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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

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
Product dose omission issue 1131.48 17.18 708 17363 290979 90319397
Product complaint 521.64 17.18 166 17905 13334 90597042
Wrong technique in device usage process 447.19 17.18 122 17949 5713 90604663
Therapy interrupted 398.33 17.18 196 17875 49912 90560464
Lupus nephritis 398.25 17.18 107 17964 4725 90605651
Exposure via skin contact 194.22 17.18 75 17996 10630 90599746
Product storage error 190.55 17.18 89 17982 20152 90590224
Therapy cessation 180.50 17.18 104 17967 36257 90574119
Accidental exposure to product 158.29 17.18 101 17970 42265 90568111
Proteinuria 141.22 17.18 76 17995 23215 90587161
COVID-19 141.09 17.18 171 17900 168672 90441704
SLE arthritis 130.56 17.18 30 18041 687 90609689
Leukopenia 84.04 17.18 102 17969 100608 90509768
Off label use 81.68 17.18 433 17638 1101819 89508557
Systemic lupus erythematosus rash 78.49 17.18 26 18045 2363 90608013
Exposure during pregnancy 78.44 17.18 157 17914 238253 90372123
Coombs positive haemolytic anaemia 76.00 17.18 18 18053 472 90609904
Antinuclear antibody negative 74.25 17.18 16 18055 270 90610106
Pleuritic pain 71.52 17.18 37 18034 10424 90599952
Vasculitis 67.58 17.18 47 18024 22646 90587730
Urinary tract infection 65.67 17.18 170 17901 305462 90304914
Herpes zoster 63.43 17.18 86 17985 94558 90515818
Incorrect dose administered 62.69 17.18 78 17993 78852 90531524
Antiphospholipid syndrome 60.01 17.18 21 18050 2253 90608123
Surgery 59.41 17.18 58 18013 44829 90565547
Nephrotic syndrome 59.09 17.18 29 18042 7310 90603066
Hospitalisation 52.85 17.18 93 17978 128007 90482369
Disseminated varicella zoster virus infection 51.39 17.18 13 18058 451 90609925
Herpes simplex reactivation 49.74 17.18 15 18056 1004 90609372
Rhesus antigen positive 49.28 17.18 10 18061 124 90610252
Injection site haemorrhage 47.96 17.18 42 18029 28276 90582100
Hypocomplementaemia 47.33 17.18 11 18060 265 90610111
Drug ineffective 47.32 17.18 451 17620 1383847 89226529
Confusional state 46.72 17.18 10 18061 386195 90224181
Lupus pneumonitis 45.59 17.18 9 18062 96 90610280
Gastritis haemorrhagic 45.12 17.18 16 18055 1784 90608592
Cutaneous lupus erythematosus 43.21 17.18 18 18053 3100 90607276
Intentional dose omission 41.97 17.18 32 18039 17751 90592625
Central nervous system lupus 41.46 17.18 14 18057 1349 90609027
Hyperparathyroidism secondary 41.35 17.18 15 18056 1786 90608590
Renal vascular thrombosis 41.28 17.18 8 18063 77 90610299
Abortion spontaneous 40.66 17.18 52 18019 54004 90556372
Device use error 39.44 17.18 22 18049 7199 90603177
Contraindicated product administered 39.31 17.18 8 18063 320131 90290245
Complex regional pain syndrome 39.05 17.18 16 18055 2643 90607733
Immunoglobulins decreased 39.05 17.18 14 18057 1612 90608764
Pneumocystis jirovecii pneumonia 38.51 17.18 33 18038 21583 90588793
Illness 38.41 17.18 63 18008 81906 90528470
Toxicity to various agents 37.92 17.18 6 18065 287840 90322536
General physical health deterioration 37.60 17.18 12 18059 355103 90255273
Injection site pain 36.61 17.18 96 17975 173603 90436773
Malaise 34.46 17.18 217 17854 585769 90024607
Arthropathy 34.38 17.18 15 18056 366227 90244149
Parotid gland enlargement 33.95 17.18 11 18060 932 90609444
Urine protein/creatinine ratio increased 33.19 17.18 11 18060 1001 90609375
Neutrophil count 33.01 17.18 9 18062 419 90609957
Drug ineffective for unapproved indication 32.28 17.18 52 18019 66592 90543784
