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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.

Pharmaceutical form

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.

Chemical substance
Description
Belatacept

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.

List of excipients

Sucrose
Sodium dihydrogen phosphate monohydrate
Sodium chloride
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.

Marketing authorization holder
Authorization dates

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

Marketing authorization number:

EU/1/11/694/001-002