belatacept 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) receptors	5091	706808-37-9

Description:

Molecule	Description
Synonyms: belatacept BMS-224818 nulojix BMS 224818	Belatacept, a selective T-cell (lymphocyte) costimulation blocker, binds to CD80 and CD86 on antigen-presenting cells thereby blocking CD28 mediated costimulation of T lymphocytes. In vitro, belatacept inhibits T lymphocyte proliferation and the production of the cytokines interleukin-2, interferon-gamma, interleukin-4, and TNF-alfa. Activated T lymphocytes are the predominant mediators of immunologic rejection Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

belatacept
BMS-224818
nulojix
BMS 224818

Belatacept, a selective T-cell (lymphocyte) costimulation blocker, binds to CD80 and CD86 on antigen-presenting cells thereby blocking CD28 mediated costimulation of T lymphocytes. In vitro, belatacept inhibits T lymphocyte proliferation and the production of the cytokines interleukin-2, interferon-gamma, interleukin-4, and TNF-alfa. Activated T lymphocytes are the predominant mediators of immunologic rejection

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
12.50	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
June 15, 2011	FDA	BRISTOL MYERS SQUIBB
June 17, 2011	EMA

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Transplant rejection	228.22	38.90	55	1863	10725	63476379
Kidney transplant rejection	207.40	38.90	43	1875	4228	63482876
Polyomavirus viraemia	143.86	38.90	24	1894	710	63486394
Cytomegalovirus infection	135.27	38.90	42	1876	20910	63466194
Graft loss	107.51	38.90	17	1901	356	63486748
Thrombotic microangiopathy	106.86	38.90	30	1888	10531	63476573
Pneumocystis jirovecii pneumonia	80.81	38.90	27	1891	16887	63470217
Cytomegalovirus gastrointestinal infection	73.92	38.90	12	1906	298	63486806
Cervicitis	61.37	38.90	11	1907	497	63486607
Eye infection toxoplasmal	60.26	38.90	10	1908	285	63486819

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Kidney transplant rejection	293.42	34.10	75	2554	7422	34946880
Transplant rejection	215.56	34.10	63	2566	10248	34944054
Cytomegalovirus infection	110.98	34.10	49	2580	26086	34928216
COVID-19	90.99	34.10	62	2567	77488	34876814
Graft loss	88.61	34.10	19	2610	864	34953438
Post transplant lymphoproliferative disorder	73.86	34.10	25	2604	6503	34947799
Thrombotic microangiopathy	72.51	34.10	28	2601	10602	34943700
Alternaria infection	71.96	34.10	14	2615	389	34953913
BK virus infection	65.01	34.10	22	2607	5716	34948586
Pneumocystis jirovecii pneumonia	58.86	34.10	29	2600	19681	34934621

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Kidney transplant rejection	418.86	32.60	99	4094	10147	79730048
Transplant rejection	346.77	32.60	97	4096	19340	79720855
Cytomegalovirus infection	234.39	32.60	87	4106	42557	79697638
Pneumocystis jirovecii pneumonia	166.40	32.60	63	4130	32445	79707750
Graft loss	165.63	32.60	31	4162	1012	79739183
Post transplant lymphoproliferative disorder	149.92	32.60	45	4148	11419	79728776
Thrombotic microangiopathy	144.01	32.60	50	4143	20119	79720076
COVID-19	133.72	32.60	90	4103	157584	79582611
Polyomavirus viraemia	115.90	32.60	25	4168	1682	79738513
Off label use	82.87	32.60	160	4033	907055	78833140

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L04AA28	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants
FDA EPC	N0000182830	Selective T Cell Costimulation Blocker
FDA MoA	N0000182150	CD80-directed Antibody Interactions
FDA MoA	N0000182151	CD86-directed Antibody Interactions
FDA PE	N0000182829	T Lymphocyte Costimulation Activity Blockade
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D000074322	Antineoplastic Agents, Immunological
MeSH PA	D018501	Antirheumatic Agents
MeSH PA	D000082082	Immune Checkpoint Inhibitors
MeSH PA	D007155	Immunologic Factors

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Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Renal transplant rejection	indication	236570004

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
T-lymphocyte activation antigen CD80	Surface antigen	P33681	CD80_HUMAN	INHIBITOR				DRUG LABEL	DRUG LABEL
T-lymphocyte activation antigen CD86	Surface antigen	P42081	CD86_HUMAN	INHIBITOR				DRUG LABEL	DRUG LABEL

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External reference:

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ID	Source
013827	NDDF
1112973	RXNORM
183036	MMSL
27948	MMSL
4030905	VANDF
6892	IUPHAR_LIGAND_ID
713475001	SNOMEDCT_US
714777004	SNOMEDCT_US
8627	INN_ID
C1619962	UMLSCUI

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
NULOJIX	HUMAN PRESCRIPTION DRUG LABEL	1	0003-0371	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	250 mg	INTRAVENOUS	BLA	30 sections
NULOJIX	HUMAN PRESCRIPTION DRUG LABEL	1	0003-0371	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	250 mg	INTRAVENOUS	BLA	30 sections

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