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Warnings & Precautions
WARNINGS
Pediatric Use The multidose preserved formulation contains benzyl alcohol. Benzyl alcohol has been reported to be associated with an increased incidence of neurological and other complications in premature infants which are sometimes fatal. Text Continues Below
Thrombotic Events and Increased Mortality A randomized, prospective trial of 1265 hemodialysis patients with clinically
evident cardiac disease (ischemic heart disease or congestive heart failure) was conducted in which patients were assigned to EPOGEN (r) treatment targeted to a maintenance hematocrit of either 42 ± 3% or 30 ± 3%. Increased mortality was observed in 634 patients randomized to a target hematocrit of 42% (221 deaths [35% mortality]) compared to 631 patients targeted to remain at a hematocrit of 30% (185 deaths [29% mortality]). The reason for the increased mortality observed in these studies is unknown, however, the incidence of non-fatal myocardial infarctions (3.1% vs 2.3%), vascular access thromboses (39% vs 29%), and all other thrombotic events (22% vs 18%) were also higher in the group randomized to achieve a hematocrit of 42%. Increased mortality was also observed in a randomized placebo-controlled study of EPOGEN (r) in adult patients who did not have CRF who were undergoing coronary artery bypass surgery (7 deaths in 126 patients randomized to EPOGEN (r) versus no deaths among 56 patients receiving placebo). Four of these deaths occurred during the period of study drug administration and all four deaths were associated with thrombotic events. While the extent of the population affect-ed is unknown, in patients at risk for thrombosis, the anticipated benefits of EPOGEN (r) treatment should be weighed against the potential for increased risks associated with therapy. Pure Red Cell Aplasia Pure red cell aplasia (PRCA), in association with neutralizing antibodies to native erythropoietin, has been observed in patients treated with recombinant erythro-poietins. Page: 1 | 2 | 3 | 4 | 5 | Next >>
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