Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Belimumab
GLAXOSMITHKLINE PTE LTD
L04AA26
120mg/vial
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Belimumab 120mg/vial
INTRAVENOUS
Prescription Only
Hospira, Inc.
ACTIVE
2012-08-21
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 Read the complete document
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 Read the complete document