belimumab 🐶 Veterinary Use | 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
July 13, 2011 EMA Glaxo Group Ltd.
March 9, 2011 FDA HUMAN GENOME SCIENCES INC.
Sept. 27, 2017 PMDA GlaxoSmithKline KK

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
Lupus nephritis 312.64 16.61 80 13274 2759 63472909
Therapy interrupted 269.37 16.61 133 13221 32322 63443346
Product dose omission issue 262.99 16.61 283 13071 234030 63241638
Product complaint 194.19 16.61 80 13274 12729 63462939
Exposure via skin contact 187.87 16.61 37 13317 368 63475300
Wrong technique in device usage process 160.38 16.61 50 13304 3548 63472120
SLE arthritis 141.27 16.61 32 13322 649 63475019
Therapy cessation 138.81 16.61 84 13270 30373 63445295
COVID-19 93.49 16.61 117 13237 112986 63362682
Product storage error 77.94 16.61 45 13309 14911 63460757
Proteinuria 75.05 16.61 48 13306 19097 63456571
Systemic lupus erythematosus rash 74.65 16.61 25 13329 2227 63473441
Exposure during pregnancy 68.96 16.61 120 13234 155427 63320241
Accidental exposure to product 66.03 16.61 51 13303 27354 63448314
Coombs positive haemolytic anaemia 63.97 16.61 15 13339 356 63475312
Leukopenia 62.30 16.61 79 13275 77211 63398457
Antinuclear antibody negative 59.55 16.61 13 13341 221 63475447
Pleuritic pain 58.03 16.61 30 13324 7999 63467669
Product availability issue 56.59 16.61 24 13330 4097 63471571
Circumstance or information capable of leading to medication error 54.68 16.61 23 13331 3847 63471821
Social problem 51.84 16.61 15 13339 823 63474845
Lupus pneumonitis 49.70 16.61 9 13345 54 63475614
Central nervous system lupus 49.38 16.61 13 13341 501 63475167
Rhesus antigen positive 48.75 16.61 10 13344 124 63475544
Antiphospholipid syndrome 48.16 16.61 17 13337 1773 63473895
Surgery 46.53 16.61 47 13307 35865 63439803
Renal vascular thrombosis 44.47 16.61 8 13346 46 63475622
Herpes simplex reactivation 43.44 16.61 12 13342 556 63475112
Urinary tract infection 43.20 16.61 138 13216 264546 63211122
Hospitalisation 42.11 16.61 69 13285 85012 63390656
Cutaneous lupus erythematosus 41.29 16.61 17 13337 2695 63472973
Malaise 36.95 16.61 179 13175 415775 63059893
Vasculitis 35.61 16.61 30 13324 18179 63457489
Gastritis haemorrhagic 35.29 16.61 13 13341 1532 63474136
Contraindicated product administered 34.67 16.61 3 13351 217645 63258023
Pyrexia 34.54 16.61 192 13162 470286 63005382
Parotid gland enlargement 34.40 16.61 11 13343 847 63474821
Drug interaction 34.31 16.61 4 13350 229127 63246541
Toxicity to various agents 33.13 16.61 6 13348 247244 63228424
