satralizumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
humanized origin 5409 1535963-91-7

Description:

MoleculeDescription

Molfile

Synonyms:

  • satralizumab
  • satralizumab-mwge
  • enspryng
  • SA237
  • SA-237
  • RG-6168
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.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
4.30 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Aug. 14, 2020 FDA GENENTECH
June 29, 2020 PMDA Chugai Pharmaceutical Co., Ltd.
June 24, 2021 EMA Roche Registration GmbH

FDA Adverse Event Reporting System (Female)

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
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

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
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

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AC19 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Interleukin inhibitors
CHEBI has role CHEBI:35674 antihypertensive agent

Related Drugs by ATC class:

L04AC Interleukin inhibitors 18 drugs
anakinrabasiliximabbimekizumabbrodalumabcanakinumabdaclizumabguselkumabixekizumabmirikizumabrilonaceptrisankizumabsarilumab show all 18 →

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

DiseaseRelationSNOMED_IDDOID
Neuromyelitis optica indication 25044007 DOID:8869
Tuberculosis contraindication 56717001
Viral hepatitis type B contraindication 66071002 DOID:2043




🐶 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
Interleukin-6 receptor subunit alpha Cytokine ANTAGONIST Kd 8.82 DRUG LABEL DRUG LABEL

External reference:

IDSource
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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Enspryng HUMAN PRESCRIPTION DRUG LABEL 1 50242-007 INJECTION, SOLUTION 120 mg SUBCUTANEOUS BLA 29 sections