Drug interaction 31.74 17.18 8 18063 276445 90333931
Suicidal ideation 30.93 17.18 54 18017 73801 90536575
Impaired healing 30.58 17.18 5 18066 234194 90376182
Progressive multifocal leukoencephalopathy 30.15 17.18 25 18046 15630 90594746
Anxiety disorder 29.65 17.18 16 18055 4906 90605470
Lymphopenia 29.21 17.18 29 18042 22852 90587524
Complement factor decreased 28.76 17.18 6 18065 86 90610290
Cerebrospinal fluid leakage 28.49 17.18 11 18060 1556 90608820
Blood albumin increased 27.69 17.18 10 18061 1175 90609201
Depression 27.67 17.18 126 17945 300475 90309901
Osteonecrosis 27.64 17.18 30 18041 26211 90584165
Product prescribing issue 27.27 17.18 18 18053 7961 90602415
Synovitis 27.21 17.18 16 18055 329736 90280640
Wheezing 27.12 17.18 7 18064 238073 90372303
Chills 26.84 17.18 72 17999 131909 90478467
Drug intolerance 26.64 17.18 30 18041 447561 90162815
Penicillium infection 26.42 17.18 7 18064 292 90610084
Dyspepsia 26.39 17.18 4 18067 198156 90412220
Headache 26.33 17.18 275 17796 862471 89747905
Blood immunoglobulin M decreased 26.23 17.18 10 18061 1367 90609009
Wound 26.00 17.18 14 18057 302966 90307410
Blood cholesterol increased 25.94 17.18 5 18066 208007 90402369
Pyrexia 24.29 17.18 219 17852 660266 89950110
Serositis 23.07 17.18 9 18062 1308 90609068
Hepatic enzyme increased 22.77 17.18 23 18048 360713 90249663
Blood immunoglobulin G decreased 22.72 17.18 12 18059 3526 90606850
Injection site rash 22.65 17.18 26 18045 24147 90586229
Ophthalmic herpes zoster 22.39 17.18 11 18060 2777 90607599
Abdominal discomfort 22.38 17.18 38 18033 477290 90133086
Product distribution issue 22.19 17.18 12 18059 3693 90606683
Haemorrhagic cyst 22.16 17.18 6 18065 272 90610104
Injury 22.10 17.18 6 18065 197343 90413033
Irritable bowel syndrome 21.96 17.18 7 18064 207441 90402935
Osteoarthritis 21.82 17.18 6 18065 195724 90414652
Discontinued product administered 21.78 17.18 5 18066 114 90610262
Disseminated cytomegaloviral infection 21.69 17.18 6 18065 295 90610081
Injection site bruising 21.58 17.18 38 18033 52269 90558107
Circumstance or information capable of leading to medication error 21.46 17.18 13 18058 4954 90605422
Symptom recurrence 21.45 17.18 12 18059 3947 90606429
Product availability issue 21.26 17.18 15 18056 7389 90602987
Polyarthritis 21.13 17.18 22 18049 18328 90592048
Skin disorder 21.08 17.18 31 18040 36675 90573701
Erysipelas 20.72 17.18 16 18055 9036 90601340
Cytomegalovirus enteritis 20.43 17.18 6 18065 366 90610010
Insurance issue 20.07 17.18 17 18054 10941 90599435
Triple negative breast cancer 19.95 17.18 6 18065 398 90609978
Lip swelling 19.90 17.18 31 18040 38579 90571797
Protein urine present 19.71 17.18 14 18057 6970 90603406
Head discomfort 19.57 17.18 20 18051 16313 90594063
Arthralgia 19.57 17.18 239 17832 778283 89832093
Tooth extraction 19.34 17.18 17 18054 11496 90598880
Type 1 diabetes mellitus 19.28 17.18 12 18059 4800 90605576
Rib fracture 19.20 17.18 25 18046 26410 90583966
Neuropsychiatric lupus 18.93 17.18 5 18066 206 90610170
Heat stroke 18.80 17.18 7 18064 897 90609479
Peritonitis 18.14 17.18 21 18050 19684 90590692
Kidney infection 18.03 17.18 24 18047 25892 90584484
Superinfection bacterial 17.96 17.18 7 18064 1015 90609361
Lupus enteritis 17.87 17.18 4 18067 81 90610295
Premature rupture of membranes 17.70 17.18 12 18059 5546 90604830
Myasthenia gravis crisis 17.69 17.18 7 18064 1057 90609319
Acute kidney injury 17.43 17.18 23 18048 320364 90290012
Female reproductive tract disorder 17.27 17.18 6 18065 630 90609746

