Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epo...(upport the most appropriate use of the p...)

About PREPARE and GOG-191

PREPARE was a study in patients receiving neo-adjuvant breast cancer treatment in which darbepoetin alfa was administered to prevent anemia at target hemoglobin levels of 12.5-13 g/dL. After a median follow up of approximately three years, relapse-free survival (72% versus 78%), and overall survival (86% versus 90%), were lower in darbepoetin alfa-treated patients.

GOG-191 evaluated the efficacy of maintaining hemoglobin levels between 12-14 g/dL in patients with advanced cervical cancer undergoing chemotherapy or radiotherapy. Progression-free survival (59% versus 62%) at three years, and overall survival (61% versus 71%), were lower in Epoetin alfa-treated patients.

The Boxed Warnings have been modified to now read:

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 breast, non-small cell lung, head and

neck, lymphoid, and cervical cancers 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 c
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