Active ingredients: Belimumab
Benlysta 200 mg solution for injection in pre-filled pen.
Benlysta 200 mg solution for injection in pre-filled syringe.
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.
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.
Belimumab is a human IgG1λ monoclonal antibody specific for soluble human B Lymphocyte Stimulator protein (BLyS, also referred to as BAFF and TNFSF13B). Belimumab blocks the binding of soluble BLyS, a B cell survival factor, to its receptors on B cells. Belimumab by binding BLyS inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
Arginine hydrochloride
Histidine
Histidine monohydrochloride
Polysorbate 80
Sodium chloride
Water for injections
Pre-filled pen:
1 ml solution in a type 1 glass syringe with a fixed needle (stainless steel) in a pre-filled pen.
Available in packs of 1 or 4 pre-filled pens and multipack containing 12 single-dose pre-filled pens (3 packs of 4 pre-filled pens).
Not all pack sizes may be marketed.
Pre-filled syringe:
1 ml solution in a type 1 glass syringe with a fixed needle (stainless steel) and needle cap.
Available in pack of 1 pre-filled syringe and pack of 4 pre-filled syringes.
Not all pack sizes may be marketed.
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
EU/1/11/700/003 1 pre-filled pen
EU/1/11/700/004 4 pre-filled pens
EU/1/11/700/005 12 (3x4) pre-filled pens (multipack)
EU/1/11/700/006 1 pre-filled syringe
EU/1/11/700/007 4 pre-filled syringes
Date of first authorisation: 13 July 2011
Date of latest renewal: 18 February 2016