Procrit - Warnings & Precautions

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In patients with PRCA secondary to neutralizing antibodies to erythropoietin, PROCRIT should not be administered and such patients should not be switched to another product as anti-erythropoietin anti-bodies cross-react with other erythropoietins (see ADVERSE REACTIONS).

Chronic Renal Failure Patients

Hypertension:

Patients with uncontrolled hypertension should not be treated with PROCRIT; blood pressure should be controlled adequately before initiation of therapy. Up to 80% of patients with CRF have a history of hypertension. 29 Although there does not appear to be any direct pressor effects of PROCRIT, blood pressure may rise during PROCRIT therapy. During the early phase of treatment when the hematocrit is increasing, approximately 25% of patients on dialysis may require initiation of, or increases in, antihypertensive therapy. Hypertensive encephalopathy and seizures have been observed in patients with CRF treated with PROCRIT. Special care should be taken to closely monitor and aggressively control blood pressure in patients treated with PROCRIT. Patients should be advised as to the importance of compliance with antihypertensive therapy and dietary restrictions. If blood pressure is difficult to control by initiation of appropriate measures, the hematocrit may be reduced by decreasing or withholding the dose of PROCRIT.

A clinically significant decrease in hematocrit may not be observed for several weeks. It is recommended that the dose of PROCRIT be decreased if the hematocrit increase exceeds 4 points in any two-week period, because of the possible association of excessive rate of rise of hematocrit with an exacerbation of hypertension. In chronic renal failure patients on hemodialysis with clinically evident ischemic heart disease or congestive heart failure, the hematocrit should be managed carefully, not to exceed 36% (see "Thrombotic Events"). Seizures: Seizures have occurred in patients with CRF participating in PROCRIT clinical trials. In adult patients on dialysis, there was a higher incidence of seizures during the first 90 days of therapy (occurring in approximately 2.5% of patients) as compared with later timepoints.