Renogen Warnings

Pure Red Blood Cell Aplasia (PRCA): According to the increased incidence of antibody-mediated pure red blood cell aplasia (PRCA) in chronic renal failure patients who were administered Epoetin subcutaneously for long term treatment, as well as Hepatitis C patients who were treated Erythropoiesis-stimulating agents (ESAs) with interferon and ribavirin as combination therapy.
For those patients who poorly responsive to ESA therapy and require transfusion, a reticulocyte count testing should be investigated, in case of reticulocyte index less than 20,000/microliters 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.
Unless the test results are clear, the patient should be warned to discontinue the treatment with Epoetin including ESA therapy due to cross-reaction.
Erythropoiesis-stimulating agents (ESAs) might be associated with serious adverse events, for example, hypertension, lack of effect/efficacy(LOE), and pure red blood cell aplasia (PRCA).
According to the incidence of thrombotic vascular events (TVEs)might increase in patients who were administered ESAs, therefore the benefit-risk assessment is recommended should be observed from the treatment in patients with an increased risk of thrombotic vascular events, for example, obesity, patients with a prior history of TVEs (e.g. deep venous thrombosis or pulmonary embolism) and patients with cancer.
Patients who develop antibody-mediated Pure Red Cell Aplasia (PRCA)following treatment with Renogen, must be immediately discontinued and testing for erythropoietin antibodies should be considered.
Patients with conditions associated with thrombotic/vascular events should be closely monitored.