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Thrombotic Events In clinical trials where the maintenance hematocrit was 35 ± 3% on EPOGEN (r) , clotting of the vascular access (A-V shunt) has occurred at an annualized rate of about 0.25 events per patient-year, and other thrombotic events (eg, myocardial infarction, cerebral vascular accident, transient ischemic attack, and pulmonary embolism) occurred at a rate of 0.04 events per patient-year. In a separate study of 1111 untreated dialysis patients, clotting of the vascular access occurred at a rate of 0.50 events per patient-year. However, in CRF patients on hemodialysis who also had clinically evident ischemic heart disease or conges-tive heart failure, the risk of A-V shunt thrombosis was higher (39% vs 29%, p < 0.001), and myocardial infarctions, vascular ischemic events, and venous thrombosis were increased, in patients targeted to a hematocrit of 42 ± 3% compared to those maintained at 30 ± 3% (see WARNINGS). Text Continues Below
In patients treated with commercial EPOGEN (r) , there have been rare reports of serious or unusual thrombo-embolic events including migratory thrombophlebitis, microvascular thrombosis, pulmonary embolus, and thrombosis of the retinal artery, and temporal and renal veins. A causal relationship has not been estab-lished. Allergic Reactions There have been no reports of serious allergic reactions or anaphylaxis associated with EPOGEN (r) administration during clinical trials. Skin rashes and urticaria have been observed rarely and when reported have generally been mild and transient in nature. There have been rare reports of potentially serious allergic reactions including urticaria with associated respiratory symptoms or circumoral edema, or urticaria alone. Most reactions occurred in situations where a causal relationship could not be established. Symptoms recurred with rechallenge in a few instances, suggesting that allergic reactivity may occasionally be associated with EPOGEN (r) therapy. There has been no evidence for development of antibodies to erythropoietin in patients tested to date, including those receiving EPOGEN (r) for over 4 years. Nevertheless, if an anaphylactoid reaction occurs, EPOGEN (r) should be immedi-ately discontinued and appropriate therapy initiated. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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