ENSPRYNG 120 mg1ml solution for injection in pre-filled syringe

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Satralizumab

Boleh didapati daripada:

ROCHE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Satralizumab

Unit dalam pakej:

1 Pre-Filled Syringes

Dikeluarkan oleh:

F. HOFFMANN-LA ROCHE LTD

Risalah maklumat

_Consumer_
_ _
_Medication_
_ _
_Information_
_ _
_Leaflet_
_ _
_(RiMUP)_
ENSPRYNG
®/™ 120MG/1ML
SOLUTION FOR INJECTION IN A PRE-FILLE D SYRINGE
)
SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
SATRALIZUMAB
WHAT IS IN THIS LEAFLET
1.
What Enspryng is used for
2.
How Enspryng works
3.
Before you use Enspryng
4.
How to use Enspryng
5.
While you are using Enspryng
6.
Side effects
7.
Storage and Disposal of Enspryng
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ENSPRYNG IS USED FOR
Enspryng
is
a
medicine
for
treating
neuromyelitis optica spectrum disorders
(NMOSD) in adults and young people
from 12 years of age.
NMOSD
is
a
disease
of
the
central
nervous system that mainly affects the
optic nerves and spinal cord.
It is caused by the immune system (the
body’s defences) working incorrectly and
attacking nerves in the body.
•
The damage to the optic nerves causes
swelling, leading to pain and loss of
sight.
•
The damage to the spinal cord causes
weakness or loss of movement in the
legs
or
arms,
loss
of
feeling,
and
problems
with
bladder
and
bowel
function.
HOW ENSPRYNG WORKS
Enspryng blocks the action of a protein
called
interleukin-6
(IL-6),
which
is
involved
in
the
processes
that
lead
to
damage
and
swelling
in
the
nervous
system. By blocking its effects, Enspryng
reduces the risk of a relapse or attack of
NMOSD.
BEFORE YOU USE ENSPRYNG
_When you must not use it_
_ _
Do not use Enspryng:

if you are allergic to satralizumab or
any of the other ingredients of this
medicine (listed in ingredient).

If the below applies to you or you are
not sure, do not use Enspryng and
talk to your doctor, pharmacist or
nurse.

The package is torn or shows signs of
tampering.

The expiry date (EXP) printed on the
pack has passed.
_Before you start to use it_
Talk to your doctor immediately if you
experience any allergic reaction
Talk to your doctor, pharmacist or
healthcare professional before using
Enspryng if any of the following applies
to you (or if you are not

Ciri produk

PACK INSERT FOR MALAYSIA
ENSPRYNG
®/™ 120MG/1ML
Solution for injection in a pre-filled syringe
Satralizumab
________________________________________________________________
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Enspryng is a recombinant humanized immunoglobulin G2 (IgG2)
monoclonal antibody
against the human interleukin-6 receptor (IL-6R), produced in Chinese
hamster ovary cells
by recombinant DNA technology (including a pH-dependent binding
technology).
ATC code: L04AC19
1.2
TYPE OF DOSAGE FORM
Ready-to-use sterile solution for subcutaneous (SC) injection in a
single-dose, prefilled
syringe (PFS) with needle safety device (NSD).
1.3
ROUTE OF ADMINISTRATION
Subcutaneous (SC) injection
1.4
STERILE / RADIOACTIVE STATEMENT
Sterile product
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _satralizumab
_Excipients: _L_-_Histidine, L-Aspartic acid, L-Arginine, Poloxamer
188, Water for injection
Enspryng solution for SC injection is a colorless to slightly yellow
liquid supplied in a PFS
filled with 1 mL of solution. Each PFS contains 120 mg of
satralizumab.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
Enspryng
is
indicated
as
a
monotherapy
or
in
combination
with
immunosuppressive
therapy
(IST)
for
the
treatment
of
neuromyelitis
optica
spectrum disorder (NMOSD) in adult and adolescent patients from 12
years of age
who
are
anti-aquaporin-4
IgG
(AQP4-IgG)
seropositive
(see
section
3.1
pharmacodynamics).
2.2
DOSAGE AND ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the
treatment of neuromyelitis optica spectrum disorder (NMOSD.
POSOLOGY
Enspryng can be used as a monotherapy or in combination with oral
corticosteroids (OCs),
azathioprine (AZA) or mycophenolate mofetil (MMF) (see section 3.1
Pharmacodynamics).
The posology in adolescent patients
≥
12 years of age with body weight
≥
40 kg and
adult patients is the same.
LOADING DOSES
The recommended loading dose is 120 mg subcutaneous (SC) injection
every two weeks
for the