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Events reported to have occurred within several hours of administration of
EPOGEN (r) were rare, mild, and transient, and included injection site stinging in dialysis patients and flu-like symptoms such as arthralgias and myalgias. In all studies analyzed to date, EPOGEN (r) administration was generally well-tolerated, irrespective of the route of administration. Pediatric CRF Patients In pediatric patients with CRF on dialysis, the pattern of most adverse events was similar to that found in adults. Additional adverse events reported during the double-blind phase in >10% of pediatric patients in either treatment group were: abdominal pain, dialysis access complications including access infections and peritonitis in those receiving peritoneal dialysis, fever, upper respiratory infection, cough, pharyngitis, and constipation. The rates are similar between the treatment groups for each event. Text Continues Below
Hypertension Increases in blood pressure have been reported in clinical trials, often during the first 90 days of therapy. On occasion, hypertensive encephalopa-thy and seizures have been observed in patients with CRF treated with EPOGEN (r) . When data from all patients in the US phase 3 multicenter trial were analyzed, there was an apparent trend of more reports of hypertensive adverse events in patients on dialysis with a faster rate of rise of hematocrit (greater than 4 hematocrit points in any 2-week period). However, in a double-blind, placebo-controlled trial, hypertensive adverse events were not reported at an increased rate
in the group treated with EPOGEN (r) (150 Units/ kg TIW) relative to the placebo group. Seizures There have been 47 seizures in 1010 patients on dialysis treated with EPOGEN (r) in clinical trials, with an exposure of 986 patient-years for a rate of approximately 0.048 events per patient-year. However, there appeared to be a higher rate of seizures during the first 90 days of therapy (occurring in approxi-mately 2.5% of patients) when compared to subsequent 90-day periods. The base-line incidence of seizures in the untreated dialysis population is difficult to deter-mine; it appears to be in the range of 5% to 10% per patient-year. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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