Renogen Special Precautions

Epoetin alpha should be administered under the guidance of a physician experienced in the use of such therapy.
Hematocrit should be determined at least once a week in HIV-infected patients with zidovudine-induced anemia or cancer patients with chemotherapy-induced anemia and at least once or twice weekly in patients with anemia of chronic renal failure until it has stabilized within the desired target range; subsequence the monitoring of hematocrit should be performed at regular intervals.
If the increase in hematocrit exceeds 4% in any 2-week period, the dosage of Epoetin alpha should be reduced to minimize the possibility of adverse effects, including exacerbation of hypertension in chronic renal patients. Blood pressure monitoring is particularly important in patients with an underlying history of hypertension or cardiovascular disease.
The safety and efficacy of Epoetin alpha has not been established in patients with a preexisting seizure order, and the drug should be used with caution in such patients.
Epoetin alpha treatment should be discontinued if anaphylactoid reactions should occur. Mild and transient rash and urticaria have been reported rarely.
Patients with iron overload prior to starting therapy with the drug may not require such supplementation initially as the shift of excess iron tissues and/or the reticuloendothelial system occurs, however profound iron deficiency may develop subsequently, so monitoring serum and tissue iron stores is essential during Epoetin alpha therapy.
Compliance with concurrent drug therapy, dietary restrictions and dialysis schedules should be encouraged in chronic renal failure patients receiving Epoetin alpha therapy.
Conditions that may diminish or block the effects of Epoetin alpha include states of acute or chronic inflammation, infection, neoplastic disease or malignancy, underlying myelodysplastic disorders, marrow suppression from uremia, aluminium overload (possibly by interfering iron availability), hyperparathyroidism/osteitis fibrosa cystica, hypersplenism, acute or chronic blood loss, erythrocyte enzyme abnormalities (e.g. pyruvate kinase deficiency), and/or folic acid or Vitamin B12 deficiency.
Pure Red Cell Aplasia: In most of these PRCA patients antibodies to erythropoietins have been reported. If no cause is identified, a bone marrow examination should be considered.
If pure red cell aplasia (PRCA) is diagnosed, Epoetin must be immediately discontinued and testing for erythropoietin antibodies should be considered. If antibodies to erythropoietin are detected patients should not be switched to another ESA (Erythropoiesis-stimulating agents) product as anti-erythropoietin antibodies cross-react with other ESAs. Other causes of pure red cell aplasia should be excluded, and appropriate therapy instituted.
Use in Children: Efficacy and safety of Epoetin alpha has not been established. But the drug has been used for the treatment of anemia (e.g. anemia of chronic renal failure, anemia of prematurity) in a limited number of children younger than 12 years of age.
Use in Elderly: While safety and efficacy of Epoetin alpha have not been established specifically in geriatric patients, a large proportion of patients treated with the drug for anemia associated with chronic renal failure have been 65 years or older. Based on the clinical studies with Epoetin alpha therapy for the treatment of anemia in this age group, special precautions generally do not appear necessary for use of the drug in geriatric patients. However, because of an increased risk of renal and/ or cardiovascular complications in geriatric patient, careful monitoring of blood chemistry and blood pressure may be necessary.