belimumab Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
human origin 4949 356547-88-1

Description:

MoleculeDescription

Synonyms:

  • belimumab
  • benlysta
  • LymphoStat B
  • LymphoStat-B
monoclonal antibody directed against human BLyS protein (B lymphocyte stimulator) for treatment of autoimmune diseases
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
25 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 27, 2017 PMDA GlaxoSmithKline KK
July 13, 2011 EMA Glaxo Group Ltd.
March 9, 2011 FDA HUMAN GENOME SCIENCES INC.

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
Systemic lupus erythematosus 693.65 18.29 310 8920 64870 46611962
Lupus nephritis 259.78 18.29 65 9165 2181 46674651
SLE arthritis 140.35 18.29 31 9199 596 46676236
Therapy cessation 114.03 18.29 69 9161 26560 46650272
Therapy interrupted 109.97 18.29 50 9180 10741 46666091
Systemic lupus erythematosus rash 85.69 18.29 24 9206 1248 46675584
Leukopenia 67.26 18.29 75 9155 68268 46608564
Pleuritic pain 59.95 18.29 28 9202 6388 46670444
Coombs positive haemolytic anaemia 58.91 18.29 14 9216 376 46676456
Antinuclear antibody negative 54.45 18.29 12 9218 228 46676604
Proteinuria 53.66 18.29 36 9194 16517 46660315
Central nervous system lupus 51.01 18.29 9 9221 49 46676783
Lupus pneumonitis 50.12 18.29 9 9221 55 46676777
Herpes simplex reactivation 49.61 18.29 12 9218 348 46676484
Antiphospholipid syndrome 46.05 18.29 16 9214 1696 46675136
Rhesus antigen positive 44.47 18.29 9 9221 111 46676721
Renal vascular thrombosis 43.49 18.29 8 9222 57 46676775
Exposure during pregnancy 39.38 18.29 74 9156 108138 46568694
Parotid gland enlargement 35.91 18.29 11 9219 783 46676049
Gastritis haemorrhagic 34.15 18.29 12 9218 1314 46675518
Product dose omission issue 33.93 18.29 91 9139 168429 46508403
Arthralgia 33.83 18.29 152 9078 364451 46312381
Vasculitis 33.28 18.29 25 9205 13686 46663146
Pyrexia 32.80 18.29 146 9084 348656 46328176
Headache 31.48 18.29 181 9049 478171 46198661
Malaise 31.40 18.29 139 9091 331093 46345739
Urinary tract infection 29.41 18.29 103 9127 220163 46456669
Complex regional pain syndrome 28.98 18.29 12 9218 2054 46674778
Blood immunoglobulin M decreased 28.58 18.29 9 9221 702 46676130
Product storage error 27.51 18.29 21 9209 11771 46665061
Immunoglobulins decreased 27.04 18.29 9 9221 837 46675995
Hyperparathyroidism secondary 27.01 18.29 10 9220 1272 46675560
Cutaneous lupus erythematosus 26.64 18.29 12 9218 2517 46674315
Blood albumin increased 26.63 18.29 9 9221 877 46675955
Triple negative breast cancer 26.43 18.29 6 9224 131 46676701
Complement factor decreased 25.85 18.29 5 9225 48 46676784
Surgery 25.59 18.29 30 9200 28755 46648077
Abortion spontaneous 25.54 18.29 37 9193 43609 46633223
Lymphopenia 24.71 18.29 22 9208 15271 46661561
Toxicity to various agents 24.28 18.29 6 9224 211760 46465072
Cytomegalovirus enteritis 23.94 18.29 6 9224 202 46676630
Hospitalisation 23.85 18.29 44 9186 63341 46613491
Chills 23.63 18.29 56 9174 95976 46580856
Blood immunoglobulin G decreased 23.36 18.29 10 9220 1858 46674974
Anxiety disorder 22.90 18.29 12 9218 3499 46673333
COVID-19 22.89 18.29 23 9207 18552 46658280
Serositis 21.51 18.29 7 9223 607 46676225
Live birth 21.08 18.29 17 9213 10313 46666519
Insurance issue 20.54 18.29 9 9221 1769 46675063
Mean cell haemoglobin increased 19.54 18.29 9 9221 1987 46674845
Skin disorder 19.45 18.29 23 9207 22240 46654592
Drug intolerance 19.30 18.29 3 9227 147046 46529786
Appendicitis 18.51 18.29 13 9217 6413 46670419

FDA Adverse Event Reporting System (Male)

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
Systemic lupus erythematosus 181.53 41.52 32 459 2524 29949463
Progressive multifocal leukoencephalopathy 68.92 41.52 18 473 8995 29942992
T-lymphocyte count decreased 46.41 41.52 7 484 202 29951785

Pharmacologic Action:

SourceCodeDescription
ATC L04AA26 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Selective immunosuppressants
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
FDA PE N0000182156 Decreased B Lymphocyte Activation
FDA MoA N0000182636 B Lymphocyte Stimulator-directed Antibody Interactions
FDA EPC N0000182637 B Lymphocyte Stimulator-specific Inhibitor

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Systemic lupus erythematosus indication 55464009 DOID:9074

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
Tumor necrosis factor ligand superfamily member 13B Cytokine ANTIBODY BINDING DRUG LABEL DRUG LABEL

External reference:

IDSource
73B0K5S26A UNII
D03068 KEGG_DRUG
4030652 VUID
N0000182640 NUI
4030652 VANDF
C1723401 UMLSCUI
CHEMBL1789843 ChEMBL_ID
DB08879 DRUGBANK_ID
8381 INN_ID
C511911 MESH_SUPPLEMENTAL_RECORD_UI
6887 IUPHAR_LIGAND_ID
1092437 RXNORM
180467 MMSL
27798 MMSL
d07756 MMSL
013666 NDDF
449043000 SNOMEDCT_US
704193005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
BENLYSTA HUMAN PRESCRIPTION DRUG LABEL 1 49401-088 SOLUTION 200 mg SUBCUTANEOUS BLA 29 sections
BENLYSTA HUMAN PRESCRIPTION DRUG LABEL 1 49401-101 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 120 mg INTRAVENOUS BLA 29 sections
BENLYSTA HUMAN PRESCRIPTION DRUG LABEL 1 49401-102 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 400 mg INTRAVENOUS BLA 29 sections