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Therapeutic Belatacept antibody from the original Nulojix® commercial drug.
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ProductBatch | Antigen | Molecular Class | Drug Brand | Product Concentration | CoA | Quantity per vial | Storage Temperature | Expiry Date | Price from | |
|---|---|---|---|---|---|---|---|---|---|---|
CD80 , CD86 |
Fusion protein |
Nulojix® |
25 mg/mL |
– |
5 mg |
-80°C |
01/2025 |
214,00 € |
| Drug name | Nulojix® |
| INN | Belatacept |
| API type | Belatacept 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 function | Nulojix 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 numbers | EU/1/11/694/001-002 |
| Marketing authorisation holder | Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland |
| Name of the manufacturer of the biological active substance | Bristol-Myers Squibb Company 6000 Thompson Road, East Syracuse New York 13057 – U.S.A. |
| Name and address of the manufacturer(s) responsible for batch release | Swords 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) |
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