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PROCRIT(R) (Epoetin Alfa) Data to be Presented at American Society of Hematology Annual Meeting
Date:12/6/2007

nd

thrombovascular events, use the lowest dose needed to avoid red blood

cell transfusions.

-- Use only for treatment of anemia due to concomitant myelosuppressive

chemotherapy.

-- Discontinue following the completion of a chemotherapy course.

Perisurgery: PROCRIT increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

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

-- The dose of PROCRIT should be titrated for each patient to achieve and

maintain the following hemoglobin levels:

-- Chronic renal failure patients -- hemoglobin levels between 10

to 12 g/dL. If a patient does not attain hemoglobin levels of 10

to 12 g/dL despite 12 weeks of appropriate PROCRIT therapy, see

DOSAGE and ADMINISTRATION in the PROCRIT Prescribing

Information.

-- Cancer or HIV patients -- the lowest hemoglobin level sufficient

to avoid transfusion and not to exceed 12 g/dL.

-- Monitor hemoglobin regularly during therapy, more frequently

following a dosage adjustment or until hemoglobin 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


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SOURCE Ortho Biotech
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