Nucala 100mgml Solution for Injection in pre-filled syringe (Safety Syringe)

Country: Malaysia

Language: English

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

Active ingredient:

MEPOLIZUMAB

Available from:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (International Name):

MEPOLIZUMAB

Units in package:

1 Pre-filled syringe (safety syringe) per carton Units

Manufactured by:

Glaxo Operations UK Ltd (Trading as Glaxo Wellcome Operations)

Patient Information leaflet

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
NUCALA 100MG/ML SOLUTION FOR INJECTION IN
PRE-FILLED SYRINGE (SAFETY SYRINGE)_ _
Mepolizumab 100mg/ml
1
WHAT IS IN THIS LEAFLET
1.
What NUCALA is used for
2.
How NUCALA works
3.
Before you use NUCALA
4.
How to use NUCALA
5.
While you are using NUCALA
6.
Side effects
7.
Storage and disposal of NUCALA
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT NUCALA IS USED FOR
NUCALA contains the active substance
MEPOLIZUMAB
, a
_monoclonal antibody_
, a
type of protein designed to recognize a
specific target substance in the body. It is
used to treat severe eosinophilic asthma in
patients 12 years and older.
HOW NUCALA WORKS
Mepolizumab,
the
active
substance
in
NUCALA,
blocks
a
protein
called
_interleukin-5_
. By blocking the action of this
protein,
it
limits
the
production
of
eosinophils
from
the
bone
marrow
and
lowers the number of eosinophils in the
bloodstream and the lungs.
SEVERE EOSINOPHILIC ASTHMA
Some people with severe asthma have too
many
_eosinophils_
(a type of white blood
cell) in the blood and lungs.
This
condition
is
called
_eosinophilic _
_asthma_
– the type of asthma NUCALA can
treat.
NUCALA
can
reduce
your
number
of
asthma attacks, if you or your child are
already using medicines such as high dose
inhalers,
but
your
asthma
is
not
well
controlled by these medicines.
If you are taking medicines called
_oral _
_corticosteroids_
, NUCALA can also help
reduce the daily dose you need to control
your asthma.
_ _
BEFORE YOU USE NUCALA
_When you must not use it _
_ _
If you are allergic to mepolizumab or any
other ingredients of NUCALA
_Before you start to use it _
_ _
Before
you
use
NUCALA
your
doctor
needs to know:
•
Medicines
of
this
type
(monoclonal
antibodies)
can
cause
severe
allergic
reactions
when
injected
into
the
body.
Check with your doctor if you
think this may apply to you.
•
NUCALA
may
weaken
your
resistance to infections caused by
parasites. If you have a parasitic
infection,
it
should
be

Summary of Product characteristics

CONFIDENTIAL
[GSK logo]
NUCALA
MEPOLIZUMAB
QUALITATIVE AND QUANTITATIVE COMPOSITION
A clear to opalescent, colourless to pale yellow to pale brown
solution in a single-use, pre-
filled pen or syringe.
Each pre-filled pen (auto-injector) or pre-filled syringe
(safety-syringe) delivers 100 mg
mepolizumab in 1 mL (100 mg/mL).
Mepolizumab is a humanised monoclonal antibody (IgG1, kappa), directed
against human
interleukin-5
(IL-5)
produced
in
Chinese
hamster
ovary
cells
by
recombinant
DNA
technology.
PHARMACEUTICAL FORM:
Solution for injection in a pre-filled pen (auto-injector)
Solution for injection in a pre-filled syringe (safety syringe)
CLINICAL PARTICULARS
I
NDICATIONS
SEVERE EOSINOPHILIC ASTHMA
_NUCALA_
is indicated as an add-on maintenance treatment for patients aged 12
years old and
older with severe eosinophilic asthma who:
•
have at least two exacerbations in the preceding 12 months on current
standard of care
(high doses of inhaled corticosteroids plus additional maintenance
treatment) and/or
requirement for treatment with systemic corticosteroids, and
•
have a blood eosinophil count of ≥ 150 cells/µL (0.15 GI/L) at
initiation of treatment
with
_NUCALA _
OR ≥ 300 cells/µL (0.3 GI/L) in the past 12 months.
_NUCALA_
is not indicated for other eosinophilic conditions or for relief of
acute bronchospasm
or status asthmaticus (
_see Warnings and Precautions)_
.
DOSAGE AND ADMINISTRATION
_NUCALA_
should be prescribed by a specialist experienced in the diagnosis and
treatment of
severe eosinophilic asthma.
CONFIDENTIAL
_NUCALA_
should only be administered as a subcutaneous injection (see
_Special precautions _
_for disposal and other handling _
and
_ Instructions for Use_
).
_NUCALA_
may be self-administered by the patient or administered by a caregiver
if their
healthcare professional determines that it is appropriate and the
patient or caregiver are trained
in injection techniques.
POSOLOGY
SEVERE EOSINOPHILIC ASTHMA
ADULTS AND ADOLESCENTS (12 YEARS AND OLDER)
The recommended dose is 100 mg of
_NUCAL