Epogen

[Epoetin alfa]

Indications & Dosage
INDICATIONS AND USAGE

Treatment of Anemia of Chronic Renal Failure Patients

EPOGEN (r) is indicated for the treatment of anemia associated with CRF, including patients on dialysis (ESRD) and patients not on dialysis. EPOGEN (r) is indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determinations) and to decrease the need for transfusions in these patients.

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Non-dialysis patients with symptomatic anemia considered for therapy should have a hematocrit less than 30%. EPOGEN (r) is not intended for patients who require immediate correction of severe anemia. EPOGEN (r) may obviate the need for maintenance transfusions but is not a substitute for emergency transfusion. Prior to initiation of therapy, the patient's iron stores should be evaluated. Transferrin saturation should be at least 20% and ferritin at least 100 ng/ mL.

Blood pressure should be adequately controlled prior to initiation of EPOGEN (r) therapy, and must be closely monitored and controlled during therapy. EPOGEN (r) should be administered under the guidance of a qualified physician (see DOSAGE AND ADMINISTRATION).

Treatment of Anemia in Zidovudine-treated HIV-infected Patients

EPOGEN (r) is indicated for the treatment of anemia related to therapy with zidovudine in HIV-infected patients. EPOGEN (r) is indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determinations) and to decrease the need for transfusions in these patients.

EPOGEN (r) is not indicated for the treatment of anemia in HIV-infected patients due to other factors such as iron or folate deficiencies, hemolysis, or gastrointesti-nal bleeding, which should be managed appropriately.

EPOGEN (r) , at a dose of 100 Units/ kg TIW, is effective in decreasing the transfu-sion requirement and increasing the red blood cell level of anemic, HIV-infected patients treated with zidovudine, when the endogenous serum erythropoietin level is 500 mUnits/ mL and when patients are receiving a dose of zidovudine 4200 mg/ week.

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