Dupixent

Kraj: Unia Europejska

Język: angielski

Źródło: EMA (European Medicines Agency)

Składnik aktywny:

dupilumab

Dostępny od:

Sanofi Winthrop Industrie

Kod ATC:

D11AH05

INN (International Nazwa):

dupilumab

Grupa terapeutyczna:

Agents for dermatitis, excluding corticosteroids

Dziedzina terapeutyczna:

Dermatitis, Atopic; Prurigo; Esophageal Diseases; Asthma; Sinusitis

Wskazania:

Atopic dermatitisAdults and adolescentsDupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.Children 6 months to 11 years of ageDupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy.AsthmaAdults and adolescentsDupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), see section 5.1, who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.Children 6 to 11 years of ageDupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.Chronic rhinosinusitis with nasal polyposis (CRSwNP)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.Prurigo Nodularis (PN)Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.Eosinophilic esophagitis (EoE)Dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Podsumowanie produktu:

Revision: 30

Status autoryzacji:

Authorised

Data autoryzacji:

2017-09-26

Ulotka dla pacjenta

136
B. PACKAGE LEAFLET
137
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUPIXENT 300 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
dupilumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dupixent is and what it is used for
2.
What you need to know before you use Dupixent
3.
How to use Dupixent
4.
Possible side effects
5.
How to store Dupixent
6.
Contents of the pack and other information
1.
WHAT DUPIXENT IS AND WHAT IT IS USED FOR
WHAT DUPIXENT IS
Dupixent contains the active substance dupilumab.
Dupilumab is a monoclonal antibody (a type of specialised protein)
that blocks the action of proteins
called interleukins (IL)-4 and IL-13. Both play a major role in
causing the signs and symptoms of
atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis
(CRSwNP), prurigo nodularis
(PN) and eosinophilic esophagitis (EoE).
WHAT DUPIXENT IS USED FOR
Dupixent is used to treat adults and adolescents 12 years and older
with moderate-to-severe atopic
dermatitis, also known as atopic eczema. Dupixent is also used to
treat children 6 months to 11 years
old with severe atopic dermatitis. Dupixent may be used with eczema
medicines that you apply to the
skin or it may be used on its own.
Dupixent is also used with other asthma medicines for the maintenance
treatment of severe asthma in
adults, adolescents, and children aged 6 years and older whose asthma
is not controlled with their
current asthma medicines (e.g. corticosteroids).
Dupixent is also used with other medicines for the mai

Charakterystyka produktu

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Dupixent 300 mg solution for injection in pre-filled syringe
Dupixent 300 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dupilumab 300 mg solution for injection in pre-filled syringe
Each single-use pre-filled syringe contains 300 mg of dupilumab in 2
mL solution (150 mg/mL).
Dupilumab 300 mg solution for injection in pre-filled pen
Each single-use pre-filled pen contains 300 mg of dupilumab in 2 mL
solution (150 mg/mL).
Dupilumab is a fully human monoclonal antibody produced in Chinese
Hamster Ovary (CHO) cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
Clear to slightly opalescent, colourless to pale yellow sterile
solution, which is free from visible
particulates, with a pH of approximately 5.9.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atopic dermatitis
_Adults and adolescents_
Dupixent is indicated for the treatment of moderate-to-severe atopic
dermatitis in adults and
adolescents 12 years and older who are candidates for systemic
therapy.
_Children 6 months to 11 years of age _
Dupixent is indicated for the treatment of severe atopic dermatitis in
children 6 months to 11 years old
who are candidates for systemic therapy.
Asthma
_Adults and adolescents _
Dupixent is indicated in adults and adolescents 12 years and older as
add-on maintenance treatment for
severe asthma with type 2 inflammation characterised by raised blood
eosinophils and/or raised
fraction of exhaled nitric oxide (FeNO), see section 5.1, who are
inadequately controlled with high
dose inhaled corticosteroids (ICS) plus another medicinal product for
maintenance treatment.
_Children 6 to 11 years of age _
Dupixent is indicated in children 6 to 11 years old as add-on
maintenance treatment for severe asthma
with type 2 inflammation characterised by raised blood eosinophils
and/or raised fraction of exhaled
nitric oxide (Fe