Ilaris

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

Canakinumab

Tilgængelig fra:

Novartis Pharmaceuticals Australia Pty Ltd

Klasse:

Medicine Registered

Indlægsseddel

ILARIS
®

_canakinumab_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ilaris.
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 taking Ilaris against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ILARIS IS USED FOR
Ilaris is used to treat certain auto-
inflammatory diseases which are
collectively known as Cryopyrin-
Associated Periodic Syndromes.
These include:
•
Familial Cold Auto-inflammatory
Syndrome (also called Familial
Cold Urticaria)
•
Muckle-Wells Syndrome
•
Neonatal-Onset Multisystem
Inflammatory Disease (also called
Chronic Infantile Neurological,
Cutaneous, Articular Syndrome)
With these conditions, the body
produces excessive amounts of a
chemical messenger called
interleukin-1 beta. This may lead to
symptoms such as fever, headache,
fatigue, skin rash, painful joints and
muscles. In some people, more
severe outcomes such as hearing
impairment are observed.
Ilaris belongs to a group of medicines
called interleukin-1 inhibitors. The
active substance in Ilaris is
canakinumab.
It binds to interleukin-1 beta,
blocking its activity. This leads to an
improvement in symptoms.
Ilaris is injected every 8 weeks as a
single dose under the skin (also
called subcutaneous injection).
ASK YOUR D

Produktets egenskaber

1 

ILARIS


CANAKINUMAB 

NAME OF THE MEDICINE 
Active ingredient:  
Canakinumab 
Chemical name:  
Immunoglobulin G1, anti-(human interleukin-1beta (IL-
1β))  human 
monoclonal ACZ885; (1Glu>Glp)-
γ1  heavy  chain  (221-214’)-
disulfide with kappa light chain, dimer (227-227”:230-230”)-
bisdisulfide 
CAS number:   
402710-25-
2 (variable heavy γ1 chain) 

402710-27-
4 (variable light κ chain) 
Molecular weight:  
Approximately 145.157kDa 
Structure:  
Canakinumab comprises  two 447(or 448)-residue heavy chains and 
two 214-residue light chains. 

DESCRIPTION 
Canakinumab is a high-affinity fully human anti-human-IL-
1β  monoclonal  antibody  that 
belongs to the IgG1/κ isotype subclass. It is expressed in
a murine SP2/0 cell line. 

Ilaris is a sterile, white, lyophilised powder that
is reconstituted with water for injections and 
administered as a subcutaneous (SC) injection. A reconstituted
single-use vial delivers 150 
mg canakinumab per 1 mL. 

Excipients:  Sucrose, histidine,
histidine hydrochloride  monohydrate, polysorbate 80, dilute 
hydrochloric acid. 

PHARMACOLOGY 
PHARMACODYNAMICS 
Canakinumab is a fully human monoclonal anti-human
interleukin-1beta (IL-1beta) antibody 
of the IgG1/kappa isotype. Canakinumab binds with
high affinity to human IL-1beta and 
neutralises the biological
activity of  human IL-1beta by blocking its interaction with IL-1 
receptors, thereby preventing IL-1beta-induced gene activation
and the production of 
inflammatory mediators such as interleukin-6 or cyclooxygenase-2.
Canakinumab is therefore 
suited to treat diseases and pathologies characterised
by local or systemic overproduction of 
IL-1beta. 

Excess production
of IL-1beta in inflammatory diseases leads to local
or systemic 
inflammation, increased production
of the inflammatory markers C-react