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Data From Investigational Use of PROCRIT(R) (Epoetin alfa) Presented at American Society of Nephrology Annual Meeting
Date:11/7/2008

inical trials of

patients with cancer. A rate of hemoglobin rise of 1 g/dL over 2 weeks

may contribute to these risks.

-- Dose of PROCRIT

-- Chronic renal failure patients: The dose of PROCRIT should be titrated for each patient to achieve and maintain 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 patients: PROCRIT therapy should not be initiated at hemoglobin levels greater than or equal to 10 g/dL. The dose of PROCRIT should be titrated for each patient to achieve and maintain the lowest hemoglobin level sufficient to avoid the need for blood transfusion. Discontinue if after 8 weeks of therapy there is no response as measured by hemoglobin levels or if transfusions are still required (see recommended Dose Modification section in DOSAGE and ADMINISTRATION of the PROCRIT Prescribing Information).

-- HIV patients: The dose of PROCRIT should be titrated for each patient to achieve and maintain the lowest hemoglobin level sufficient to avoid transfusion and not to exceed the upper safety limit of 12 g/dL.

-- Monitor hemoglobin regularly during therapy, weekly 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 treated with PROCRIT;

predominantly 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.


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SOURCE Ortho Biotech Products, L.P.
Copyright©2008 PR Newswire.
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