Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epoetin alfa) Label Reflects Recommendations from Recent FDA Advisory Committe...( BRIDGEWATER N.J. Nov. 8 /- Ortho ...)

BRIDGEWATER, N.J., Nov. 8 /PRNewswire-FirstCall/ -- Ortho Biotech Products, L.P. today modified prescribing information for PROCRIT(R) (Epoetin alfa), following guidance from the U.S. Food and Drug Administration (FDA) to revise labeling for all drugs within the erythropoiesis-stimulating agent (ESA) class.

The modifications to the label are based on previously reported data and include recommendations from the May 10th FDA Oncologic Drugs Advisory Committee meeting, and the September 11th joint Cardiovascular and Renal Drugs Advisory Committee/Drug Safety & Risk Management Advisory Committee meeting.

"We remain confident in the safety and efficacy of PROCRIT when used according to its FDA-approved label," said Craig Tendler, M.D., Vice President, Medical Affairs, Oncology/ Nephrology, Ortho Biotech Products, L.P. "This label supports physicians' abilities to customize treatment to individual patients' needs by directing them to utilize the lowest dose needed to avoid transfusions and not to exceed an upper hemoglobin safety limit of 12 grams per deciliter (g/dL)."

Label Change Details

The modifications to the label include a hemoglobin target range of 10-12 g/dL of blood for chronic renal failure patients with anemia; a hemoglobin upper limit of 12 g/dL of blood for oncology patients with anemia due to chemotherapy; and additional data regarding 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 greater than or equal to 12 g/dL. In addition, recommendations have been added for managing chronic renal failure patients who respond poorly to ESA therapy.

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
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