4029, or cell,
+1-201-572-9581, sfagan@obius.jnj.com
Web site: http://www.orthobiotech.com/
http://www.procrit.com/