Benlysta 400mg powder for concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Belimumab

Available from:

GlaxoSmithKline UK Ltd

ATC code:

L04AA26

INN (International Name):

Belimumab

Dosage:

400mg

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010300; GTIN: 5000123113866

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
BENLYSTA 120 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
BENLYSTA 400 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
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.
-
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 are given Benlysta
3.
How Benlysta is used
4.
Possible side effects
5
How to store Benlysta
6.
Contents of the pack and other information
1.
WHAT BENLYSTA IS AND WHAT IT IS USED FOR
BENLYSTA 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.
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 people
with lupus.
You will be given Benlysta as well as your usual treatment for lupus.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN BENLYSTA
_ _
DO NOT RECEIVE BENLYSTA:
•
if you are
ALLERGIC
to belimumab or any of the other ingredients of this medicine
_(listed in section 6)._

CHECK WITH YOUR DOCTOR
if th

Summary of Product characteristics

OBJECT 1
BENLYSTA 120 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 27-Nov-2017 |
GlaxoSmithKline UK
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 120 mg powder for concentrate for solution for infusion.
Benlysta 400 mg powder for concentrate for solution for infusion.
2. Qualitative and quantitative composition
Benlysta 120 mg powder for concentrate for solution for infusion.
Each vial contains 120 mg of belimumab. After reconstitution, the
solution contains 80 mg belimumab
per ml.
Benlysta 400 mg powder for concentrate for solution for infusion.
Each vial contains 400 mg of belimumab. After reconstitution, the
solution contains 80 mg belimumab
per ml.
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
Powder for concentrate for solution for infusion.
White to off-white powder.
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).
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. Benlysta infusions should be
administered by a qualified healthcare
professional trained to give infusion therapy.
Administration of Benlysta may result in severe or life-threatening
hypersensitivity reactions and infusion
reactions. Patients have been reported to develop symptoms of acute
hypersensitivity several hours after
the i