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

Stem definitionDrug idCAS RN
human origin 5246 1350289-85-8

Description:

MoleculeDescription

Synonyms:

  • guselkumab
  • CNTO 1959
  • tremfya
Guselkumab is a human monoclonal IgG1-lambda antibody that selectively binds to the p19 subunit of interleukin 23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Guselkumab inhibits the release of proinflammatory cytokines and chemokines.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
1.79 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Nov. 10, 2017 EMA Janssen-Cilag International N.V.
March 23, 2018 PMDA Janssen Pharmaceutical KK
July 13, 2017 FDA JANSSEN BIOTECH

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 7540.80 22.83 2581 14910 289106 90321850
Accidental exposure to product 2468.39 22.83 707 16784 41659 90569297
Needle issue 1852.17 22.83 448 17043 13486 90597470
Device malfunction 1299.45 22.83 368 17123 20609 90590347
Device issue 1234.04 22.83 382 17109 29155 90581801
Product leakage 1115.05 22.83 199 17292 1209 90609747
Drug delivery system malfunction 948.40 22.83 173 17318 1208 90609748
Device defective 816.48 22.83 178 17313 3308 90607648
Device deployment issue 797.97 22.83 186 17305 4723 90606233
Device leakage 657.61 22.83 184 17307 9807 90601149
Product storage error 556.83 22.83 191 17300 20050 90590906
Syringe issue 387.40 22.83 100 17391 3902 90607054
Drug ineffective 258.87 22.83 712 16779 1383586 89227370
Underdose 258.28 22.83 149 17342 53868 90557088
Inappropriate schedule of product administration 228.17 22.83 206 17285 149727 90461229
Liquid product physical issue 196.11 22.83 48 17443 1502 90609454
COVID-19 183.63 22.83 193 17298 168650 90442306
Psoriasis 155.47 22.83 166 17325 147588 90463368
Therapy interrupted 150.58 22.83 103 17388 50005 90560951
Injection site haemorrhage 109.01 22.83 68 17423 28250 90582706
Device delivery system issue 108.98 22.83 31 17460 1747 90609209
Drug dose omission by device 91.50 22.83 43 17448 10188 90600768
Product quality issue 88.46 22.83 92 17399 79233 90531723
Incorrect dose administered 74.79 22.83 84 17407 78846 90532110
Psoriatic arthropathy 65.00 22.83 139 17352 228196 90382760
Product complaint 63.81 22.83 37 17454 13463 90597493
Injection site reaction 62.82 22.83 83 17408 91997 90518959
Injection site pain 58.02 22.83 113 17378 173586 90437370
Lung adenocarcinoma stage IV 57.25 22.83 14 17477 436 90610520
Pneumonia 57.24 22.83 259 17232 637800 89973156
Therapy cessation 57.23 22.83 51 17440 36310 90574646
Product temperature excursion issue 56.50 22.83 16 17475 887 90610069
Confusional state 56.17 22.83 5 17486 386200 90224756
Breast cancer 55.74 22.83 60 17431 53701 90557255
Paternal exposure during pregnancy 55.64 22.83 13 17478 332 90610624
Product packaging issue 55.05 22.83 18 17473 1623 90609333
Synovitis 51.58 22.83 3 17488 329749 90281207
Incorrect dose administered by device 50.95 22.83 24 17467 5713 90605243
Exposure during pregnancy 49.17 22.83 128 17363 238282 90372674
Wound 43.83 22.83 4 17487 302976 90307980
General physical health deterioration 41.37 22.83 9 17482 355106 90255850
Toxicity to various agents 41.11 22.83 4 17487 287842 90323114
Systemic lupus erythematosus 40.51 22.83 10 17481 361886 90249070
Product label issue 38.04 22.83 12 17479 964 90609992
Surgery 37.84 22.83 45 17446 44842 90566114
Asthenia 37.41 22.83 29 17462 533722 90077234
Dyspnoea 37.30 22.83 71 17420 880884 89730072
Drug delivery system issue 36.54 22.83 8 17483 151 90610805
Device mechanical issue 36.39 22.83 12 17479 1111 90609845
Infusion related reaction 35.60 22.83 18 17473 416762 90194194
Anaemia 35.35 22.83 12 17479 352790 90258166
Drug intolerance 34.41 22.83 22 17469 447569 90163387
Arthropathy 34.11 22.83 14 17477 366228 90244728
Gait disturbance 33.79 22.83 5 17486 260491 90350465
Arthralgia 33.73 22.83 261 17230 778261 89832695
Acute kidney injury 33.69 22.83 10 17481 320377 90290579
Illness 33.22 22.83 58 17433 81911 90529045
Maternal exposure during pregnancy 33.15 22.83 14 17477 360049 90250907
Physical product label issue 33.11 22.83 6 17485 40 90610916
Hypotension 32.72 22.83 11 17480 325386 90285570
Decreased appetite 32.55 22.83 16 17475 376524 90234432
Drug hypersensitivity 31.46 22.83 26 17465 463583 90147373
Intentional product use issue 31.00 22.83 3 17488 216889 90394067
Stomatitis 29.95 22.83 8 17483 274690 90336266
Skin burning sensation 29.85 22.83 27 17464 19584 90591372
Fatigue 28.82 22.83 120 17371 1153903 89457053
Injection related reaction 28.75 22.83 10 17481 1089 90609867
Abdominal discomfort 28.58 22.83 30 17461 477298 90133658
Wrong technique in product usage process 28.17 22.83 50 17441 71521 90539435
Constipation 27.29 22.83 10 17481 280385 90330571
Contraindicated product administered 27.07 22.83 14 17477 320125 90290831
Irritable bowel syndrome 26.86 22.83 4 17487 207444 90403512
Swelling 26.62 22.83 25 17466 419033 90191923
Folliculitis 26.32 22.83 4 17487 204349 90406607
Insomnia 26.16 22.83 16 17475 333458 90277498
Spinal operation 26.06 22.83 19 17472 10177 90600779
Fall 25.90 22.83 33 17458 481777 90129179
Joint swelling 25.51 22.83 36 17455 503264 90107692
Device occlusion 25.33 22.83 18 17473 9264 90601692
Reactive gastropathy 25.32 22.83 8 17483 646 90610310
Impaired healing 25.19 22.83 7 17484 234192 90376764
Drug interaction 25.04 22.83 11 17480 276442 90334514
Musculoskeletal stiffness 25.02 22.83 13 17478 296519 90314437
Product administration error 24.80 22.83 28 17463 26395 90584561
Hypoaesthesia 24.75 22.83 15 17476 314195 90296761
Discomfort 24.71 22.83 11 17480 274324 90336632
Nail psoriasis 24.53 22.83 8 17483 715 90610241
Fibromyalgia 24.47 22.83 5 17486 206264 90404692
Pericarditis 24.07 22.83 11 17480 270140 90340816
Wheezing 24.01 22.83 8 17483 238072 90372884
Oedema peripheral 23.77 22.83 10 17481 257905 90353051
Frostbite 23.54 22.83 6 17485 222 90610734
Oedema 23.46 22.83 5 17486 200290 90410666
Dyspepsia 23.10 22.83 5 17486 198155 90412801
Thrombocytopenia 22.89 22.83 6 17485 208719 90402237
Vomiting 22.87 22.83 77 17414 788216 89822740

