Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epoetin alfa) Label Reflects Recommendations from Recent FDA Advisory Committe...(h a Dear Health Care Provider letter i...)

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.

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 increased the rate of deep venous thromb
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