Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epo... (n the range of 10 to 12 g/dL. Cancer...)

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Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epoetin alfa)

Date:3/7/2008

n the range of 10 to 12 g/dL.

Cancer:

-- ESAs shortened overall survival and/or time-to-tumor progression in

clinical studies in patients with breast, non-small cell lung, head and

neck, lymphoid, and cervical cancers when dosed to target 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(R) 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 r
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Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epo...(n the range of 10 to 12 g/dL. Cancer...)