Procrit Indications & Dosage

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Procrit - Indications & Dosage [Epoetin alfa]

Patients were randomized to PROCRIT 150 Units/ kg or placebo subcutaneously (T. I. W.) for 12 weeks. PROCRIT therapy was associated with a significantly (p< 0.008) greater hematocrit response than in the corresponding placebo-treated patients (see TABLE). 25 HEMATOCRIT (%): MEAN CHANGE FROM BASELINE TO FINAL VALUE a STUDY PROCRIT PLACEBO Chemotherapy 7.6 1. 3 Cisplatin 6.9 0. 6 a Significantly higher in PROCRIT patients than in placebo patients (p < 0.008) In the two types of chemotherapy studies [utilizing a PROCRIT dose of 150 Units/ kg (T. I. W.)] the mean number of units of blood transfused per patient after the first month of therapy was significantly (p < 0.02) lower in patients treated with PROCRIT (0.71 units in Months 2, 3) than in corresponding placebo-treated patients (1.84 units in Months 2, 3). Moreover, the proportion of patients transfused during Months 2 and 3 of therapy combined was significantly (p < 0.03) lower in the patients treated with PROCRIT than in the corresponding placebo-treated patients (22% versus 43%).

Comparable intensity of chemotherapy in the PROCRIT and placebo groups in the chemotherapy trials was suggested by a similar area under the neutrophil time curve in patients treated with PROCRIT and placebo-treated patients as well as by a similar proportion of patients in groups treated with PROCRIT and placebo-treated groups whose absolute neutrophil counts fell below 1,000 cells/ 無. Available evidence suggests that patients with lymphoid and solid cancers respond equivalently to PROCRIT therapy, and that patients with or without tumor infiltration of the bone marrow respond equivalently to PROCRIT therapy.

Surgery Patients

PROCRIT has been studied in a placebo-controlled, double-blind trial enrolling 316 patients scheduled for major, elective orthopedic hip or knee surgery who were expected to require 2 units of blood and who were not able or willing to participate in an autologous blood donation program. Based on previous studies which demonstrated that pretreatment hemoglobin is a predictor of risk of receiving transfusion, patients were stratified into one of three groups based on their pretreatment hemoglobin [ 10 (n= 2), >10 to 13 (n= 96), and >13 to 15 g/ dL (n= 218)] and then randomly assigned to receive 300 U/ kg PROCRIT, 100 U/ kg PROCRIT or placebo by subcutaneous injection for 10 days before surgery, on the day of surgery, and for four days after surgery 18 .