Procrit

[Epoetin alfa]

Treatment of Anemia in Cancer Patients on Chemotherapy

PROCRIT is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. PROCRIT is indicated to decrease the need for transfusions in patients who will be receiving concomitant chemotherapy for a minimum of 2 months.

PROCRIT 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.

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Reduction of Allogeneic Blood Transfusion in Surgery Patients

PROCRIT 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 PROCRIT is indicated for patients at high risk for perioperative transfusions with significant, anticipated blood loss. PROCRIT is not indicated for anemic patients who are willing to donate autologous blood. The safety of the perioperative use of PROCRIT has been studied only in patients who are receiving anti-coagulant prophylaxis.

Clinical Experience:

Response to PROCRIT

Chronic Renal Failure Patients

Response to PROCRIT 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 PROCRIT administered and individual patient variation. In clinical trials at starting doses of 50-150 Units/ kg (T. I. W.), adult patients responded with an average rate of hematocrit rise of: HEMATOCRIT INCREASE STARTING DOSE (T. I. W. 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 Over this dose range, approximately 95% of all patients responded with a clinically significant increase in hematocrit, and by the end of approximately 2 months of therapy virtually all patients were transfusion-independent. Changes in the quality of life of adult patients treated with PROCRIT were assessed as part of a Phase III clinical trial.

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