Chills 31.49 16.61 72 13282 113306 63362362
Abortion spontaneous 31.48 16.61 44 13310 47151 63428517
Headache 31.44 16.61 234 13120 633007 62842661
Herpes zoster 30.64 16.61 59 13295 82403 63393265
Complex regional pain syndrome 29.97 16.61 13 13341 2344 63473324
Blood albumin increased 29.14 16.61 10 13344 959 63474709
Blood immunoglobulin M decreased 28.95 16.61 10 13344 978 63474690
Hyperparathyroidism secondary 28.62 16.61 11 13343 1456 63474212
Serositis 28.18 16.61 9 13345 690 63474978
Confusional state 27.17 16.61 8 13346 236372 63239296
Underdose 26.89 16.61 31 13323 27425 63448243
Immunoglobulins decreased 26.33 16.61 10 13344 1282 63474386
Blood immunoglobulin G decreased 26.26 16.61 12 13342 2446 63473222
Triple negative breast cancer 25.52 16.61 6 13348 144 63475524
Drug intolerance 25.23 16.61 17 13337 308644 63167024
Ophthalmic herpes zoster 24.95 16.61 11 13343 2062 63473606
Arthralgia 24.10 16.61 203 13151 569507 62906161
Complement factor decreased 24.08 16.61 5 13349 66 63475602
Lymphopenia 23.76 16.61 24 13330 18303 63457365
Haemorrhagic cyst 23.75 16.61 6 13348 196 63475472
Herpes zoster meningitis 23.43 16.61 5 13349 76 63475592
Anxiety disorder 23.29 16.61 13 13341 4037 63471631
Injection site rash 23.24 16.61 24 13330 18785 63456883
Skin disorder 21.94 16.61 29 13325 29478 63446190
Illness 21.89 16.61 38 13316 49021 63426647
Disseminated varicella zoster virus infection 21.87 16.61 6 13348 271 63475397
Cytomegalovirus enteritis 21.57 16.61 6 13348 285 63475383
Type 1 diabetes mellitus 21.34 16.61 12 13342 3778 63471890
Inappropriate schedule of product administration 20.49 16.61 58 13296 103907 63371761
Depression 19.92 16.61 88 13266 196404 63279264
Pneumocystis jirovecii pneumonia 19.85 16.61 21 13333 16893 63458775
Erysipelas 19.66 16.61 15 13339 7890 63467778
Osteonecrosis 19.63 16.61 25 13329 24505 63451163
General physical health deterioration 19.46 16.61 9 13345 201393 63274275
Female reproductive tract disorder 19.26 16.61 6 13348 424 63475244
Heat stroke 18.87 16.61 7 13347 841 63474827
Mean cell haemoglobin increased 18.44 16.61 10 13344 2933 63472735
Protein urine present 18.35 16.61 13 13341 6107 63469561
Intentional dose omission 17.24 16.61 14 13340 8061 63467607
Acute kidney injury 17.22 16.61 18 13336 263397 63212271
Acarodermatitis 17.21 16.61 7 13347 1076 63474592
Nephrotic syndrome 17.08 16.61 12 13342 5564 63470104
Influenza 17.06 16.61 56 13298 108666 63367002
Appendicitis 17.00 16.61 14 13340 8215 63467453
Pneumonia 16.82 16.61 158 13196 456609 63019059

