Gilenya

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Fingolimod hydrochloride 0.56mg;  ;  ;  

Available from:

Novartis New Zealand Ltd

INN (International Name):

Fingolimod hydrochloride 0.56 mg

Dosage:

0.5 mg

Pharmaceutical form:

Capsule

Composition:

Active: Fingolimod hydrochloride 0.56mg       Excipient: Capsugel white 4998 Gelatin Ink Iron oxide yellow Magnesium stearate Mannitol Titanium dioxide

Units in package:

Blister pack, PVC/PVDC/Al, 7 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Novartis International Pharmaceutical Ltd Ireland

Therapeutic indications:

GILENYA is indicated as a disease modifying therapy for the treatment of patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 7 capsules - 18 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, PVC/PVDC/Al - 28 capsules - 18 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, PVC/PVDC/Al - 84 capsules - 18 months from date of manufacture stored at or below 30°C protect from moisture

Authorization date:

2010-09-09

Patient Information leaflet

GILENYA
®
Page 1 of 7
GILENYA

_Fingolimod hydrochloride _
CONSUMER MEDICINE INFORMATION
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.MEDSAFE.GOVT.NZ
.
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 medicine used to treat
relapsing multiple sclerosis (MS).
GILENYA
does not cure MS, but it
helps to reduce the number of
relapses that occur and to slow the
build-up of physical problems due to
MS (disability progression).
GILENYA 0.5 mg hard capsules
contain the active substance
fingolimod, which belongs to a
group of medicine known as
sphingosine-1-phosphate (S1-P)
receptor modulators.
MULTIPLE SCLEROSIS (MS)
is a long-
term condition that affects the central
nervous system (CNS), particularly
how the brain and spinal cord work.
In MS inflammation destroys the
protective sheath (called myelin)
around the nerves in the CNS and
stops the nerves from working
properly. This process is called
demyelination.
The exact cause of MS is unknown.
An abnormal response by the body’s
immune system is thought to play an
important part in the process which
damages the CNS.
People with MS experience repeated
bouts of nervous system symptoms
that reflect inflammation

Summary of Product characteristics

New Zealand Data sheet
Page 1 of 31
1 PRODUCT NAME
GILENYA® 0.5 mg capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.5 mg fingolimod (as hydrochloride).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
GILENYA 0.5 mg : white to almost white powder in white opaque body and
bright yellow opaque cap
gelatin capsules, size 3, radial imprint with black ink “FTY 0.5
mg” on cap and two radial bands
imprinted on body with yellow ink.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
GILENYA is indicated as a disease modifying therapy for the treatment
of patients with relapsing
multiple sclerosis to reduce the frequency of relapses and to delay
the progression of disability.
4.2
Dose and method of administration
Posology
The recommended dose of GILENYA is one 0.5 mg capsule taken orally
once daily, which can be taken
with or without food. If a dose is missed treatment should be
continued with the next dose as planned.
On initiation of GILENYA treatment, after the first dose, it is
recommended that all patients be
observed, with hourly pulse and blood pressure measurement, for a
period of 6 hours for signs and
symptoms of bradycardia. All patients should have an electrocardiogram
performed prior to dosing
and at the end of the 6-hour monitoring period (see section 4.4
special warnings and precautions,
Bradyarrhythmia).
For recommendations related to switching patients from other disease
modifying therapies to
GILENYA
(see
section
4.4
special
warnings
and
precautions:
Prior
treatment
with
immunosuppressants).
Special populations
_Children _
GILENYA
is
not
indicated
for
use
in
paediatric
patients.
(See
section
5
PHARMACOLOGICAL
PROPERTIES).
_The Elderly (≥ 65 years) _
GILENYA should be used with caution in patients aged 65 years and over
(see section 5 PHARMACOLOGICAL PROPERTIES).
_Patients with Renal Impairment _
No
GILENYA
dose
adjustments
are
needed
in
patients
with
renal
impairment
(see
section
5
PHARMACOLOGICAL PROPERTIES).
New Zealand Data sheet
Page 2 of 31
_Pa