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Ortho Biotech to Submit Official Request for Reconsideration to CMS Regarding ESA Coverage Policy
Date:11/8/2007

rget a

hemoglobin of greater than or equal to 12 g/dL.

-- The risks of shortened survival and tumor progression have not been

excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL.

-- To minimize these risks, as well as the risk of serious cardio- and

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 administrati
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SOURCE Ortho Biotech
Copyright©2007 PR Newswire.
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