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 5954.82 31.00 2003 9604 152362 42457366
Accidental exposure to product 1555.15 31.00 453 11154 19940 42589788
Needle issue 1480.59 31.00 365 11242 8362 42601366
Device deployment issue 983.83 31.00 168 11439 487 42609241
Device issue 828.02 31.00 254 11353 13255 42596473
Product leakage 682.34 31.00 127 11480 675 42609053
Device malfunction 672.10 31.00 212 11395 12115 42597613
Drug delivery system malfunction 606.76 31.00 107 11500 394 42609334
Device defective 510.03 31.00 113 11494 1575 42608153
Product storage error 454.80 31.00 154 11453 10986 42598742
Device leakage 438.89 31.00 147 11460 10138 42599590
Underdose 248.89 31.00 111 11496 16555 42593173
Inappropriate schedule of product administration 238.69 31.00 202 11405 95700 42514028
Drug ineffective 206.67 31.00 496 11111 629701 41980027
Syringe issue 187.93 31.00 75 11532 8481 42601247
Liquid product physical issue 178.81 31.00 42 11565 767 42608961
Psoriasis 134.45 31.00 109 11498 48495 42561233
Product quality issue 98.20 31.00 61 11546 17821 42591907
Psoriatic arthropathy 97.86 31.00 69 11538 24898 42584830
Drug dose omission by device 80.80 31.00 37 11570 5849 42603879
Therapy interrupted 68.10 31.00 53 11554 22197 42587531
Injection site haemorrhage 66.88 31.00 41 11566 11695 42598033
Device delivery system issue 65.50 31.00 20 11587 1017 42608711
Acute kidney injury 62.93 31.00 12 11595 367325 42242403
Arthralgia 54.36 31.00 150 11457 205088 42404640
COVID-19 54.19 31.00 106 11501 115842 42493886
Therapeutic product effect decreased 51.00 31.00 58 11549 39092 42570636
Drug interaction 49.51 31.00 7 11600 266992 42342736
Anaemia 48.28 31.00 9 11598 280269 42329459
Product packaging issue 45.02 31.00 14 11593 757 42608971
Product complaint 44.94 31.00 25 11582 5952 42603776
Therapy cessation 42.52 31.00 39 11568 20411 42589317
Hypotension 40.84 31.00 10 11597 257621 42352107
Delusion of parasitosis 40.35 31.00 9 11598 129 42609599
Neutropenia 37.49 31.00 5 11602 199426 42410302
Incorrect dose administered 37.21 31.00 58 11549 52916 42556812
Device mechanical issue 36.31 31.00 13 11594 1088 42608640
Angioimmunoblastic T-cell lymphoma 36.00 31.00 10 11597 363 42609365
Treatment failure 35.17 31.00 62 11545 62562 42547166
Product temperature excursion issue 33.39 31.00 10 11597 476 42609252
Asthenia 32.58 31.00 18 11589 280775 42328953
Pruritus 31.65 31.00 118 11489 188653 42421075
Nausea 31.62 31.00 37 11570 396762 42212966

