Ortho Biotech looks forward to working closely with the FDA to help ensure that healthcare professionals have the information they need to continue to use PROCRIT safely and effectively, particularly with respect to the issues raised in today's discussions.
About PROCRIT (Epoetin alfa)
PROCRIT can be 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
From the Boxed Warnings
-- Use the lowest dose of PROCRIT that will gradually increase the
hemoglobin (Hb) concentration to the lowest level sufficient to avoid
the need for red blood cell (RBC) transfusion.
-- PROCRIT and other erythropoiesis-stimulating agents (ESAs) increased
the risk for death and for serious cardiovascular events (including
serious arterial and venous thromboembolic events, myocardial
infarction, stroke, congestive heart failure) when administered to
target a Hb of greater than 12 g/dL. A rate of hemoglobin rise of
greater than 1 g/dL over 2 weeks may also contribute to these risks.
-- Cancer patients: Use of ESAs:
-- Shortened the time to tumor progression in patients with advanced
head and neck cancer receiving radiation therapy when administered
to target a Hb of greater than 12 g/dL.
-- Shortened overall survival and increased deaths attributed to
disease progression at 4 months in patients with metastatic breast
cancer receiving chemotherapy
|SOURCE Ortho Biotech Products, L.P.|
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