Ebglyss

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Lebrikizumab

Διαθέσιμο από:

Almirall, S.A.

Φαρμακολογική κατηγορία (ATC):

D11AH

INN (Διεθνής Όνομα):

Lebrikizumab

Θεραπευτική ομάδα:

Other dermatological preparations

Θεραπευτική περιοχή:

Dermatitis, Atopic

Θεραπευτικές ενδείξεις:

Ebglyss is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy.

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2023-11-16

Φύλλο οδηγιών χρήσης

36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET: INFORMATION FOR THE USER
EBGLYSS 250 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
lebrikizumab
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Ebglyss is and what it is used for
2.
What you need to know before you use Ebglyss
3.
How to use Ebglyss
4.
Possible side effects
5.
How to store Ebglyss
6.
Contents of the pack and other information
Instructions for use
1.
WHAT EBGLYSS IS AND WHAT IT IS USED FOR
Ebglyss contains the active substance lebrikizumab.
Ebglyss is used to treat adults and adolescents 12 years and older
with a body weight of at least 40 kg
with moderate-to-severe atopic dermatitis, also known as atopic
eczema, who can be treated with
systemic treatments (a medicine given by mouth or injection).
Ebglyss may be used with eczema medicines that you apply to the skin
or it may be used on its own.
Lebrikizumab is a monoclonal antibody (a type of protein) that blocks
the action of another protein
called interleukin-13. Interleukin-13 plays a major role in causing
the symptoms of atopic dermatitis.
By blocking interleukin-13, Ebglyss can improve your atopic dermatitis
and reduce the related itching
and skin pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EBGLYSS
_ _
DO NOT USE EBGLYSS
-
if you are allergic t

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Ebglyss 250 mg solution for injection in pre-filled syringe
Ebglyss 250 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ebglyss 250 mg solution for injection in pre-filled syringe
Each single-use pre-filled syringe contains 250 mg of lebrikizumab in
2 mL solution (125 mg/mL).
Ebglyss 250 mg solution for injection in pre-filled pen
Each single-use pre-filled pen contains 250 mg of lebrikizumab in 2 mL
solution (125 mg/mL).
Lebrikizumab is 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 opalescent, colourless to slightly yellow to slightly brown
solution, free of visible particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Ebglyss is indicated for the treatment of moderate-to-severe atopic
dermatitis in adults and adolescents
12 years and older with a body weight of at least 40 kg who are
candidates for systemic therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by healthcare professionals experienced
in the diagnosis and treatment
of atopic dermatitis.
Posology
The recommended dose of lebrikizumab is 500 mg (two 250 mg injections)
at both week 0 and
week 2, followed by 250 mg administered subcutaneously every other
week up to week 16.
Consideration should be given to discontinuing treatment in patients
who have shown no clinical
response after 16 weeks of treatment. Some patients with initial
partial response may further improve
with continued treatment every other week up to week 24.
Once clinical response is achieved, the recommended maintenance dose
of lebr