BENLYSTA S.C. 200 MG

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

BELIMUMAB

Διαθέσιμο από:

GLAXO SMITH KLINE (ISRAEL) LTD

Φαρμακολογική κατηγορία (ATC):

L04AA26

Φαρμακοτεχνική μορφή:

SOLUTION FOR INJECTION

Σύνθεση:

BELIMUMAB 200 MG / 1 ML

Οδός χορήγησης:

S.C

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

GLAXO OPERATIONS UK LIMITED

Θεραπευτική περιοχή:

BELIMUMAB

Θεραπευτικές ενδείξεις:

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.Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.

Ημερομηνία της άδειας:

2023-11-30

Φύλλο οδηγιών χρήσης

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician’s prescription
only
Benlysta S.C. 200 mg
Solution for injection in pre-filled pen
Each 1 ml pre-filled pen contains 200 mg belimumab.
For the list of the inactive and allergenic ingredients in the
medicine, see section
2 - “Important information about some of the ingredients in the
medicine” and
section 6 - “Additional information”.
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions,
refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Benlysta Subcutaneous 200 mg is indicated as an 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.
Benlysta, in combination with immunosuppressive therapies, is intended
for the
treatment of adult patients with active lupus nephritis.
Therapeutic group: selective immunosuppressant.
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. The disease can affect almost any organ in the body, and is
thought
to involve a type of white blood cells called B cells.
Benlysta S.C. 200 mg contains belimumab (a human monoclonal antibody).
It
reduces the number of B cells in your blood by blocking the action of
BLyS, a
protein that helps B cells live longer and is found in high levels in
people with
lupus.
You will be given Benlysta S.C. 200 mg in addition to your usual
treatment for
lupus.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
• you are sensitive (allergic) to belimumab or to an

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Benlysta S.C. 200 mg
1.
NAME OF THE MEDICINAL PRODUCT
Benlysta S.C. 200 mg
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).
Limitations of Use: The efficacy of Benlysta has not been evaluated in
patients with severe
active central nervous system lupus. Benlysta has not been studied in
combination with other
biologics. Use of Benlysta is not recommended in these situations.
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 must provide proper training in subcutaneous technique
and education about signs
and symptoms of hypersensitivity reactions (see section 4.4). A
patient may self-inject or the
patient caregiver may administer Benlysta after the h