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 10185.93 22.78 3289 17462 318493 110250055
Accidental exposure to product 3029.75 22.78 855 19896 49153 110519395
Needle issue 2756.45 22.78 644 20107 17196 110551352
Product leakage 1551.89 22.78 268 20483 1350 110567198
Device issue 1542.26 22.78 467 20284 34068 110534480
Drug delivery system malfunction 1349.65 22.78 223 20528 812 110567736
Device malfunction 1280.96 22.78 378 20373 25180 110543368
Device deployment issue 1091.76 22.78 233 20518 4020 110564528
Product storage error 897.45 22.78 277 20474 21451 110547097
Device defective 877.28 22.78 191 20560 3631 110564917
Device leakage 672.70 22.78 207 20544 15841 110552707
Syringe issue 391.16 22.78 121 20630 9404 110559144
Underdose 332.12 22.78 184 20567 63370 110505178
Inappropriate schedule of product administration 323.32 22.78 283 20468 203354 110365194
Liquid product physical issue 322.98 22.78 72 20679 1528 110567020
Psoriasis 259.91 22.78 213 20538 139780 110428768
COVID-19 220.29 22.78 250 20501 244810 110323738
Therapy interrupted 198.48 22.78 121 20630 49701 110518847
Injection site haemorrhage 165.27 22.78 93 20658 32935 110535613
Product quality issue 142.02 22.78 117 20634 77182 110491366
Product complaint 100.09 22.78 50 20701 13922 110554626
Drug ineffective 91.41 22.78 540 20211 1520000 109048548
Pneumonia 90.57 22.78 364 20387 876350 109692198
Psoriatic arthropathy 87.83 22.78 143 20608 196618 110371930
Product packaging issue 84.80 22.78 25 20726 1646 110566902
Incorrect dose administered 78.47 22.78 97 20654 103544 110465004
Toxicity to various agents 73.89 22.78 4 20747 480551 110087997
Injection site pain 73.61 22.78 125 20626 177797 110390751
Acute kidney injury 73.40 22.78 15 20736 635415 109933133
Therapy cessation 72.30 22.78 63 20688 44794 110523754
Hypotension 63.39 22.78 11 20740 523838 110044710
Confusional state 63.39 22.78 7 20744 468673 110099875
Anaemia 60.95 22.78 14 20737 547072 110021476
Product temperature excursion issue 57.88 22.78 16 20735 835 110567713
Drug interaction 51.50 22.78 15 20736 500168 110068380
Incorrect dose administered by device 50.62 22.78 25 20726 6789 110561759
Asthenia 50.09 22.78 34 20717 688965 109879583
Drug intolerance 48.15 22.78 9 20742 406503 110162045
Dyspnoea 48.03 22.78 84 20667 1106788 109461760
Lung adenocarcinoma stage IV 44.73 22.78 12 20739 559 110567989
Illness 44.00 22.78 65 20686 82106 110486442
General physical health deterioration 41.54 22.78 14 20737 425281 110143267
Neutropenia 40.88 22.78 10 20741 374610 110193938
Decreased appetite 38.01 22.78 21 20730 475825 110092723
Drug delivery system issue 37.97 22.78 9 20742 252 110568296
Physical product label issue 37.93 22.78 7 20744 54 110568494
Delusion of parasitosis 37.77 22.78 9 20742 258 110568290
Breast cancer 37.40 22.78 41 20710 38501 110530047
Synovitis 37.27 22.78 4 20747 274088 110294460
Arthralgia 36.13 22.78 260 20491 779372 109789176
Wrong technique in product usage process 35.60 22.78 61 20690 87287 110481261
Poor quality product administered 34.39 22.78 17 20734 4624 110563924
Stomatitis 34.18 22.78 5 20746 270237 110298311
Angioimmunoblastic T-cell lymphoma 34.13 22.78 10 20741 644 110567904
Product label issue 33.78 22.78 11 20740 1007 110567541
Vomiting 33.52 22.78 76 20675 910599 109657949
Mobility decreased 33.50 22.78 3 20748 237419 110331129
Surgery 33.44 22.78 40 20711 41243 110527305
Spinal operation 32.19 22.78 22 20729 10950 110557598
Device mechanical issue 29.82 22.78 12 20739 2012 110566536
Completed suicide 29.48 22.78 5 20746 242376 110326172
Nausea 29.29 22.78 126 20625 1235564 109332984
Contraindicated product administered 28.33 22.78 6 20745 248261 110320287
Intentional product use issue 28.27 22.78 6 20745 247900 110320648
Overdose 28.05 22.78 5 20746 233789 110334759
Drug hypersensitivity 27.26 22.78 27 20724 454063 110114485
Insomnia 27.24 22.78 17 20734 360573 110207975
Product administration error 26.82 22.78 34 20717 37183 110531365
Off label use 26.46 22.78 411 20340 1499774 109068774
Oedema 26.28 22.78 4 20747 209972 110358576
Device delivery system issue 25.85 22.78 11 20740 2122 110566426
Gait disturbance 25.72 22.78 10 20741 278198 110290350
Wheezing 25.61 22.78 8 20743 255222 110313326
Systemic lupus erythematosus 25.47 22.78 8 20743 254330 110314218
Infusion related reaction 24.85 22.78 21 20730 381141 110187407
Wrong schedule 24.79 22.78 8 20743 712 110567836
Product dispensing error 24.42 22.78 22 20729 16323 110552225
Blood cholesterol increased 24.36 22.78 3 20748 184782 110383766
Product packaging quantity issue 24.23 22.78 10 20741 1789 110566759
Wound 24.16 22.78 7 20744 234430 110334118
Pancytopenia 24.05 22.78 5 20746 209608 110358940
Hypokalaemia 23.95 22.78 3 20748 182445 110386103
Pustule 23.51 22.78 12 20739 3492 110565056
Cellulitis 23.41 22.78 64 20687 125952 110442596
Dermatitis exfoliative generalised 23.09 22.78 18 20733 10954 110557594
Drug abuse 23.09 22.78 3 20748 177408 110391140
Dyspepsia 23.09 22.78 4 20747 190961 110377587
Thrombocytopenia 23.01 22.78 19 20732 348866 110219682
Respiratory failure 22.99 22.78 6 20745 215326 110353222
Tachycardia 22.93 22.78 7 20744 226638 110341910
Pyrexia 22.87 22.78 89 20662 898176 109670372
Oedema peripheral 22.81 22.78 17 20734 328643 110239905