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
Product dose omission issue 102.28 37.71 61 1215 154304 42465755
Progressive multifocal leukoencephalopathy 65.78 37.71 21 1255 11515 42608544
Meningitis meningococcal 63.39 37.71 9 1267 88 42619971
Off label use 42.38 37.71 71 1205 638264 41981795
T-lymphocyte count decreased 39.90 37.71 7 1269 282 42619777

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
Product dose omission issue 656.17 17.51 442 13634 321340 110253883
Therapy interrupted 306.44 17.51 142 13934 49680 110525543
Lupus nephritis 274.53 17.51 72 14004 4573 110570650
Product complaint 207.60 17.51 75 14001 13897 110561326
Wrong technique in device usage process 177.67 17.51 56 14020 6845 110568378
COVID-19 123.64 17.51 154 13922 244906 110330317
Proteinuria 121.31 17.51 71 14005 39947 110535276
Therapy cessation 103.84 17.51 67 14009 44790 110530433
Product storage error 94.70 17.51 49 14027 21679 110553544
Herpes zoster 78.12 17.51 82 13994 108297 110466926
Progressive multifocal leukoencephalopathy 77.53 17.51 45 14031 24911 110550312
Exposure via skin contact 73.13 17.51 35 14041 13112 110562111
Exposure during pregnancy 62.59 17.51 91 13985 167333 110407890
Urinary tract infection 62.47 17.51 132 13944 326150 110249073
Accidental exposure to product 61.57 17.51 51 14025 49957 110525266
Systemic lupus erythematosus 57.14 17.51 110 13966 254228 110320995
Hypocomplementaemia 55.66 17.51 12 14064 325 110574898
Rhesus antigen positive 53.76 17.51 10 14066 124 110575099
Abortion spontaneous 50.83 17.51 39 14037 34243 110540980
Meningitis meningococcal 48.90 17.51 10 14066 208 110575015
Pleuritic pain 44.63 17.51 27 14049 16113 110559110
Leukopenia 44.54 17.51 73 14003 148718 110426505
Disseminated varicella zoster virus infection 44.09 17.51 13 14063 1268 110573955
Immunoglobulins decreased 43.73 17.51 15 14061 2384 110572839
Treatment failure 42.79 17.51 103 13973 277131 110298092
Toxicity to various agents 41.34 17.51 6 14070 480549 110094674
Hyperparathyroidism secondary 39.04 17.51 15 14061 3289 110571934
Surgery 38.57 17.51 36 14040 41247 110533976
Neutrophil count 37.49 17.51 9 14067 397 110574826
Renal vascular thrombosis 35.97 17.51 7 14069 112 110575111
Drug interaction 35.26 17.51 10 14066 500173 110075050
Hospitalisation 34.91 17.51 64 14012 142429 110432794
Antinuclear antibody negative 34.21 17.51 7 14069 146 110575077
Confusional state 33.72 17.51 9 14067 468671 110106552
Urine protein/creatinine ratio increased 33.27 17.51 11 14065 1562 110573661
JC virus infection 32.23 17.51 15 14061 5275 110569948
Polyarthritis 29.05 17.51 22 14054 18941 110556282
Antiphospholipid syndrome 28.20 17.51 11 14065 2512 110572711
Bulbar palsy 28.15 17.51 7 14069 358 110574865
Cutaneous lupus erythematosus 28.01 17.51 12 14064 3476 110571747
Intentional dose omission 27.93 17.51 22 14054 20058 110555165
Blood albumin increased 27.31 17.51 10 14066 1921 110573302
Drug ineffective 26.79 17.51 303 13773 1520237 109054986
Blood immunoglobulin M decreased 26.77 17.51 10 14066 2031 110573192
Suicidal ideation 26.64 17.51 45 14031 93892 110481331
Acute kidney injury 26.64 17.51 25 14051 635405 109939818
Condition aggravated 26.53 17.51 172 13904 734664 109840559
Drug ineffective for unapproved indication 26.21 17.51 47 14029 102791 110472432
Incorrect dose administered 25.95 17.51 47 14029 103594 110471629
General physical health deterioration 25.67 17.51 11 14065 425284 110149939
Product distribution issue 25.48 17.51 12 14064 4334 110570889
Serositis 25.48 17.51 9 14067 1560 110573663
Injection site pain 25.20 17.51 64 14012 177858 110397365
Ophthalmic herpes zoster 25.04 17.51 11 14065 3384 110571839
Vaccination failure 24.78 17.51 10 14066 2496 110572727
Lymphopenia 24.74 17.51 28 14048 40142 110535081
Premature rupture of membranes 24.74 17.51 12 14064 4625 110570598
Product prescribing issue 24.54 17.51 17 14059 12755 110562468
T-lymphocyte count decreased 24.41 17.51 7 14069 619 110574604
Penicillium infection 24.14 17.51 7 14069 644 110574579
Headache 24.04 17.51 193 13883 882184 109693039
Malaise 23.48 17.51 156 13920 671663 109903560
Lupus pneumonitis 23.38 17.51 5 14071 130 110575093
Arthralgia 23.15 17.51 174 13902 779458 109795765
Blood immunoglobulin G decreased 23.01 17.51 12 14064 5388 110569835
Haemorrhagic cyst 22.58 17.51 6 14070 400 110574823
Coombs positive haemolytic anaemia 21.69 17.51 8 14068 1569 110573654
Rib fracture 21.59 17.51 24 14052 33746 110541477
Female reproductive tract disorder 21.32 17.51 6 14070 496 110574727
Off label use 21.23 17.51 287 13789 1499898 109075325
Injection site rash 21.06 17.51 20 14056 23399 110551824
Triple negative breast cancer 20.97 17.51 6 14070 526 110574697
Vasculitis 20.41 17.51 24 14052 35849 110539374
Injection site haemorrhage 20.31 17.51 23 14053 33005 110542218
Insurance issue 20.09 17.51 14 14062 10598 110564625
Influenza 20.08 17.51 57 14019 169044 110406179
Disseminated cytomegaloviral infection 19.99 17.51 6 14070 622 110574601
Acarodermatitis 19.91 17.51 8 14068 1973 110573250
Lupus enteritis 19.66 17.51 4 14072 81 110575142
Brain stem syndrome 19.18 17.51 7 14069 1332 110573891
Progressive bulbar palsy 19.10 17.51 4 14072 94 110575129
Post herpetic neuralgia 19.00 17.51 9 14067 3292 110571931
Pneumonia 18.80 17.51 182 13894 876532 109698691
Migraine 18.60 17.51 56 14020 171596 110403627
Osteonecrosis 18.25 17.51 22 14054 33719 110541504
Hypnotherapy 18.07 17.51 3 14073 18 110575205
Kidney infection 17.77 17.51 19 14057 25580 110549643
Chills 17.74 17.51 59 14017 190521 110384702
Tooth extraction 17.57 17.51 14 14062 12977 110562246

