Epogen

[Epoetin alfa]

PRCA has been reported in a limited number of patients exposed to
EPOGEN (r) . This has been reported predominantly in patients with CRF. Any patient with loss of response to EPOGEN (r) should be evaluated for the etiology of loss of effect (see PRECAUTIONS: LACK OR LOSS OF RESPONSE).

EPOGEN (r) should be discontinued in any patient with evidence of PRCA and the patient evaluated for the presence of binding and neutralizing antibodies to EPOGEN (r) , native erythropoietin, and any other recombinant erythropoietin administered to the patient. Amgen/ Ortho Biotech Products, L. P. should be con-tacted to assist in this evaluation. In patients with PRCA secondary to neutralizing antibodies to erythropoietin, EPOGEN (r) should not be administered and such patients should not be switched to another product as anti-erythropoietin antibod-ies
cross-react with other erythropoietins (see ADVERSE REACTIONS).

Chronic Renal Failure Patients

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Hypertension:

Patients with uncontrolled hypertension should not be treated with EPOGEN (r) ; blood pressure should be controlled adequately before initiation of therapy. Up to 80% of patients with CRF have a history of hypertension. Although there does not appear to be any direct pressor effects of EPOGEN (r) , blood pressure may rise during EPOGEN (r) 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 EPOGEN (r) . Special care should be taken to closely monitor and aggressively control blood pressure in patients treated with EPOGEN (r) .

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 EPOGEN (r) . A clinically significant decrease in hematocrit may not be observed for several weeks.

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