EPIAO Adverse Reactions

For CRF Patients: Epiao is generally well tolerated. The adverse events reported are frequent sequelae of CRF and are not necessarily attributable to Epiao therapy. In a combined clinical trial involving 151 CRF patients, the events reported were listed in the following table.

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In all studies analyzed to date (P.R. China), Epiao administration was generally well tolerated, irrespective of the route of administration.
Hypertension: Increases in blood pressure have been reported as the main side effect in clinical trials.
Thrombotic Events: In patients treated with Epiao in P.R. China, there have been rare reports of serious or unusual thromboembolic events eg, migratory thrombophlebitis, microvascular thrombosis, pulmonary embolus, and thrombosis of the retinal artery, and temporal and renal veins. Collectively, these events have been reported in <0.0001 events per patient-year; in no case has a causal relationship been established.
Allergic Reactions: There have been no reports of serious allergic reactions or anaphylaxis associated with erythropoietin 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 cases for development of antibodies to erythropoietin in patients treated to date. In fact, a report of 13 anemic patients with CRF who developed neutralizing antibodies and PRCA after taking recombinant human erythropoietin products has been published in the New England Journal of Medicine. Nevertheless, if PRCA occurs, epoetin α should be immediately discontinued and appropriate therapy initiated.
For Cancer Patients on Chemotherapy: Adverse reactions reported in phase III clinical trials with Epiao in cancer patients were consistent with the underlying disease state. The clinical trial is designed for 3 months duration involving 121 patients. There are only 3 cases with skin reaction, 1 with hypertension and 2 with asthma and dizziness.