Kiendra 2mg film-coated tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Siponimod fumaric acid

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Siponimod fumaric acid

Unit dalam pakej:

28 Tablets

Dikeluarkan oleh:

NOVARTIS PHARMA STEIN AG

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
KIENDRA
™
FILM-COATED TABLET
_ _
Siponimod (0.25mg and 2mg)
1
WHAT IS IN THIS LEAFLET
1. What Kiendra is used for
2. How it works
3. Before you use Kiendra
4. How to use Kiendra
5. While you are using it
6. Side effects
7. Storage and Disposal of product
8. Product description
9. Manufacturer
10. Product registration holder
11. Date of revision
12. Serial number
WHAT KIENDRA IS USED FOR
Kiendra is used for the treatment of
adult patients with secondary
progressive multiple sclerosis
(SPMS) with active disease.
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, the immune system (the
body’s defense system) works
incorrectly: 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
attacks of nervous system symptoms
that reflect inflammation within the
CNS. These attacks are typically
called relapses or flare ups.
Symptoms vary from patient to
patient but typically involve problems
with walking or balance, weakness,
numbness, vision problems (double
vision and blurring), and poor
coordination and bladder problems.
The symptoms of a relapse may
disappear completely when the
relapse is over but some problems
may remain. This form of disease is
called relapsing multiple sclerosis
(RMS).
Eventually, in most of the cases,
people with relapsing MS find that
their symptoms and the severity of
their symptoms gradually increase
between relapses, indicating
transition to the secondary
progressive form of MS (SPMS).
HOW KIENDRA WORKS
Kiendra belongs to a group of
medicines called sphingosine-1-
phosphate (S1P) receptor modulators.
Siponimod binds selectively on tw

Ciri produk

Novartis
Confidential
Page 1
Malaysia Package Leaflet
06-Aug-2020
Kiendra
1
1.
NAME OF THE MEDICINAL PRODUCT
Kiendra 0.25 mg film-coated tablets
Kiendra 2 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kiendra 0.25 mg film-coated tablets
Each film-coated tablet contains siponimod fumaric acid equivalent to
0.25 mg siponimod.
_Excipient with known effect _
Each tablet contains 59.1 mg lactose (as monohydrate) and 0.092 mg
soya lecithin.
Kiendra 2 mg film-coated tablets
Each film-coated tablet contains siponimod fumaric acid equivalent to
2 mg siponimod.
_Excipient with known effect _
Each tablet contains 57.3 mg lactose (as monohydrate) and 0.092 mg
soya lecithin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet
Kiendra 0.25 mg film-coated tablets
Pale red, round, unscored, biconvex, bevelled-edged film-coated tablet
of approximately 6.1 mm
diameter with company logo on one side and “
T
” on the other side.
Kiendra 2 mg film-coated tablets
Pale yellow, round, unscored, biconvex, bevelled-edged film-coated
tablet of approximately 6.1 mm
diameter with company logo on one side and “
II
” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kiendra is indicated for the treatment of adult patients with
secondary progressive multiple sclerosis
(SPMS) with active disease evidenced by relapses or imaging features
of inflammatory activity (see
section 5.1).
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with siponimod should be initiated and supervised by a
physician experienced in the
management of multiple sclerosis.
Novartis
Confidential
Page 2
Malaysia Package Leaflet
06-Aug-2020
Kiendra
2
Before initiation of treatment, patients must be genotyped for CYP2C9
to determine their CYP2C9
metaboliser status (see sections 4.4, 4.5 and 5.2).
In patients with a CYP2C9*3*3 genotype, siponimod should not be used
(see sections 4.3, 4.4 and
5.2).
In patients with a CYP2C9*2*3 or *1*3 genotype, the recommended
maintenance dose is 1 mg