Epogen

[Epoetin alfa]

Treatment of Anemia in Cancer Patients on Chemotherapy

EPOGEN (r) is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. EPOGEN (r) is indicated to decrease the need for transfusions in patients who will be receiving concomitant chemotherapy for a minimum of 2 months. EPOGEN (r) is not indicated for the treatment of anemia in cancer patients due to other factors such as iron or folate deficiencies, hemolysis, or gastrointestinal bleeding, which should be managed appropriately.

Reduction of Allogeneic Blood Transfusion in Surgery Patients

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EPOGEN (r) is indicated for the treatment of anemic patients (hemoglobin > 10 to 13 g/ dL) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions. 18-20 EPOGEN (r) is indicated for patients at high risk for perioperative transfusions with significant, anticipated blood loss. EPOGEN (r) is not indicated for anemic patients who are willing to donate autologous blood. The safety of the perioperative use of EPOGEN (r) has been studied only in patients who are receiving anticoagulant prophylaxis.

CLINICAL EXPERIENCE: RESPONSE TO EPOGEN (r)

Chronic Renal Failure Patients

Response to EPOGEN (r) was consistent across all studies. In the presence of adequate iron stores (see IRON EVALUATION), the time to reach the target hematocrit is a function of the baseline hematocrit and the rate of hematocrit rise.

The rate of increase in hematocrit is dependent upon the dose of EPOGEN (r) administered and individual patient variation. In clinical trials at starting doses of 50 to 150 Units/ kg TIW, adult patients responded with an average rate of hematocrit rise of:

Starting Dose Hematocrit Increase
(TIW IV) Points/ Day Points/ 2 Weeks
50 Units/ kg 0.11 1.5
100 Units/ kg 0.18 2.5
150 Units/ kg 0.25 3.5

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