Neofax 2017 Pdf Free 168
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Study 1 was a randomized, open-label, multicenter studyin 2,098 anemic women with metastatic breast cancer, who received first line orsecond line chemotherapy. This was a non inferiority study designed to rule outa 15% risk increase in tumor progression or death of epoetin alfa plus standardof care (SOC) as compared with SOC alone. The median progression free survival(PFS) per investigator assessment of disease progression was 7.4 months in eacharm (HR 1.09, 95% CI: 0.99, 1.20), indicating the study objective was not met.At the time of clinical data cutoff, 1337 deaths were reported. Median overallsurvival in the epoetin alfa plus SOC group was 17.2 months compared with 17.4months in the SOC alone group (HR 1.06, 95% CI: 0.95, 1.18). There were moredeaths from disease progression in the epoetin alfa plus SOC arm (59% vs. 56%)and more thrombotic vascular events in the epoetin alfa plus SOC arm (3% vs.1%).
Study 4 was a randomized, open-label, controlled,factorial design study in which darbepoetin alfa was administered to preventanemia in 733 women receiving neo-adjuvant breast cancer treatment. A finalanalysis was performed after a median follow-up of approximately 3 years. The3-year survival rate was lower (86% vs. 90%; HR 1.42, 95% CI: 0.93, 2.18) andthe 3-year relapse-free survival rate was lower (72% vs. 78%; HR 1.33, 95% CI:0.99, 1.79) in the darbepoetin alfa-treated arm compared to the control arm.
Study 5 was a randomized, open-label, controlled studythat enrolled 114 of a planned 460 cervical cancer patients receivingchemotherapy and radiotherapy. Patients were randomized to receive epoetin alfato maintain hemoglobin between 12 and 14 g/dL or to RBC transfusion support asneeded. The study was terminated prematurely due to an increase inthromboembolic adverse reactions in epoetin alfa-treated patients compared tocontrol (19% vs. 9%). Both local recurrence (21% vs. 20%) and distantrecurrence (12% vs. 7%) were more frequent in epoetin alfa-treated patientscompared to control. Progression-free survival at 3 years was lower in theepoetin alfa-treated group compared to control (59% vs. 62%; HR 1.06, 95% CI:0.58, 1.91). Overall survival at 3 years was lower in the epoetin alfa-treatedgroup compared to control (61% vs. 71%; HR 1.28, 95% CI: 0.68, 2.42).
Epogen from multiple-dose vials contains benzyl alcoholand is contraindicated in pregnant women [see CONTRAINDICATIONS]. Whentherapy with Epogen is needed during pregnancy, use a benzyl alcohol-freeformulation (i.e., single-dose vial). Do not mix Epogen with bacteriostaticsaline when administering to pregnant women because it contains benzyl alcohol (seeClinical Considerations) [see DOSAGE AND ADMINISTRATION].
The multiple-dose vials are formulated with benzylalcohol and are contraindicated for use in neonates and infants [see CONTRAINDICATIONS,WARNINGS AND PRECAUTIONS]. When therapy with Epogen is needed inneonates and infants, use the single-dose vial, which is a benzyl alcohol-freeformulation. Do not mix the single-dose vials with bacteriostatic saline whenadministering Epogen to neonates or infants because it contains benzyl alcohol [seeDOSAGE AND ADMINISTRATION]. 2b1af7f3a8
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