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| Stem definition | Drug id | CAS RN |
|---|---|---|
| human origin | 5320 | 1709815-23-5 |
| Molecule | Description |
|---|---|
|
Synonyms:
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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.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 20, 2018 | FDA | NOVIMMUNE S.A. |
| 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 |
|---|---|---|---|---|---|---|
| Off label use | 109.28 | 98.13 | 75 | 540 | 1102177 | 89525655 |
| 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 |
|---|---|---|---|---|---|---|
| Off label use | 102.22 | 87.20 | 73 | 449 | 638262 | 41982551 |
| 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 |
|---|---|---|---|---|---|---|
| Off label use | 180.46 | 79.18 | 130 | 903 | 1500055 | 109088211 |
| Haemophagocytic lymphohistiocytosis | 91.09 | 79.18 | 26 | 1007 | 31533 | 110556733 |
| Adenovirus infection | 80.47 | 79.18 | 19 | 1014 | 10975 | 110577291 |
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| Source | Code | Description |
|---|---|---|
| ATC | L04AG09 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Monoclonal antibodies |
| FDA MoA | N0000193855 | Interferon gamma Antagonists |
| FDA EPC | N0000193856 | Interferon gamma Blocker |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:35705 | immunosuppressive agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Primary hemophagocytic lymphohistiocytosis | indication | 724641002 | |
| Coronavirus infection | off-label use | 186747009 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Interferon gamma | Cytokine | ANTIBODY BINDING | Kd | 9.10 | IUPHAR | DRUG LABEL |
| ID | Source |
|---|---|
| 3S252O2Z4X | UNII |
| 4038104 | VANDF |
| 4038105 | VANDF |
| C4740904 | UMLSCUI |
| CHEBI:756460 | CHEBI |
| CHEMBL3989977 | ChEMBL_ID |
| DB14724 | DRUGBANK_ID |
| D11120 | KEGG_DRUG |
| 10319 | INN_ID |
| C000644327 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9295 | IUPHAR_LIGAND_ID |
| 782980002 | SNOMEDCT_US |
| 783023005 | SNOMEDCT_US |
| 300665 | MMSL |
| 35691 | MMSL |
| 35692 | MMSL |
| d09080 | MMSL |
| 017853 | NDDF |
| 2104603 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| GAMIFANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66658-501 | INJECTION | 10 mg | INTRAVENOUS | BLA | 28 sections |
| GAMIFANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66658-505 | INJECTION | 50 mg | INTRAVENOUS | BLA | 28 sections |
| GAMIFANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66658-510 | INJECTION | 100 mg | INTRAVENOUS | BLA | 28 sections |
| GAMIFANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66658-522 | INJECTION | 50 mg | INTRAVENOUS | BLA | 28 sections |
| GAMIFANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66658-523 | INJECTION | 100 mg | INTRAVENOUS | BLA | 28 sections |
| GAMIFANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66658-524 | INJECTION | 250 mg | INTRAVENOUS | BLA | 28 sections |
| GAMIFANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66658-525 | INJECTION | 500 mg | INTRAVENOUS | BLA | 28 sections |