In a 6 month open-label PROCRIT® study, patients responded with decreased transfusion requirements and sustained increases in hematocrit and hemoglobin with doses of PROCRIT® up to 300 Units/kg TIW.^23-25

Responsiveness to PROCRIT® therapy may be blunted by intercurrent infectious/inflammatory episodes and by an increase in zidovudine dosage. Consequently, the dose of PROCRIT® must be titrated based on these factors to maintain the desired erythropoietic response.

Cancer Patients on Chemotherapy

Adult Patients

Efficacy in patients with anemia due to concomitant chemotherapy was demonstrated based on reduction in the requirement for RBC transfusions.

Three-Times Weekly (TIW) Dosing

PROCRIT® administered TIW has been studied in a series of six placebo-controlled, double-blind trials that enrolled 131 anemic cancer patients receiving PROCRIT® or matching placebo. Across all studies, 72 patients were treated with concomitant non cisplatin-containing chemotherapy regimens and 59 patients were treated with concomitant cisplatin-containing chemotherapy regimens. Patients were randomized to PROCRIT® 150 Units/kg or placebo subcutaneously TIW for 12 weeks in each study.

The results of the pooled data from these six studies are shown in the table below. Because of the length of time required for erythropoiesis and red cell maturation, the efficacy of PROCRIT® (reduction in proportion of patients requiring transfusions) is not manifested until 2 to 6 weeks after initiation of PROCRIT®.

Proportion of Patients Transfused During Chemotherapy (Efficacy Population^a)

Intensity of chemotherapy in the above trials was not directly assessed, however the degree and timing of neutropenia was comparable across all trials. Available evidence suggests that patients with lymphoid and solid cancers respond similarly to PROCRIT® therapy, and that patients with or without tumor infiltration of the bone marrow respond similarly to PROCRIT® therapy.

Weekly (QW) Dosing

PROCRIT® was also studied in a placebo-controlled, double-blind trial utilizing weekly dosing in a total of 344 anemic cancer patients. In this trial, 61 (35 placebo arm and 26 in the PROCRIT® arm) patients were treated with concomitant cisplatin containing regimens and 283 patients received concomitant chemotherapy regimens that did not contain cisplatinum. Patients were randomized to PROCRIT®40,000 Units weekly (n = 174) or placebo (n = 170) SC for a planned treatment period of 16 weeks. If hemoglobin had not increased by > 1 g/dL after 4 weeks of therapy or the patient received RBC transfusion during the first 4 weeks of therapy, study drug was increased to 60,000 Units weekly. Forty-three percent of patients in the Epoetin alfa group required an increase in PROCRIT® dose to 60,000 Units weekly. ²³

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