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

Stem definition	Drug id	CAS RN
human origin	5320	1709815-23-5

Description:

Molecule	Description
Synonyms: emapalumab gamifant NI-0501 emapalumab-lzsg	Emapalumab-lzsg is a monoclonal antibody that binds to and neutralizes interferon gamma (IFNgamma). Nonclinical data suggest that IFNgamma plays a pivotal role in the pathogenesis of HLH by being hypersecreted. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

emapalumab
gamifant
NI-0501
emapalumab-lzsg

Emapalumab-lzsg is a monoclonal antibody that binds to and neutralizes interferon gamma (IFNgamma). Nonclinical data suggest that IFNgamma plays a pivotal role in the pathogenesis of HLH by being hypersecreted.

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

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Nov. 20, 2018	FDA	NOVIMMUNE S.A.

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

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
Staphylococcal bacteraemia	88.55	77.13	16	144	12202	79732026

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L04AA39	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants
FDA EPC	N0000193856	Interferon gamma Blocker
FDA MoA	N0000193855	Interferon gamma Antagonists

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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
Primary hemophagocytic lymphohistiocytosis	indication	724641002
Coronavirus infection	off-label use	186747009

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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
Interferon gamma	Cytokine	P01579	IFNG_HUMAN	ANTIBODY BINDING	Kd	9.10		IUPHAR	DRUG LABEL

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External reference:

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ID	Source
017853	NDDF
10319	INN_ID
2104603	RXNORM
300665	MMSL
35691	MMSL
35692	MMSL
3S252O2Z4X	UNII
4038104	VANDF
4038105	VANDF
782980002	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
GAMIFANT	HUMAN PRESCRIPTION DRUG LABEL	1	66658-501	INJECTION	10 mg	INTRAVENOUS	BLA	25 sections
GAMIFANT	HUMAN PRESCRIPTION DRUG LABEL	1	66658-501	INJECTION	10 mg	INTRAVENOUS	BLA	25 sections
GAMIFANT	HUMAN PRESCRIPTION DRUG LABEL	1	66658-505	INJECTION	50 mg	INTRAVENOUS	BLA	25 sections
GAMIFANT	HUMAN PRESCRIPTION DRUG LABEL	1	66658-505	INJECTION	50 mg	INTRAVENOUS	BLA	25 sections
GAMIFANT	HUMAN PRESCRIPTION DRUG LABEL	1	66658-510	INJECTION	100 mg	INTRAVENOUS	BLA	25 sections
GAMIFANT	HUMAN PRESCRIPTION DRUG LABEL	1	66658-510	INJECTION	100 mg	INTRAVENOUS	BLA	25 sections

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