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Xigris (Drotrecogin Alfa (Activated)) - 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.

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Media Articles Related to Xigris (Drotrecogin Alfa)

Source: MedicineNet Hydronephrosis Specialty [2017.03.08]
Title: Sepsis
Category: Diseases and Conditions
Created: 2/6/2009 12:00:00 AM
Last Editorial Review: 3/8/2017 12:00:00 AM

Septic Shock: Does Early, Goal-Directed Therapy Help?
Source: Medscape Critical Care Headlines [2017.09.29]
A new meta-analysis from the New England Journal of Medicine clarifies whether there are any benefits from early, goal-directed therapy for sepsis.
Medscape Critical Care

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Published Studies Related to Xigris (Drotrecogin Alfa)

Endogenous plasma activated protein C levels and the effect of enoxaparin and drotrecogin alfa (activated) on markers of coagulation activation and fibrinolysis in pulmonary embolism. [2011]
INTRODUCTION: There are no published data on the status of endogenous activated protein C (APC) in pulmonary embolism (PE), and no data on the effect of drotrecogin alfa (activated) (DAA) given in addition to therapeutic dose enoxaparin... CONCLUSIONS: In patients with acute submassive PE endogenous APC levels are low. DAA infusion enhances the inhibition of fibrin formation. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00191724.

Randomized trial evaluating serial protein C levels in severe sepsis patients treated with variable doses of drotrecogin alfa (activated). [2010]
INTRODUCTION: Serial alterations in protein C levels appear to correlate with disease severity in patients with severe sepsis, and it may be possible to tailor severe sepsis therapy with the use of this biomarker. The purpose of this study was to evaluate the dose and duration of drotrecogin alfa (activated) treatment using serial measurements of protein C compared to standard therapy in patients with severe sepsis... CONCLUSIONS: The study met its primary objective of increased protein C levels in patients receiving alternative therapy demonstrating that variable doses and/or duration of drotrecogin alfa (activated) can improve protein C levels, and also provides valuable information for incorporation into potential future studies. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00386425.

A retrospective observational study of drotrecogin alfa (activated) in adults with severe sepsis: Comparison with a controlled clinical trial. [2008.01]
OBJECTIVE:: To compare characteristics and outcomes of patients treated with drotrecogin alfa (activated) (DrotAA) in clinical practice to those treated in a phase III randomized controlled trial (PROWESS)... CONCLUSIONS:: Patients treated in clinical practice differed from those in PROWESS. Patients were younger, had more comorbidities, had greater severity of illness, and had longer mean time from severe sepsis onset to the start of DrotAA. Hospital mortality for patients treated within 1 day of severe sepsis onset was similar to DrotAA-treated PROWESS patients. While the low number of serious bleeding events precludes a definitive assessment, the observed incidence of serious bleeding events in clinical practice patients was numerically higher than in DrotAA-treated PROWESS patients.

My brother has severe sepsis Should he receive Xigris(R)? [2007.12]
Six years ago, a publication in a quite well known scientific medical journal brought hope and a good dose of optimism to sepsis therapy and the critical care community. For the first time, a careful randomized controlled trial in patients with severe sepsis or septic shock seemed to show a clearly beneficial effect of a new drug, i.e...

Prophylactic heparin in patients with severe sepsis treated with drotrecogin alfa (activated). [2007.09.01]
RATIONALE: Patients with severe sepsis frequently receive prophylactic heparin during drotrecogin alfa (activated) (DrotAA) treatment due to risk of venous thromboembolic events (VTEs). Biological plausibility exists for heparin to reduce DrotAA efficacy and/or increase bleeding. OBJECTIVES: Primary: demonstrate in adult patients with severe sepsis receiving DrotAA treatment that 28-day mortality was equivalent for patients treated with concomitant prophylactic heparin compared with placebo; secondary: safety and VTE incidence... CONCLUSIONS: Compared with placebo, concomitant prophylactic heparin was not equivalent, did not increase 28-day mortality, and had an acceptable safety profile in patients with severe sepsis receiving DrotAA. Heparin discontinuation should be carefully weighed in patients considered for DrotAA treatment. XPRESS clinical trial registered with www.clinicaltrials.gov (NCT 00049777). The study ID numbers are 6743; F1K-MC-EVBR.

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Clinical Trials Related to Xigris (Drotrecogin Alfa)

Safety and Dose Finding Study of Xigris in Hemodialysis Patients [Completed]
The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an anticoagulant at different dose levels during dialysis treatment in patients with End Stage Renal Disease (ESRD).

Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis [Completed]
The purposes of this study are to determine: 1. Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated). 2. Whether drotrecogin alfa (activated) minimizes long term disabilities associated with severe sepsis. 3. The side effects that might be associated with drotrecogin alfa (activated) administration to children with severe sepsis.

Adjuvant Treatment of Pulmonary Embolism With Drotrecogin Alfa (Activated): Phase II Exploratory Study [Completed]

A Safety Evaluation of Drotrecogin Alfa (Activated) in Patients With Blood Cancer, Severe Infection Related to Bone Marrow Transplantation [Completed]
The purpose is to determine how Drotrecogin Alfa (activated) will affect patients with blood cancers who develop severe sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT).

Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated) [Completed]
In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration [24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours] or will receive the normal, approved dose or higher doses than the approved dose for a longer administration time. After the drug administration is complete, the protein C levels from the patients receiving the normal, approved dose will be compared to protein C levels from patients receiving the normal, approved dose or higher dose for a longer duration to determine if the protein C levels improve faster if given higher dose and/or longer administration time. Note: The protocol was amended to remove the option of shorter infusion durations.

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Reports of Suspected Xigris (Drotrecogin Alfa) Side Effects

Brain Death (2)Death (2)Finger Amputation (2)Brain Oedema (2)Immune System Disorder (2)Septic Shock (2)Disseminated Intravascular Coagulation (1)Cerebral Haemorrhage (1)Multi-Organ Failure (1)Myocardial Infarction (1)more >>

Page last updated: 2017-09-29

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