Benlysta Powder for Solution for Infusion 120mg

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

Belimumab

זמין מ:

GLAXOSMITHKLINE PTE LTD

קוד ATC:

L04AA26

כמות:

120mg/vial

טופס פרצבטיות:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

הרכב:

Belimumab 120mg/vial

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

Prescription Only

תוצרת:

Hospira, Inc.

מצב אישור:

ACTIVE

תאריך אישור:

2012-08-21

עלון מידע

BENLYSTA
TM

BELIMUMAB 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Sterile lyophilized powder in a single use vial.   
120 mg vial 
Each vial contains a sufficient amount of belimumab to deliver 120
mg in 1.5 mL when 
reconstituted as recommended with sterile Water for Injection .
After reconstitution, each 
mL of solution contains 80 mg belimumab. 
400 mg vial 
Each vial contains a sufficient amount of belimumab to deliver 400
mg in 5.0 mL when 
reconstituted as recommended with sterile water for injection.
 After reconstitution, each 
mL of solution contains 80 mg belimumab. 
Belimumab is a recombinant, fully human, IgG1λ monoclonal
antibody. 
PHARMACEUTICAL FORM 
Powder for solution for infusion. 
CLINICAL PARTICULARS 
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 Clinical _
_Studies_). 
DOSAGE AND ADMINISTRATION 
_BENLYSTA_ is administered intravenously by infusion, and must be
reconstituted and 
diluted prior to administration (_see Use and Handling_). 
_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 hypersensitivity
reactions and infusion 
reactions. Therefore, _BENLYSTA_ should be administered in an
environment where 
resources for managing such reactions are immediately available. 

_BENLYSTA_ should be administered by a healthcare professional
prepared to treat 
hypersensitivity reactions including anaphylaxis. 
_BENLYSTA_ should be infused over a 1-hour period.  
_BENLYSTA_ must not be administered as an intravenous push or
bolus. 
The infusion rat

מאפייני מוצר

BENLYSTA
BELIMUMAB
QUALITATIVE AND QUANTITATIVE COMPOSITION
White to off-white powder.
120 mg vial
Each vial contains 120 mg belimumab (80 mg/mL after reconstitution).
400 mg vial
Each vial contains 400 mg belimumab (80 mg/mL after reconstitution).
Belimumab is a human IgG1λ monoclonal antibody specific for soluble
human B
Lymphocyte Stimulator protein (BLyS). Belimumab is produced by
recombinant DNA
technology in a mammalian cell expression system.
CLINICAL INFORMATION
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 _
_Clinical Studies_).

In combination with background immunosuppressive therapies for
treatment
of active lupus nephritis in adult patients.
DOSAGE AND ADMINISTRATION
Pharmaceutical form: Powder for concentrate for solution for infusion.
Lyophilised powder for intravenous infusion
_BENLYSTA _is administered intravenously by infusion, and must be
reconstituted and
diluted prior to administration (_see Instructions for Use/Handling_).
_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 hypersensitivity reactions
and infusion
reactions. Therefore, _BENLYSTA _should be administered in an
environment where
resources for managing such reactions are immediately available.
_BENLYSTA _should be administered by a healthcare professional
prepared to treat
hypersensitivity reactions including anaphylaxis.
_BENLYSTA _should be infused over a 1-hour period.
_BENLYSTA _must not be administered as an intravenous push or bolus.
The infusion rate may be slowed or interrupted if the patient develops
an infusion
reaction. The infusion must be discontinued immediately i