|
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 PROCRIT treatment targeted to a maintenance hematocrit of either 42 ± 3% or 30 ± 3%. 42 Increased mortal-ity 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 increased mortality observed in these studies is unknown, however the incidence of non-fatal myocardial infarctions (3.1% vs. 2. 3%), vascular access thrombosis (39% vs. 29%) and all other throm-botic events (22% vs. 18%) were also higher in the group randomized to achieve a hematocrit of 42%. Increased mortality was observed in a randomized placebo-controlled study of PROCRIT in adult patients who did not have chronic renal failure who were undergoing coronary artery bypass surgery (7 deaths in 126 patients randomized to PROCRIT vs. no deaths among 56 patients receiving placebo). Four of these deaths occurred during the period of study drug administration and all 4 deaths were associated with thrombotic events. While the extent of the population affected is unknown, in patients at risk for thrombosis, the anticipated benefits of PROCRIT 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 erythropoietins. PRCA has been reported in a limited number of patients exposed to PROCRIT. This has been reported predominantly in patients with CRF. Any patient with loss of response to PROCRIT should be evaluated for the etiology of loss of effect (see PRECAUTIONS: LACK OR LOSS OF RESPONSE). PROCRIT should be discontinued in any patient with evidence of PRCA and the patient evaluated for the presence of binding and neutralizing antibodies to PROCRIT, native erythropoietin, and any other recombinant erythropoietin administered to the patient. Amgen/ Ortho Biotech Products, L. P. should be contacted to assist in this evaluation. Page: 1 | 2 | 3 | 4 | 5 | Next >>
|
.gif)
