Eprex Special Precautions

r-HuEPO should be used with caution in those patients with uncontrolled hypertension, ischemic vascular disease, history of seizures or suspected allergy to any components of Eprex.
CRF patients should be closely monitored for changes in hemoglobin, blood pressure and serum electrolytes, because preliminary evidence suggests that hypertensive episodes (in some cases associated with hypertensive encephalopathy and seizures) are most likely to occur in patients experiencing a rapid Hb response. An increase in Hb of <2 g/dL/month is recommended. If blood pressure begins to increase or, is accompanied by headache, more aggressive antihypertensive treatment should be used. In cases where the rise in blood pressure is difficult to control, the patients should be admitted to the hospital or clinic for observation until their blood pressure is adequately controlled. No such problems with accelerated high blood pressure have been observed in AIDS patients.
At the start, all patients on r-HuEPO should have their hemoglobin levels measured no less than weekly until a stable level of 10-12 g/dL is achieved and periodically monitored thereafter.
Correction of anemia may result in increased appetite and potassium intake which in turn could lead to hyperkalemia in both dialysis and predialysis patients.
Moreover, correction of anemia in dialysis patients may result in decreased dialysis efficiency resulting in increased predialysis serum potassium, creatinine and inorganic phosphorus. These alterations in serum chemistry should be managed by dietary alterations and modifications of the dialysis prescription if appropriate.
In some preclinical toxicological studies in dogs and rats, but not in monkeys, r-HuEPO therapy was associated with subclinical bone marrow fibrosis. Bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors. The incidence of bone marrow fibrosis was not increased in a study of dialysis patients who were treated with r-HuEPO for 12-19 months compared to the incidence of bone marrow fibrosis in a matched control group of dialysis patients who had not been treated with r-HuEPO.
Based on information available to date, correction of anemia with r-HuEPO in predialysis patients does not accelerate the rate of progression of renal insufficiency.
The dialyzer should be monitored for evidence of increased clotting, and if present, an increase in dialysis heparin may be required.
In very exceptional cases, r-HuEPO therapy has been associated with exacerbation of porphyria in CRF patients. However, r-HuEPO has not caused increased urinary excretion of porphyrin metabolites in normal volunteers, even in the presence of a rapid erythropoietic response. Nevertheless, r-HuEPO should be used with caution in patients with known porphyria.
Increased serum uric acid and gouty episodes may occur in predisposed patients whose hemoglobin is rising by approximately >2 g/dL/month.
Use in children: Safety and efficacy in children have not been definitely established.