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xigris-cmi-v1-15apr08
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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
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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
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