BENLYSTA I.V. 120 MG

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

BELIMUMAB

Dostopno od:

GLAXO SMITH KLINE (ISRAEL) LTD

Koda artikla:

L04AA26

Farmacevtska oblika:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Sestava:

BELIMUMAB 120 MG

Pot uporabe:

I.V

Tip zastaranja:

Required

Izdeluje:

GLAXO GROUP LTD, UK

Terapevtska skupina:

BELIMUMAB

Terapevtsko območje:

BELIMUMAB

Terapevtske indikacije:

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.

Datum dovoljenje:

2017-01-31

Navodilo za uporabo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician’s prescription
only
Benlysta I.V. 120 mg
Powder for concentrate for solution for infusion
Each vial contains:
120 mg of belimumab (80 mg/ml after reconstitution)
Benlysta I.V. 400 mg
Powder for concentrate for solution for infusion
Each vial contains:
400 mg of belimumab (80 mg/ml after reconstitution)
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 is indicated as an add-on therapy in patients from the age of
5 years and up
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 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 to live
longer and is found in high levels in people with lupus.
You will be given Benlysta

Lastnosti izdelka

Page 1 of 24
Benlysta I.V. 120 mg
Benlysta I.V. 400 mg
1.
NAME OF THE MEDICINAL PRODUCT
Benlysta I.V. 120 mg
Benlysta I.V. 400 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Benlysta I.V. 120 mg:
Each vial contains 120 mg of belimumab.
After reconstitution, the solution contains 80 mg belimumab per mL.
Benlysta I.V. 400 mg:
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 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 (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
Page 2 of 24
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
infusion has been administered. Recurrence of clinically significant
reacti