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AG04 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Monoclonal antibodies
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
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:76595 nephroprotective agent
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

L04AG Monoclonal antibodies 14 drugs
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Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Systemic lupus erythematosus indication 55464009 DOID:9074




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

External reference:

IDSource
D03068 KEGG_DRUG
4030652 VUID
N0000182640 NUI
4030652 VANDF
CHEBI:750192 CHEBI
CHEMBL1789843 ChEMBL_ID
C511911 MESH_SUPPLEMENTAL_RECORD_UI
6887 IUPHAR_LIGAND_ID
DB08879 DRUGBANK_ID
1092437 RXNORM
180467 MMSL
27798 MMSL
d07756 MMSL
013666 NDDF
449043000 SNOMEDCT_US
704193005 SNOMEDCT_US
C1723401 UMLSCUI
8381 INN_ID
73B0K5S26A UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
BENLYSTA HUMAN PRESCRIPTION DRUG LABEL 1 49401-088 SOLUTION 200 mg SUBCUTANEOUS BLA 30 sections
BENLYSTA HUMAN PRESCRIPTION DRUG LABEL 1 49401-101 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 120 mg INTRAVENOUS BLA 30 sections
BENLYSTA HUMAN PRESCRIPTION DRUG LABEL 1 49401-102 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 400 mg INTRAVENOUS BLA 30 sections