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
Progressive multifocal leukoencephalopathy 63.85 37.88 18 681 9746 34946486
T-lymphocyte count decreased 44.87 37.88 7 692 206 34956026

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
Lupus nephritis 248.03 17.71 61 10234 2947 79731146
Therapy interrupted 248.00 17.71 107 10188 31234 79702859
Product dose omission issue 198.28 17.71 199 10096 247338 79486755
Therapy cessation 108.74 17.71 65 10230 37497 79696596
Exposure via skin contact 84.92 17.71 17 10278 312 79733781
COVID-19 83.07 17.71 102 10193 157572 79576521
Wrong technique in device usage process 68.51 17.71 24 10271 4004 79730089
Product complaint 63.26 17.71 32 10263 13317 79720776
Exposure during pregnancy 62.45 17.71 71 10224 101061 79633032
Product storage error 60.12 17.71 33 10262 16193 79717900
Proteinuria 59.01 17.71 42 10253 32460 79701633
Rhesus antigen positive 53.62 17.71 10 10285 124 79733969
Product availability issue 50.28 17.71 19 10276 3928 79730165
Progressive multifocal leukoencephalopathy 45.39 17.71 30 10265 20570 79713523
Urinary tract infection 42.55 17.71 103 10192 274409 79459684
Herpes zoster 40.76 17.71 55 10240 93028 79641065
Renal vascular thrombosis 38.91 17.71 7 10288 70 79734023
Social problem 38.22 17.71 12 10283 1426 79732667
Headache 38.16 17.71 176 10119 653596 79080497
Abortion spontaneous 37.84 17.71 31 10264 29476 79704617
Circumstance or information capable of leading to medication error 36.25 17.71 15 10280 3933 79730160
Toxicity to various agents 35.31 17.71 6 10289 421534 79312559
Surgery 35.01 17.71 31 10264 32735 79701358
Drug interaction 34.57 17.71 6 10289 415177 79318916
Hospitalisation 31.50 17.71 49 10246 94187 79639906
Systemic lupus erythematosus 31.15 17.71 56 10239 121093 79613000
Blood immunoglobulin M decreased 30.98 17.71 10 10285 1299 79732794
Pleuritic pain 30.48 17.71 18 10277 10134 79723959
Arthralgia 30.46 17.71 150 10145 571653 79162440
Blood albumin increased 29.67 17.71 10 10285 1485 79732608
Triple negative breast cancer 29.67 17.71 6 10289 116 79733977
Immunoglobulins decreased 29.26 17.71 10 10285 1550 79732543
Malaise 28.60 17.71 132 10163 489737 79244356
Blood immunoglobulin G decreased 28.11 17.71 12 10283 3397 79730696
Hyperparathyroidism secondary 27.48 17.71 11 10284 2649 79731444
Vasculitis 27.32 17.71 24 10271 25078 79709015
JC virus infection 26.62 17.71 12 10283 3869 79730224
Accidental exposure to product 26.45 17.71 26 10269 31296 79702797
Serositis 26.35 17.71 8 10287 850 79733243
Acute kidney injury 25.50 17.71 18 10277 519386 79214707
Lupus pneumonitis 25.39 17.71 5 10290 84 79734009
Leukopenia 25.16 17.71 50 10245 116463 79617630
T-lymphocyte count decreased 25.00 17.71 7 10288 560 79733533
Bulbar palsy 24.84 17.71 6 10289 268 79733825
Female reproductive tract disorder 24.40 17.71 6 10289 289 79733804
Haemorrhagic cyst 24.16 17.71 6 10289 301 79733792
Ophthalmic herpes zoster 23.98 17.71 10 10285 2674 79731419
Pneumonia 23.77 17.71 156 10139 660090 79074003
Influenza 23.76 17.71 52 10243 129554 79604539
Injection site rash 23.30 17.71 19 10276 17935 79716158
Cutaneous lupus erythematosus 22.89 17.71 10 10285 2993 79731100
Chills 22.55 17.71 58 10237 160176 79573917
Acarodermatitis 22.52 17.71 8 10287 1390 79732703
Pyrexia 22.42 17.71 157 10138 678552 79055541
Migraine 21.92 17.71 40 10255 87453 79646640
Confusional state 21.73 17.71 7 10288 317990 79416103
Herpes zoster meningitis 21.64 17.71 5 10290 184 79733909
Type 1 diabetes mellitus 20.07 17.71 12 10283 6907 79727186
Premature rupture of membranes 19.99 17.71 10 10285 4059 79730034
Underdose 19.97 17.71 23 10272 33128 79700965
Disseminated varicella zoster virus infection 19.86 17.71 6 10289 627 79733466
Mean cell haemoglobin increased 19.50 17.71 10 10285 4275 79729818
Insurance issue 19.43 17.71 11 10284 5722 79728371
Knee operation 19.20 17.71 11 10284 5855 79728238
Hysterectomy 18.51 17.71 11 10284 6261 79727832
Cytomegalovirus enteritis 18.38 17.71 6 10289 808 79733285
Hypnotherapy 18.03 17.71 3 10292 18 79734075
Parophthalmia 17.96 17.71 5 10290 392 79733701

FDA Adverse Event Reporting System (Pediatric)

None

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