Results from Study Evaluating PROCRIT(R) in Intensive Care Unit Patients Published in New England Journal o... (tients and 43.5% of placebo patientsexpe...)

Results from Study Evaluating PROCRIT(R) in Intensive Care Unit Patients Published in New England Journal of Medicine

Date:9/5/2007

tients and 43.5% of placebo patients experienced a serious adverse event (SAE). However, there was no significant difference between the PROCRIT and placebo groups in the overall incidence of adverse and serious adverse events. There was a significant increase in thrombotic vascular adverse events associated with PROCRIT therapy (16.5% vs. 11.5%, p=0.008; hazard ratio 1.41, 95% CI, 1.06, 1.86). Post-hoc analyses demonstrated that thrombotic vascular events were higher as compared to placebo in the PROCRIT patients who did not receive heparin at baseline (20.3% for PROCRIT vs. 12.8% for placebo, p=0.008; hazard ratio 1.58, 95% CI, 1.09, 2.28), but were not higher in patients who received heparin (12.3% for PROCRIT vs. 10.2% for placebo, p=0.41; hazard ratio 1.16, 95% CI, .075, 1.80).

About PROCRIT (Epoetin alfa)

PROCRIT can be used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.

Important U.S. Safety Information for PROCRIT

From the Boxed Warnings

-- Use the lowest dose of PROCRIT that will gradually increase the

hemoglobin (Hb) concentration to the lowest level sufficient to avoid

the need for red blood cell (RBC) transfusion.

-- PROCRIT and other erythropoiesis-stimulating agents (ESAs) increased

the risk for death and for serious cardiovascular events (including

serious arterial and venous thromboembolic events, myocardial

infarction, stroke, congestive heart failure) when administered to

target a Hb of greater than 12 g/dL. A rate of hemoglobin rise of

greater than 1 g/dL over 2
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