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 reticulocyte count, and anti-erythropoietin antibody-
associated anemia is suspected, withhold PROCRIT and other
erythropoietic proteins. Contact ORTHO BIOTECH (1-888-2ASKOBI or
1-888-227-5624) to perform assays for binding and neutralizing
antibodies. If erythropoietin antibody-mediated anemia is confirmed,
PROCRIT should be permanently discontinued and patients should not be
switched to other erythropoietic proteins.
* The safety and efficacy of PROCRIT therapy have not been established in
patients with a known history of a seizure disorder or underlying
|SOURCE Ortho Biotech Products, L.P.|
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