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| Stem definition | Drug id | CAS RN |
|---|---|---|
| humanized origin | 5409 | 1535963-91-7 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. It is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients. The precise mechanism by which satralizumab-mwge exerts therapeutic effects in NMOSD is unknown but is presumed to involve inhibition of IL-6-mediated signaling through binding to soluble and membrane-bound IL-6 receptors.
|
| Dose | Unit | Route |
|---|---|---|
| 4.30 | mg | P |
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 14, 2020 | FDA | GENENTECH | |
| June 29, 2020 | PMDA | Chugai Pharmaceutical Co., Ltd. | |
| June 24, 2021 | EMA | Roche Registration GmbH |
| 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 |
|---|---|---|---|---|---|---|
| Optic neuritis | 105.64 | 35.62 | 25 | 1253 | 9653 | 90617516 |
| Urinary tract infection | 98.23 | 35.62 | 58 | 1220 | 305574 | 90321595 |
| Myelitis | 72.47 | 35.62 | 14 | 1264 | 2064 | 90625105 |
| Pyelonephritis | 64.41 | 35.62 | 20 | 1258 | 21296 | 90605873 |
| COVID-19 | 56.51 | 35.62 | 33 | 1245 | 168810 | 90458359 |
| Off label use | 50.53 | 35.62 | 69 | 1209 | 1102183 | 89524986 |
| Fracture | 39.67 | 35.62 | 14 | 1264 | 22062 | 90605107 |
| Lymphocyte count decreased | 36.77 | 35.62 | 15 | 1263 | 35035 | 90592134 |
| Cellulitis | 36.28 | 35.62 | 20 | 1258 | 91317 | 90535852 |
| Hepatic function abnormal | 35.93 | 35.62 | 16 | 1262 | 46272 | 90580897 |
None
| 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 |
|---|---|---|---|---|---|---|
| Urinary tract infection | 93.18 | 37.90 | 53 | 1191 | 326229 | 110261826 |
| Optic neuritis | 92.00 | 37.90 | 22 | 1222 | 11125 | 110576930 |
| COVID-19 | 59.71 | 37.90 | 36 | 1208 | 245024 | 110343031 |
| Pyelonephritis | 48.88 | 37.90 | 16 | 1228 | 25234 | 110562821 |
| Cellulitis | 45.52 | 37.90 | 24 | 1220 | 125992 | 110462063 |
| Hepatic function abnormal | 38.00 | 37.90 | 19 | 1225 | 89276 | 110498779 |
None
| Source | Code | Description |
|---|---|---|
| ATC | L04AC19 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Interleukin inhibitors |
| CHEBI has role | CHEBI:35674 | antihypertensive agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Neuromyelitis optica | indication | 25044007 | DOID:8869 |
| Tuberculosis | contraindication | 56717001 | |
| Viral hepatitis type B | contraindication | 66071002 | DOID:2043 |
None
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Interleukin-6 receptor subunit alpha | Cytokine | ANTAGONIST | Kd | 8.82 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| D11079 | KEGG_DRUG |
| YB18NF020M | UNII |
| C4726732 | UMLSCUI |
| CHEBI:755907 | CHEBI |
| CHEMBL3833307 | ChEMBL_ID |
| DB15762 | DRUGBANK_ID |
| 10065 | INN_ID |
| C000655944 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9093 | IUPHAR_LIGAND_ID |
| 897234001 | SNOMEDCT_US |
| 897291006 | SNOMEDCT_US |
| 4039644 | VANDF |
| 4039645 | VANDF |
| 337831 | MMSL |
| 38756 | MMSL |
| d09618 | MMSL |
| 018474 | NDDF |
| 2391541 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Enspryng | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-007 | INJECTION, SOLUTION | 120 mg | SUBCUTANEOUS | BLA | 29 sections |