Drug name | Yervoy®
|
INN | Ipilimumab |
API type | Ipilimumab is a fully human anti-CTLA-4 monoclonal antibody (IgG1κ) produced in Chinese hamster ovary cells by recombinant DNA technology. |
Pharmacotherapeutic group
| Antineoplastic agents, monoclonal antibodies |
ATC code
| L01XC11 |
Target of antibody
| CD152-CTLA4 |
General function | Ipilimumab is a CTLA-4 immune checkpoint inhibitor that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of reactive T-effector cells which mobilize to mount a direct T-cell immune attack against tumour cells. |
Short description | |
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
| Cytotoxic T-lymphocyte antigen-4 (CTLA-4) is a key regulator of T-cell activity. Ipilimumab is a CTLA-4 immune checkpoint inhibitor that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of reactive T-effector cells which mobilize to mount a direct T-cell immune attack against tumour cells. CTLA-4 blockade can also reduce T-regulatory cell function, which may contribute to an anti-tumour immune response. |
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Ipilimumab is an Antineoplastic agent, and may selectively deplete T-regulatory cells at the tumour site, leading to an increase in the intratumoral T-effector/ T-regulatory cell ratio which drives tumour cell death. |
Original license holder
| Bristol-Myers Squibb Pharma EEIG |
Marketing authorisation numbers
| EU/1/11/698/001-002 |
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
United States
Samsung Biologics Co. Ltd
300, Songdo Bio Way (Daero)
Yeonsu-gu, Incheon 21987
Korea |
Name and address of the manufacturer(s) responsible for batch release | CATALENT ANAGNI S.R.L.
Loc. Fontana del Ceraso snc
Strada Provinciale 12 Casilina, 41
03012 Anagni (FR)
Italy
Swords Laboratories T/A Bristol-Myers Squibb Cruiserath Biologics
Cruiserath Road, Mulhuddart
Dublin 15, D15 H6EF
Ireland |
Max shelf life
| 3 years
|
Storage conditions
| 2°C – 8°C
|
List of excipients
| Tris hydrochloride (2-amino-2-hydroxymethyl-1,3-propanediol hydrochloride)
Sodium chloride
Mannitol (E421)
Pentetic acid (diethylenetriaminepentaacetic acid)
Polysorbate 80
Sodium hydroxide (for pH-adjustment)
Hydrochloric acid (for pH-adjustment) |
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