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

Stem definition	Drug id	CAS RN
human origin	4923	946414-94-4

Description:

Molecule	Description
Synonyms: nivolumab opdivo MDX-1106 ONO-4538 BMS-936558 nivolumab (genetical recombination)	A genetically engineered, fully humanized immunoglobulin G4 monoclonal antibody that binds to the PD-1 RECEPTOR, activating an immune response to tumor cells. It is used as monotherapy or in combination with IPILIMUMAB for the treatment of advanced malignant MELANOMA. It is also used in the treatment of advanced or recurring NON-SMALL CELL LUNG CANCER; RENAL CELL CARCINOMA; and HODGKIN'S LYMPHOMA. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

nivolumab
opdivo
MDX-1106
ONO-4538
BMS-936558
nivolumab (genetical recombination)

A genetically engineered, fully humanized immunoglobulin G4 monoclonal antibody that binds to the PD-1 RECEPTOR, activating an immune response to tumor cells. It is used as monotherapy or in combination with IPILIMUMAB for the treatment of advanced malignant MELANOMA. It is also used in the treatment of advanced or recurring NON-SMALL CELL LUNG CANCER; RENAL CELL CARCINOMA; and HODGKIN'S LYMPHOMA.

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

Drug dosage:

None

ADMET properties:

None

Approvals:

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Date	Agency	Company
Dec. 22, 2014	FDA	BRISTOL MYERS SQUIBB
July 4, 2014	PMDA	Ono Pharmaceutical Co., Ltd
June 19, 2015	EMA	Bristol-Myers Squibb

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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
Malignant neoplasm progression	5470.44	16.51	2141	47620	79980	63359281
Death	1511.58	16.51	1650	48111	372731	63066530
Intentional product use issue	1230.99	16.51	922	48839	126970	63312291
Immune-mediated enterocolitis	1016.81	16.51	252	49509	1859	63437402
Pneumonitis	908.99	16.51	476	49285	34746	63404515
Hypophysitis	892.89	16.51	221	49540	1620	63437641
Colitis	890.86	16.51	524	49237	48004	63391257
Hypothyroidism	731.90	16.51	441	49320	42191	63397070
Fulminant type 1 diabetes mellitus	585.16	16.51	122	49639	353	63438908
Immune-mediated hepatitis	538.16	16.51	139	49622	1232	63438029

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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
Malignant neoplasm progression	8424.76	14.16	4256	88367	83790	34780518
Immune-mediated enterocolitis	1397.76	14.16	448	92175	2351	34861957
Intentional product use issue	1361.18	14.16	1184	91439	58632	34805676
Hypothyroidism	1288.55	14.16	760	91863	20142	34844166
Pneumonitis	1205.94	14.16	873	91750	33005	34831303
Death	1180.82	14.16	2971	89652	395078	34469230
Adrenal insufficiency	1160.23	14.16	619	92004	13428	34850880
Colitis	1086.99	14.16	857	91766	36893	34827415
Hypophysitis	1028.03	14.16	338	92285	1948	34862360
Fulminant type 1 diabetes mellitus	918.31	14.16	250	92373	641	34863667

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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
Malignant neoplasm progression	12666.32	13.20	5550	124182	130440	79484216
Immune-mediated enterocolitis	2185.39	13.20	640	129092	4190	79610466
Pneumonitis	1910.05	13.20	1205	128527	59655	79555001
Hypothyroidism	1887.81	13.20	1133	128599	51259	79563397
Colitis	1768.89	13.20	1232	128500	72075	79542581
Hypophysitis	1753.41	13.20	522	129210	3644	79611012
Death	1668.64	13.20	3155	126577	563359	79051297
Adrenal insufficiency	1659.96	13.20	846	128886	27641	79587015
Intentional product use issue	1568.23	13.20	1561	128171	150551	79464105
Fulminant type 1 diabetes mellitus	1490.03	13.20	369	129363	1114	79613542

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L01FF01	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors
ATC	L01XY03	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Combinations of antineoplastic agents
FDA EPC	N0000191260	Programmed Death Receptor-1 Blocking Antibody
FDA MoA	N0000191259	Programmed Death Receptor-1-directed Antibody Interactions
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D000074322	Antineoplastic Agents, Immunological
MeSH PA	D000082082	Immune Checkpoint Inhibitors

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

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Disease	Relation	SNOMED_ID	DOID
Transitional cell carcinoma	indication	27090000	DOID:2671
Squamous cell carcinoma of lung	indication	254634000	DOID:3907
Non-small cell lung cancer	indication	254637007	DOID:3908
Unresectable advanced or recurrent malignant pleural mesothelioma	indication	254645002	DOID:7474
Head and neck cancer	indication	255055008	DOID:11934
Unresectable, advanced or recurrent gastric cancer	indication	276810009
Malignant tumor of stomach	indication	363349007	DOID:10534
Malignant tumor of esophagus	indication	363402007
Advanced melanoma with tumour cell PD-L1 expression below 1%	indication	443493003
Metastatic malignant melanoma	indication	443493003

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🐶 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
Programmed cell death protein 1	Membrane receptor	Q15116	PDCD1_HUMAN	ANTIBODY BINDING	Kd	9.14		IUPHAR	SCIENTIFIC LITERATURE

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External reference:

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ID	Source
015839	NDDF
1597876	RXNORM
231573	MMSL
30781	MMSL
31YO63LBSN	UNII
4034032	VUID
4034032	VANDF
704191007	SNOMEDCT_US
704192000	SNOMEDCT_US
7335	IUPHAR_LIGAND_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3734	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3734	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3734	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3734	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3756	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3756	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3756	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3756	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3772	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections
OPDIVO	HUMAN PRESCRIPTION DRUG LABEL	1	0003-3772	INJECTION	10 mg	INTRAVENOUS	BLA	24 sections

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