Bimzelx

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Bimekizumab

Available from:

UCB Pharma S.A.  

ATC code:

L04AC

INN (International Name):

bimekizumab

Therapeutic group:

Immunosuppressants

Therapeutic area:

Psoriasis

Therapeutic indications:

Plaque psoriasisBimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.Psoriatic arthritisBimzelx, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).Axial spondyloarthritisNon-radiographic axial spondyloarthritis (nr-axSpA)Bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)Bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.

Product summary:

Revision: 5

Authorization status:

Authorised

Authorization date:

2021-08-20

Patient Information leaflet

51
B. PACKAGE LEAFLET
52
PACKAGE LEAFLET: INFORMATION FOR THE USER
BIMZELX 160 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
bimekizumab
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 Bimzelx is and what it is used for
2.
What you need to know before you use Bimzelx
3.
How to use Bimzelx
4.
Possible side effects
5.
How to store Bimzelx
6.
Contents of the pack and other information
Instructions for use
1.
WHAT BIMZELX IS AND WHAT IT IS USED FOR
WHAT BIMZELX IS
Bimzelx contains the active substance bimekizumab.
WHAT BIMZELX IS USED FOR
Bimzelx is used to treat the following inflammatory diseases:
•
Plaque psoriasis
•
Psoriatic arthritis
•
Axial spondyloarthritis, including non-radiographic axial
spondyloarthritis and ankylosing
spondylitis (radiographic axial spondyloarthritis)
•
Hidradenitis suppurativa
Plaque psoriasis
Bimzelx is used in adults to treat a skin condition called plaque
psoriasis. Bimzelx reduces the
symptoms, including pain, itching, and scaling of the skin.
Psoriatic arthritis
Bimzelx is used to treat adults with psoriatic arthritis. Psoriatic
arthritis is a disease that causes
inflamed joints, often accompanied by plaque psoriasis. If you have
active psoriatic arthritis, you may
first be given other medicines. If these medicines do

Summary of Product characteristics

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
Bimzelx 160 mg solution for injection in pre-filled syringe
Bimzelx 160 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bimzelx 160 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 160 mg of bimekizumab in 1 mL.
Bimzelx 160 mg solution for injection in pre-filled pen
Each pre-filled pen contains 160 mg of bimekizumab in 1 mL.
Bimekizumab is a humanised IgG1monoclonal antibody produced in a
genetically engineered Chinese
hamster ovary (CHO) cell line by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
The solution is clear to slightly opalescent and, colourless to pale
brownish-yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PLAQUE PSORIASIS
Bimzelx is indicated for the treatment of moderate to severe plaque
psoriasis in adults who are
candidates for systemic therapy.
PSORIATIC ARTHRITIS
Bimzelx, alone or in combination with methotrexate, is indicated for
the treatment of active psoriatic
arthritis in adults who have had an inadequate response or who have
been intolerant to one or more
disease-modifying antirheumatic drugs (DMARDs).
AXIAL SPONDYLOARTHRITIS
_ _
_Non-radiographic axial spondyloarthritis (nr-axSpA) _
_ _
Bimzelx is indicated for the treatment of adults with active
non-radiographic axial spondyloarthritis
with objective signs of inflammation as indicated by elevated
C-reactive protein (CRP) and/or
magnetic resonance imaging (MRI) who have responded inadequately or
are intolerant to non-
steroidal anti-inflammatory drugs (NSAIDs).
_ _
3
_Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) _
_