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AC16 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Interleukin inhibitors
FDA MoA N0000192798 Interleukin-23 Antagonists
FDA EPC N0000192799 Interleukin-23 Antagonist
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:67079 anti-inflammatory agent

Related Drugs by ATC class:

L04AC Interleukin inhibitors 18 drugs
anakinrabasiliximabbimekizumabbrodalumabcanakinumabdaclizumabixekizumabmirikizumabrilonaceptrisankizumabsarilumabsatralizumab show all 18 →

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

DiseaseRelationSNOMED_IDDOID
Palmoplantar pustulosis indication 27520001 DOID:4398
Plaque psoriasis indication 200965009




🐶 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-23 Cytokine ANTIBODY BINDING UNKNOWN DRUG LABEL

External reference:

IDSource
089658A12D UNII
4036845 VANDF
C3852217 UMLSCUI
CHEBI:754996 CHEBI
CHEMBL2364648 ChEMBL_ID
DB11834 DRUGBANK_ID
D10438 KEGG_DRUG
9774 INN_ID
C000588857 MESH_SUPPLEMENTAL_RECORD_UI
7998 IUPHAR_LIGAND_ID
736494008 SNOMEDCT_US
763578000 SNOMEDCT_US
259984 MMSL
32911 MMSL
d08615 MMSL
017278 NDDF
1928588 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
TREMFYA HUMAN PRESCRIPTION DRUG LABEL 1 57894-640 INJECTION 100 mg SUBCUTANEOUS BLA 31 sections
TREMFYA HUMAN PRESCRIPTION DRUG LABEL 1 57894-640 INJECTION 100 mg SUBCUTANEOUS BLA 31 sections
TREMFYA HUMAN PRESCRIPTION DRUG LABEL 1 57894-650 INJECTION 200 mg INTRAVENOUS BLA 31 sections
TREMFYA HUMAN PRESCRIPTION DRUG LABEL 1 57894-650 INJECTION 200 mg INTRAVENOUS BLA 31 sections
TREMFYA HUMAN PRESCRIPTION DRUG LABEL 1 57894-651 INJECTION 200 mg SUBCUTANEOUS BLA 31 sections
TREMFYA HUMAN PRESCRIPTION DRUG LABEL 1 57894-651 INJECTION 200 mg SUBCUTANEOUS BLA 31 sections