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Ortho Biotech Supports FDA Advisory Committees' Recommendations on Use of ESAs in Chronic Renal Failure Patients
Date:9/11/2007

- 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 (eg, 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 need for

contraception evaluated.

-- Prior to and regularly during PROCRIT therapy monitor iron status;

transferrin saturation should be greater than or equal to 20% and

ferritin should be greater than or equal to 100 ng/mL. During therapy

absolute or functional iron deficiency may develop and all patients

will eventually require supplemental iron to adequately support

erythropoiesis stimulated by PROCRIT.

-- In studies, the most common side effects included fever (pyrexia),

diarrhea, nausea, vomiting, swelling of hands or feet (edema), lack or

loss of strength or weakness (asthenia, fatigue), shortness of breath,

high blood pressure, headache, joint pain (arthralgias), abnormal skin

sensations (as tingling or tickling or itching or burning;

paresthesia), rash, constipation, and upper respiratory infection.

Please visit http://www.procrit.com for the full Prescribing Information, including the Boxed Warning.

About Ortho Biotech Products, L.P.

Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biote
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SOURCE Ortho Biotech Products, L.P.
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