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Seizures: In double-blind and open-label trials of PROCRIT in zidovudine-treated HIV-infected patients, ten patients have experienced seizures. 25 In general, these seizures appear to be related to underlying pathology such as meningitis or cerebral neoplasms, not PROCRIT therapy. Cancer Patients on Chemotherapy Text Continues Below
Adverse experiences reported in clinical trials with PROCRIT in cancer patients were consistent with the underlying disease state. In double-blind, placebo-controlled studies of up to 3-months duration involving 131 cancer patients, adverse events with an incidence > 10% in either patients treated with PROCRIT or placebo-treated patients were as indicated below. 
Although some statistically significant differences between patients treated with PROCRIT and placebo-treated patients were noted, the overall safety profile of PROCRIT appeared to be consistent with the disease process of advanced cancer. During double-blind and subsequent open-label therapy in which patients (N= 72 for total exposure to PROCRIT) were treated for up to 32 weeks with doses as high as 927 Units/ kg, the adverse experience profile of PROCRIT was consistent with the progression of advanced cancer. Based on comparable survival data and on the percentage of patients treated with PROCRIT and placebo-treated patients who discontinued therapy due to death, disease progression or adverse experiences (22% and 13%, respectively; p = 0.25), the clinical outcome in patients treated with PROCRIT and placebo-treated patients appeared to be similar. Available data from animal tumor models and measurement of proliferation of solid tumor cells from clinical biopsy specimens in response to PROCRIT suggest that PROCRIT does not potentiate tumor growth. Nevertheless, as a growth factor, the possibility that PROCRIT may potentiate growth of some tumors, particularly myeloid tumors, cannot be excluded. A randomized controlled Phase IV study is currently ongoing to further evaluate this issue. The mean peripheral white blood cell count was unchanged following PROCRIT therapy compared to the corresponding value in the placebo-treated group. 
Thrombotic/ Vascular Events: In three double-blind, placebo-controlled orthopedic surgery studies, the rate of deep venous thrombosis (DVT) was similar among Epoetin alfa and placebo-treated patients in the recommended population of patients with a pretreatment hemoglobin of >10 to 13 g/ dL. However, in 2 of 3 orthopedic surgery studies the overall rate (all pretreatment hemoglobin groups combined) of DVTs detected by postoperative ultrasonography and/ or surveillance venography was higher in the group treated with Epoetin alfa than in the placebo-treated group (11% vs. 6%). This finding was attributable to the difference in DVT rates observed in the subgroup of patients with pretreatment hemoglobin >13 g/ dL. However, the incidence of DVTs was within the range of that reported in the literature for orthopedic surgery patients. In the orthopedic surgery study of patients with pretreatment hemoglobin of >10 to 13 g/ dL which com-pared two dosing regimens (600 U/ kg weekly x 4 and 300 U/ kg daily x 15), four subjects in the 600 U/ kg weekly PROCRIT group (5%) and no subjects in the 300 U/ kg daily group had a thrombotic vascular event during the study period. In a study examining the use of Epoetin alfa in 182 patients scheduled for coronary artery bypass graft surgery, 23% of patients treated with Epoetin alfa and 29% treated with placebo experienced thrombotic/ vascular events. There were 4 deaths among the Epoetin alfa-treated patients that were associated with a thrombotic/ vascular event. A causative role of Epoetin alfa cannot be excluded (see "WARNINGS"). Drug Interactions: No evidence of interaction of PROCRIT with other drugs was observed in the course of clinical trials.
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