-- 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
-- Use only for treatment of anemia due to concomitant myelosuppressive
-- 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.
PROCRIT is contraindicated in patients with uncontrolled hypertension
or with known hypersensitivity to albumin (human) or mammalian cell-derived
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
|SOURCE Ortho Biotech Products, L.P.|
Copyright©2008 PR Newswire.
All rights reserved