Xigris (drotrecogin alfa (activated)) to be withdrawn due to lack of efficacy
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Drotrecogin alfa (activated), Xigris, label
DESCRIPTION Xigris (drotrecogin alfa (activated)) is a recombinant form of human Activated Protein C. An established human cell line possessing the complementary DNA for the inactive human Protein C zymogen secretes the protein into the fermentation medium. Fermentation is carried out in a nutrient medium containing the antibiotic geneticin sulfate. Geneticin sulfate is not detectable in the f...
متن کاملDrotrecogin alfa activated in clinical practice and the current evidences.
BACKGROUND AND OBJECTIVES The debate on efficacy and patient safety related to the use of drotrecogin alfa (DrotAA) is timely, principally due to the negative results observed in clinical studies performed after the PROWESS study, and the economic cost-related impact of the drug on the healthcare system. The aim of this study was to review the main studies on the use of DrotAA in patients with ...
متن کاملExtended evaluation of recombinant human activated protein C United States Trial (ENHANCE US): a single-arm, phase 3B, multicenter study of drotrecogin alfa (activated) in severe sepsis.
STUDY OBJECTIVE To gather additional 28-day all-cause mortality and safety data among adult patients with severe sepsis who were treated with drotrecogin alfa (activated). DESIGN Prospective, single-arm, multicenter clinical trial. SETTING Eighty-five study sites in the United States and two in Puerto Rico. PARTICIPANTS Adult patients (273 patients) with a diagnosis of severe sepsis, whic...
متن کاملCost-effectiveness of drotrecogin alfa (activated) for the treatment of severe sepsis in Germany.
Drotrecogin alfa (activated) (Xigris; Eli Lilly and Company, Indianapolis, IN) significantly reduced mortality in severe sepsis in the PROWESS trial. We evaluate the cost-effectiveness of drotrecogin alfa (activated) as an adjunct to standard therapy from the German healthcare payer's perspective with respect to patients with 1) severe sepsis and 2) severe sepsis and multiple organ failure the ...
متن کاملLow-dose, off-label drotrecogin alfa (xigris) in severe sepsis.
OBJECTIVE In this article, we describe a successful low-dose, off-label usage of drotrecogin alfa (Xigris), given at 18 mcg/kg per hour, in a patient with severe sepsis who had an Acute Physiology and Chronic Health Evaluation II (APACHE II) score of 26 and multiorgan failure. PATIENT A 64-year-old man was admitted to the surgical intensive-care unit of Winthrop University Hospital in Mineola...
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تاریخ انتشار 2017