Dupixent 200mg Solution for Injection in Pre-Filled Syringe

Country: Malaysia

Language: English

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

Active ingredient:

DUPILUMAB

Available from:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

DUPILUMAB

Units in package:

2 Pre-Filled Syringes

Manufactured by:

Sanofi Winthrop Industrie

Patient Information leaflet

Consumer Medication Information Leaflet (RiMUP)
DUPIXENT
Dupilumab 200 mg/1.14 mL
Dupilumab 300 mg/2 mL
1
What is in this leaflet
1.
What DUPIXENT is used for
2.
How DUPIXENT works
3.
Before you use DUPIXENT
4.
How to use DUPIXENT
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of DUPIXENT
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
What DUPIXENT is used for
DUPIXENT (dupilumab) is a
prescription medicine used:

to treat adults and children aged 6
months and older with moderate-to-
severe atopic dermatitis (eczema)
that is not well controlled with
prescription therapies used on the
skin (topical), or who cannot use
topical therapies. DUPIXENT can
be used with or without topical
corticosteroids. It is not known if
DUPIXENT is safe and effective in
children with atopic dermatitis
under 6 months of age.

with other asthma medicines for the
maintenance treatment of severe
asthma in adults and children 12
years of age and older whose asthma
is not controlled with their current
asthma medicines. DUPIXENT
helps prevent severe asthma attacks
(exacerbations) and can improve
your breathing. DUPIXENT may
also help reduce the amount of oral
corticosteroids you need while
preventing severe asthma attacks
and improving your breathing.
DUPIXENT is not used to treat
sudden breathing problems.

with other medicines for the
maintenance treatment of chronic
rhinosinusitis with nasal polyposis
(CRSwNP) in adults whose disease is
not controlled.
It is not known if DUPIXENT is safe
and effective in children with chronic
rhinosinusitis with nasal polyposis
under 18 years of age.
How DUPIXENT works
Dupilumab is a monoclonal antibody (a
type of specialised protein) that blocks
the action of proteins called IL-4 and IL-
13. Both play a major role in causing the
signs and symptoms of atopic dermatitis,
asthma and chronic rhinosinusitis with
nasal polyposis.
Before you use DUPIXENT
- When you must not use it
Do not use DUPIXENT if you are
allergic to dupilumab or to

Summary of Product characteristics

MY/DUP/1023/US PI 2022 06
Internal
DUPIXENT (DUPILUMAB) 300 MG SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
DUPIXENT (DUPILUMAB) 200 MG SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
DUPIXENT is indicated for the following diseases:
1.1 ATOPIC DERMATITIS
DUPIXENT is indicated for the treatment of adult and pediatric
patients aged 6 months and older
with moderate-to-severe atopic dermatitis whose disease is not
adequately controlled with topical
prescription therapies or when those therapies are not advisable.
DUPIXENT can be used with or
without topical corticosteroids.
1.2 ASTHMA
DUPIXENT is indicated in adults and adolescents 12 years and older as
an add on maintenance
treatment for severe asthma with type 2 inflammation characterized by
raised blood eosinophils
and/or raised fraction of exhaled nitric oxide (FeNO). DUPIXENT is
indicated as maintenance
therapy for oral corticosteroid-dependent asthma.
1.3 CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS
DUPIXENT is indicated as an add-on therapy with intranasal
corticosteroids for the treatment of
adults with severe CRSwNP for whom therapy with systemic
corticosteroids and/or surgery do not
provide adequate disease control.
2
DOSAGE AND ADMINISTRATION
2.1 IMPORTANT ADMINISTRATION INSTRUCTIONS
DUPIXENT is administered by subcutaneous injection.
DUPIXENT is intended for use under the guidance of a healthcare
provider. Provide proper training
to patients and/or caregivers on the preparation and administration of
DUPIXENT prior to use
according to the “Instructions for Use”
Use of Pre-filled Syringe
The DUPIXENT pre-filled syringe is for use in adult and pediatric
patients aged 6 months and older.
A caregiver or patient 12 years of age and older may inject DUPIXENT
using the pre-filled syringe.
In pediatric patients 12 to 17 years of age, administer DUPIXENT under
the supervision of an adult.
In pediatric patients 6 months to 11 years of age, administer DUPIXENT
pre-filled syringe by a
caregiver.
MY/DUP/1023/US PI 2