Xolair

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

Omalizumab

Dostępny od:

Novartis Pharmaceuticals Australia Pty Ltd

Klasa:

Medicine Registered

Ulotka dla pacjenta

XOLAIR
®

_Omalizumab(rch)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Xolair.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Xolair against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT XOLAIR IS USED
FOR
Xolair is used to prevent or relieve
the symptoms of allergic asthma in
people who are already using
preventer puffers containing steroids.
Asthma is a disease where the lining
of the lungs becomes inflamed (red
and swollen), making it difficult to
breathe. This may be due to a
reaction to house dust mites, smoke
or other irritants.
Xolair contains omalizumab, a
monoclonal antibody produced by
recombinant DNA technology. It
works by blocking a substance
produced by the body called
immunoglobulin E (or IgE). IgE is
involved in causing symptoms of
asthma. Your doctor will measure the
amount of IgE in your blood before
starting your treatment with Xolair.
This medicine can be used in adults
and in children aged 12 years or over.
Elderly patients are given the same
dosage as younger adults.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY XOLAIR HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
Xolair is only available with a
doctor's prescription. It is not

Charakterystyka produktu

 
Page 1 of 15 
XOLAIR


OMALIZUMAB (RCH) 
NAME OF THE MEDICINE 
The active ingredient of Xolair is omalizumab.  

CAS NO.:  

0242138-07-4 

DESCRIPTION 
Omalizumab is a recombinant DNA-derived humanised monoclonal
antibody produced in 
Chinese hamster ovary cells that selectively binds to human
immunoglobulin E (IgE).   

Xolair_ _is a sterile, white, preservative-free lyophilised powder
that is reconstituted with water 
for injections and administered as a subcutaneous (SC)
injection.  

One vial of Xolair 150 mg contains 150 mg of omalizumab. A
reconstituted single-use vial 
delivers 150 mg omalizumab per 1.2 mL (125 mg/mL).  

Excipients:  
Xolair
vial: sucrose, L-histidine, L-histidine hydrochloride monohydrate,
polysorbate 20. 
Solvent ampoule: water for injections 
PHARMACOLOGY 
PHARMACODYNAMICS 
Omalizumab is a recombinant DNA-derived humanised monoclonal
antibody that selectively 
binds to human immunoglobulin E (IgE).  The antibody is an IgG
1
 kappa that contains human 
framework regions with the complementary-determining regions of
a humanised murine 
antibody that binds to IgE. 

The allergic cascade is initiated when IgE bound to high
affinity Fc

RI receptors on the 
surface of mast cells and basophils is crosslinked by allergen.
 This results in the 
degranulation of these effector cells and the release of
histamines, leukotrienes, cytokines and 
other mediators.  These mediators are causally linked to
the pathophysiology of asthma, 
including airway oedema, smooth muscle contraction and
altered cellular activity associated 
with the inflammatory process.  They also contribute to
the signs and symptoms of allergic  
asthma such as bronchoconstriction, mucous production, wheezing,
dyspnoea and chest 
tightness. 

Omalizumab binds to IgE at the same site as the high-affinity FC

RI receptor, thereby 
reducing the amount of free IgE