XIGRIS SUMMARY
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 final product. Human Protein C is enzymatically activated by cleavage with thrombin and subsequently purified.
Xigris is indicated for the reduction of mortality in adult patients with severe sepsis (sepsis associated with acute organ dysfunction) who have a high risk of death (e.g., as determined by APACHE II, see CLINICAL STUDIES).
Safety and efficacy have not been established in adult patients with severe sepsis and lower risk of death (see CLINICAL STUDIES, Long-Term Follow-Up). Safety and efficacy have not been established in pediatric patients with severe sepsis.
|
