Hemax Warnings

The Erythropoiesis-stimulating agents (ESAs) may increase the risk of Serious Adverse Events, for example Hypertension, Lack of effect/efficacy (LOE), and Pure Red Blood Cell Aplasia (PRCA). An incidence of Thrombotic vascular events (TVEs) should be carefully weighed against the benefits to be derived from treatment with Epoetin alfa particularly in patients with pre-existing risk factors for TVEs, including obesity and prior history of TVEs eg., deep venous thrombosis, pulmonary embolism and also the cancer patients.
Pure Red Blood Cell Aplasia (PRCA): In Thailand, there has been a high report of Antibody-mediated pure red blood cell aplasia (PRCA) after administering Epoetin subcutaneous route in long term use of chronic renal failure patients. And also have an incidence of Pure Red Blood Cell Aplasia (PRCA) in patients with hepatitis C with interferon and ribavirin, when the Erythropoiesis-stimulating agents (ESAs) are used concomitantly. In chronic renal failure patient developing sudden lack of efficacy with decrease of hemoglobin and need for transfusion, a reticulocyte count should be obtained, and typical causes of non-response should be investigated. In case reticulocyte index is less than 20,000/microliter or less than 0.5% with normal platelets and white blood cells, the anti-erythropoietin antibodies and bone marrow testing should be performed to investigate the PRCA. In case of PRCA, patients should prompt to discontinue treatment with Epoetin and other ESA therapy because of the risk of cross-section.