Xigris

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Drotrecogin alfa (activated)

Patient Information leaflet

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WHAT IS IN THIS LEAFLET 

This leaflet answers some common 
questions about Xigris. It does not 
contain all the available information.  It 
does not take the place of talking to 
your doctor or pharmacist. 
All medicines have risks and benefits.
.

Your doctor has weighed the risks of 
you being given Xigris against the 
benefits he/she expects it will have for 
you. 
IF YOU HAVE ANY CONCERNS ABOUT BEING 
GIVEN THIS MEDICINE, ASK YOUR DOCTOR 
OR HEALTH CARE PROFESSIONAL. 
KEEP THIS LEAFLET.  You may need to 
read it again. 

WHAT XIGRIS IS USED FOR

Xigris is used to treat severe sepsis in 
adult patients who have high risk of 
death. 
Xigris is drotrecogin alfa (activated) 
rhu, also known as human Activated  
Protein C. 
Xigris is produced by genetic 
engineering from a human cell line 
derived from human embryonic kidney 
cells. 
Xigris is very similar to a protein that 
occurs naturally in your blood.  This 
protein helps to control blood clotting 
and inflammation.  When your body 
has a severe infection, clots can form in 
your blood.  These can block the blood 
supply to important parts of your body 
such as the kidneys and lungs.  This 
causes an illness called severe sepsis 
which can make you very ill.  Some 
people will die from this illness.  Xigris 
helps your body to get rid of the clots 
and also reduces the inflammation 
caused by the infection. 
ASK YOUR DOCTOR IF YOU HAVE ANY 
QUESTIONS ABOUT WHY THIS MEDICINE 
HAS BEEN PRESCRIBED FOR YOU.  YOUR 
DOCTOR MAY HAVE PRESCRIBED IT FOR 
ANOTHER REASON. 

BEFORE YOU ARE GIVEN 
XIGRIS

_WHEN YOU MUST NOT HAVE IT _
_ _
DO NOT HAVE XIGRIS IF YOU HAVE AN 
ALLERGY TO: 

•  any medicine containing 
drotrecogin alfa (activated) rhu 
•  any of the ingredients listed at the 
end of this leaflet. 

Some of the symptoms of an allergic 
reaction may include shortness of 

Summary of Product characteristics

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XIGRIS
®

Drotrecogin alfa (activated) rhu 

NAME OF THE MEDICINE 

Xigris
®
 [drotrecogin alfa (activated) rhu] 
Xigris [drotrecogin alfa (activated) rhu] is human Activated
Protein C produced by 
recombinant DNA technology. 

DESCRIPTION 

Xigris is a recombinant version of the endogenous human
activated protein C and is 
produced by genetic
engineering from an established human cell line (HEK-293).  
The HEK-293 cell line was derived from primary, human
embryonic kidney cells.  
The   HEK-293 cells used for the production
of Xigris were originally obtained from 
the American Type Culture Collection (ATCC). 
Xigris is supplied as a sterile, lyophilised, white to practically white powder for 
intravenous infusion. Each vial of Xigris contains 5
mg of drotrecogin alfa (activated). 
Other ingredients include sucrose, sodium chloride,
citrate (buffer system composed 
of citric acid, sodium citrate, hydrochloric acid and
sodium hydroxide), hydrochloric 
acid, if necessary, and sodium hydroxide, if necessary. Each
vial contains an excess of 
Xigris to facilitate withdrawal of the labelled amount
of drug product. 
PHARMACOLOGY 

PHARMACODYNAMIC EFFECTS 
Activated Protein C has antithrombotic,
profibrinolytic and anti-inflammatory 
properties. Xigris has similar properties to
those of endogenous human Activated 
Protein C. 

In placebo-controlled clinical
trials in patients with severe sepsis, Xigris exerted an 
antithrombotic effect by limiting thrombin generation and improved
sepsis-associated 
coagulopathy, as shown by a more rapid improvement in
markers of coagulation and 
fibrinolysis.  Xigris caused a more rapid decline in
thrombotic markers such as D-
dimer, prothrombin F1.2 and thrombin-antithrombin levels and
a more rapid increase 
in Protein C and antithrombin levels.  Xigris