Xigris is a powder that is made up into a solution for infusion (drip into a vein). It contains the active substance drotrecogin alfa (activated).
|Table of Contents|
|What is it used for?|
|How is it used?|
|How does it work?|
|How has it been studied?|
|What benefits has it shown during the studies?|
|What is the risk associated?|
|Why has it been approved?|
Xigris is used in adult patients with severe sepsis. Sepsis is a condition when bacteria get into the bloodstream and produce harmful substances (toxins). The toxins cause the patient?s organs to fail, such as the heart, lungs and kidneys. Xigris is used when the patient has two or more organs failing, in addition to best standard care such as antibiotics, medicines to support the organs and treatment in a specialised unit. Xigris should be used mainly when it can be started within 24 hours of the organ failure. It is intended for short-term use.
The medicine can only be obtained with a prescription.
Xigris should be used by experienced doctors in institutions skilled in the care of patients with severe sepsis.
The recommended dose of Xigris is 24 micrograms per kilogram body weight per hour, given as a continuous infusion for 96 hours. Giving Xigris using an infusion pump is the recommended way to ensure that infusion rates are well controlled. Xigris should be started within 48 hours, and preferably within 24 hours, after the start of organ failure.
Excessive blood clotting is a problem during severe sepsis, because blood clots can block the blood supply to important parts of the body such as the kidneys and lungs. Xigris is an anticoagulant, which means that it stops the blood coagulating (clotting). The active substance in Xigris, drotrecogin alfa (activated), is very similar to a natural anticoagulant found in the body called activated protein C. Drotrecogin alfa is produced by a method known as ?recombinant DNA technology?: it is made by a cell that has received a gene (DNA), which makes it able to produce drotrecogin alfa. In the body, drotrecogin alfa limits how much thrombin (one of the factors involved in blood clotting) is produced, and also reduces the inflammation caused by the infection. By using Xigris during sepsis, the risk of blood clots forming and damaging the organs is reduced.
Xigris has been studied in three studies in severe sepsis:
- in the PROWESS study, Xigris was compared with placebo (dummy treatment) in 1,690 patients;
- in the ENHANCE study, over 2,000 patients received Xigris;
- in the ADDRESS study, Xigris was compared with placebo in almost 3,000 patients who were at a lower risk of death than in the first two studies. All the studies looked at the number of patients who had died after 28 days.
Fewer patients treated with Xigris had died at 28 days than patients treated with placebo. The effect of Xigris was more marked when it was given within 24 hours of the start of organ failure, and in patients who had more than one organ failing.
As with other anticoagulants, the most common side effect with Xigris is bleeding. For the full list of all side effects reported with Xigris, see the Package Leaflet.
Xigris should not be used in people who may be hypersensitive (allergic) to drotrecogin alfa (activated), any of the other ingredients or bovine thrombin (a cow protein). It must not be used in patients below 18 years of age, in patients who have long-term liver disease, a brain tumour or pressure on the brain, in patients also receiving high-dose heparin (another medicine used to prevent blood clots) or in patients who currently have internal bleeding or are at risk of bleeding. For the full list of restrictions, see the Package Leaflet.
The Committee for Medicinal Products for Human Use (CHMP) decided that Xigris?s benefits are greater than its risks and recommended that it be given marketing authorisation.
Xigris has been authorised under ?Exceptional Circumstances?. This means that it has not been possible to obtain complete information about Xigris. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.