NULOJIX Powder for concentrate for solution for infusion (2020)
Active ingredients: Belatacept
Product Name and Form
NULOJIX 250 mg powder for concentrate for solution for infusion.
Powder for concentrate for solution for infusion (powder for concentrate).
The powder is a white to off-white whole or fragmented cake.
Qualitative and Quantitative Composition
Each vial contains 250 mg of belatacept. After reconstitution, each ml of concentrate contains 25 mg belatacept.
Belatacept is a fusion protein produced in Chinese hamster ovary cells by recombinant DNA technology.
Excipient with known effect: Each vial contains 0.65 mmol sodium.
For the full list of excipients, see section 6.1.
Belatacept, a modified form of CTLA4-Ig, binds CD80 and CD86 more avidly than the parent CTLA4-Ig molecule from which it is derived. This increased avidity provides a level of immunosuppression that is necessary for preventing immune-mediated allograft failure and dysfunction. Belatacept blocks CD28 mediated co-stimulation of T cells inhibiting their activation.
Sodium dihydrogen phosphate monohydrate
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Pack sizes and Marketing
NULOJIX is supplied in a 20 ml vial (Type I flint glass) with a stopper (20 mm grey butyl rubber) and flip off seal (aluminum). Each vial is co-packaged with a disposable polypropylene syringe.
Pack sizes: 1 vial and 1 syringe or 2 vials and 2 syringes.
Not all pack-sizes may be marketed.
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Date of first authorisation: 17 June 2011
Date of latest renewal: 18 February 2016