Ortho Biotech Supports FDA Advisory Committees' Recommendations on Use of ESAs in Chronic Renal Failur...(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

population.

-- 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

transfusions.

Contraindications

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.

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