Benlysta

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

belimumab

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

L04AA26

INN (International Name):

belimumab

Therapeutic group:

Immunosuppressants

Therapeutic area:

Lupus Erythematosus, Systemic

Therapeutic indications:

Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti dsDNA and low complement) despite standard therapy.Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.

Product summary:

Revision: 31

Authorization status:

Authorised

Authorization date:

2011-07-13

Patient Information leaflet

68
B. PACKAGE LEAFLET
69
PACKAGE LEAFLET: INFORMATION FOR THE USER
BENLYSTA 200 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
belimumab
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.
-
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. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Benlysta is and what it is used for
2.
What you need to know before you use Benlysta
3.
How Benlysta is used
4.
Possible side effects
5.
How to store Benlysta
6.
Contents of the pack and other information
Step-by-step instructions for using the pre-filled pen
1.
WHAT BENLYSTA IS AND WHAT IT IS USED FOR
BENLYSTA AS A SUBCUTANEOUS INJECTION IS A MEDICINE USED TO TREAT LUPUS
(systemic lupus erythematosus, SLE)
in adults (18 years of age and older) whose disease is still highly
active despite standard treatment. Benlysta is
also used in combination with other medicines to treat adults with
active lupus nephritis (lupus-related kidney
inflammation).
Lupus is a disease in which the immune system (the system that fights
infection) attacks your own cells and
tissues, causing inflammation and organ damage. It can affect almost
any organ in the body, and is thought to
involve a type of white blood cells called
_B cells_
.
Benlysta contains
BELIMUMAB
(
_a monoclonal antibody_
). It reduces the number of B cells in your blood by
blocking the action of BLyS, a protein that helps B cells to live
longer and is found in high levels in pe

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
Benlysta 200 mg solution for injection in pre-filled pen.
Benlysta 200 mg solution for injection in pre-filled syringe.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled pen
Each 1-mL pre-filled pen contains 200 mg of belimumab.
Pre-filled syringe
Each 1-mL pre-filled syringe contains 200 mg of belimumab.
Belimumab is a human, IgG1λ monoclonal antibody, produced in a
mammalian cell line (NS0) by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled pen (injection)
Solution for injection in pre-filled syringe (injection)
A clear to opalescent, colourless to pale yellow solution, with a pH
of 6.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Benlysta is indicated as add-on therapy in adult patients with active,
autoantibody-positive systemic lupus
erythematosus (SLE) with a high degree of disease activity (e.g.,
positive anti-dsDNA and low complement)
despite standard therapy (see section 5.1).
Benlysta is indicated in combination with background immunosuppressive
therapies for the treatment of
adult patients with active lupus nephritis (see sections 4.2 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Benlysta treatment should be initiated and supervised by a qualified
physician experienced in the diagnosis
and treatment of SLE. It is recommended that the first subcutaneous
injection of Benlysta should be under
the supervision of a healthcare professional in a setting that is
sufficiently qualified to manage
hypersensitivity reactions, if necessary. The healthcare professional
mu