Procrit

[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 erythropoietins have been described in publica-tions. Very rare occurrences of PRCA and the presence of antibodies with neutralizing activity have been reported since market introduction of PROCRIT in the United States (see WARNINGS: PURE RED CELL APLASIA).

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Cases have been observed in patients treated by both SC and IV routes of adminis-tration. Among reported cases where the route of administration is known, PRCA has been observed more with SC administration than IV administration.

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 PROCRIT with the incidence of antibodies to other products may be misleading.

Chronic Renal Failure Patients

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

In the U. S. PROCRIT 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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