Gilenya

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

Fingolimod hydrochloride

Disponibbli minn:

Novartis Pharmaceuticals Australia Pty Ltd

Klassi:

Medicine Registered

Fuljett ta 'informazzjoni

GILENYA
®

_Fingolimod hydrochloride_
CONSUMER MEDICINE INFORMATION (CMI)

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Gilenya.
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 this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT GILENYA IS USED
FOR
Gilenya is a new type of medicine
known as sphingosine 1-phosphate
(S1-P) receptor modulators. The
active substance of Gilenya is
fingolimod.
Gilenya can alter the way the body's
immune system works and is used to
treat relapsing remitting multiple
sclerosis (MS) and relapses in
patients with secondary progressive
multiple sclerosis.
Gilenya slows down the progression
of physical disability and decreases
the number of flare-ups (relapses) in
patients with some relapsing forms of
MS.
Gilenya helps to fight against attacks
of the immune system by affecting
the ability of some white blood cells
to move freely within the body and
by stopping the cells that cause
inflammation from reaching the
brain. This reduces nerve damage
caused by MS. Gilenya may also
have a direct and beneficial effect on
certain brain cells (neural cells)
involved in repairing or slowing
down the damage of MS.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT HOW GILENYA
WORKS OR WHY THIS MEDICINE HAS
BE

Karatteristiċi tal-prodott

1

GILENYA
®

FINGOLIMOD 

NAME OF THE MEDICINE 

The active ingredient of GILENYA is fingolimod. 

Chemical name:  
2-amino-2-(2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride 
Chemical structure: 

N
H
2
OH
OH
Cl
H
.

Molecular formula:   C
19
H
33
NO
2
 · HCl 
CAS number:  
162359-56-0

Molecular weight:  
343.93 

DESCRIPTION 

Fingolimod hydrochloride is a white to almost
white crystalline powder which is freely soluble 
in water. Fingolimod is a base with pKa of 7.82. Therefore,
it has high solubility at low pH and 
very low solubility at high pH (e.g. < 0.01
mg/mL at pH 6.8). Relevant distribution coefficients 
are 22.3 in n-Octanol/water and 1290 in
n-Octanol/hydrochloric acid 0.1N. 

Each GILENYA capsule contains 0.56 mg
fingolimod hydrochloride (equivalent to 0.5 mg 
fingolimod), mannitol, magnesium stearate, titanium dioxide and
gelatin. 

PHARMACOLOGY 

MECHANISM OF ACTION 
Fingolimod is a sphingosine 1-phosphate receptor modulator.
Fingolimod is metabolized by 
sphingosine kinase to the active metabolite fingolimod-phosphate.
Fingolimod-phosphate,  
binds at low nanomolar concentrations to
sphingosine 1-phosphate (S1P) receptors 1, 3, and 4 
located on lymphocytes, and readily crosses the blood brain
barrier to bind to S1P receptors 1, 
3, and 5 located on neural cells in the central nervous system. By
acting as a functional 
antagonist of S1P receptors on lymphocytes,
fingolimod-phosphate blocks the capacity of 
lymphocytes to egress from lymph nodes, causing a redistribution,
rather than depletion, of 
lymphocytes. This redistribution reduces the infiltration
of pathogenic lymphocyte cells into 
the central nervous system where they would be involved in
nerve inflammation and nervous 
tissue
damage. Animal studies and _in vitro_ experiments indicate that fingolimod
may also exert 
beneficial effects in