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Ortho Biotech Statement On JAMA Publication Regarding Erythropoiesis-Stimulating Agents
Date:2/26/2008

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

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

hematologic disease (e.g., sickle cell anemia, myelodysplastic

syndromes or hypercoagulable disorders).

-- In some female patients, menses have resumed following PROCRIT therapy;

the possibility of pregnancy should be discussed and the
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SOURCE Ortho Biotech
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