-- 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 when administered to target a Hb of greater
than 12 g/dL.
-- Increased the risk of death when administered to target a Hb of 12
g/dL in patients with active malignant disease receiving neither
chemotherapy nor radiation therapy. ESAs are not indicated for this
-- Patients receiving PROCRIT pre-operatively for reduction of allogeneic
RBC transfusions: A higher incidence of deep venous thrombosis was
documented in patients receiving PROCRIT who were not receiving
prophylactic anticoagulation. Antithrombotic prophylaxis should be
strongly considered when PROCRIT is used to reduce allogeneic RBC
PROCRIT is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.
Additional Important Safety Information
-- Monitor Hb regularly during therapy, more frequently following a dosage
adjustment or until Hb becomes stable.
-- Cases of pure red cell aplasia (PRCA) and of severe anemia, with or
without other cytopenias, associated with neutralizing antibodies to
erythropoietin have been reported in patients with chronic renal
failure receiving PROCRIT by subcutaneous administration. If any
patient develops a sudden loss of response to PROCRIT, accompanied by
severe anemia and low reticulocyt
|SOURCE Ortho Biotech Products, L.P.|
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