Belatacept

Therapeutic Belatacept antibody from the original Nulojix® commercial drug.

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Antigen
Molecular Class
Drug Brand
Product Concentration
CoA
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Expiry Date
Price
CD80
,
CD86
Fusion protein
Nulojix®
25 mg/mL
5 mg
-80°C
01/2025
235,00 
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Nulojix® / Belatacept Reference Product

Drug nameNulojix®
INNBelatacept
API typeBelatacept is a fusion protein produced in Chinese hamster ovary cells by recombinant DNA technology.
Pharmacotherapeutic group
Immunosuppressants, selective immunosuppressants
ATC code
L04AA28
Target of antibody
CD80, CD86
General functionNulojix is used in adults to prevent the body from rejecting a transplanted kidney. It is used with corticosteroids and a mycophenolic acid (other medicines used to prevent organ rejection). An interleukin-2-receptor-antagonist medicine should also be used with Nulojix during the first week after the kidney transplant.
The medicine can only be obtained with a prescription.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Belatacept binds to CD80 and CD86 on antigen presenting cells. As a result, belatacept blocks CD28 mediated co-stimulation of T cells inhibiting their activation. Activated T cells are the predominant mediators of immunologic response to the transplanted kidney. 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.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)In a clinical study, approximately 90% saturation of CD86 receptors on the surface of antigenpresenting cells in the peripheral blood was observed following the initial administration of belatacept. During the first month post-transplantation, 85% saturation of CD86 was maintained. Up to month 3 post-transplantation with the recommended dosing regimen, the level of CD86 saturation was maintained at approximately 70% and at month 12, approximately 65%.
Original license holder
Marketing authorisation numbersEU/1/11/694/001-002
Marketing authorisation holderBristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Name of the manufacturer of the biological active substanceBristol-Myers Squibb Company
6000 Thompson Road, East Syracuse
New York 13057 – U.S.A.
Name and address of the manufacturer(s) responsible for batch releaseSwords Laboratories Unlimited Company T/A Bristol-Myers Squibb Cruiserath Biologics
Cruiserath Road, Mulhuddart
Dublin 15, D15 H6EF
Ireland
Max shelf life
36 months
Storage conditions
2°C – 8°C
List of excipients
Sucrose
Sodium dihydrogen phosphate monohydrate
Sodium chloride
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Evidentic Support
+49 (0) 30 959 99 8831

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