Epogen

[Epoetin alfa]

Side Effects & Drug Interactions
ADVERSE REACTIONS

Immunogenicity

As with all therapeutic proteins, there is the potential for immunogenicity. Cases of antibody-induced PRCA in patients treated with recombinant human erythro-poietins have been described in publications. Very rare occurrences of PRCA and the presence of antibodies with neutralizing activity have been reported since market introduction of EPOGEN (r) in the United States (see WARNINGS: PURE RED CELL APLASIA). Cases have been observed in patients treated by both SC and IV routes of administration. Among reported cases where the route of administration is known, PRCA has been observed more with SC administration than IV administration.

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The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to EPOGEN (r) with the incidence of antibodies to other products may be misleading.

Chronic Renal Failure Patients

EPOGEN (r) is generally well-tolerated. The adverse events reported are frequent sequelae of CRF and are not necessarily attributable to EPOGEN (r) therapy. In double-blind, placebo-controlled studies involving over 300 patients with CRF, the events reported in greater than 5% of patients treated with EPOGEN (r) during the blinded phase were:

In the US EPOGEN (r) studies in adult patients on dialysis (over 567 patients), the incidence (number of events per patient-year) of the most frequently reported adverse events were: hypertension (0.75), headache (0.40), tachycardia (0.31), nausea/ vomiting (0.26), clotted vascular access (0.25), shortness of breath (0.14), hyperkalemia (0.11), and diarrhea (0.11). Other reported events occurred at a rate of less than 0.10 events per patient per year.

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