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

Stem definitionDrug idCAS RN
human origin 5320 1709815-23-5

Description:

MoleculeDescription

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:

DateAgencyCompanyOrphan
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)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Staphylococcal bacteraemia 88.55 77.13 16 144 12202 79732026

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

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

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




🐶 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Interferon gamma Cytokine ANTIBODY BINDING Kd 9.10 IUPHAR DRUG LABEL

External reference:

IDSource
3S252O2Z4X UNII
C4740904 UMLSCUI
CHEMBL3989977 ChEMBL_ID
DB14724 DRUGBANK_ID
D11120 KEGG_DRUG
10319 INN_ID
9295 IUPHAR_LIGAND_ID
017853 NDDF
782980002 SNOMEDCT_US
783023005 SNOMEDCT_US
4038104 VANDF
4038105 VANDF
2104603 RXNORM
300665 MMSL
35691 MMSL
35692 MMSL
d09080 MMSL
C000644327 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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