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

Stem definitionDrug idCAS RN
humanized origin 5362 909395-70-6

Description:

MoleculeDescription

Synonyms:

  • romosozumab
  • romosozumab-aqqg
  • evenity
  • AMG 785
  • AMG-785
  • anti-sclerostin monoclonal antibody
  • CDP-7851
  • sclerostin Ab
Romosozumab-aqqg is a humanized monoclonal antibody (IgG2) produced in a mammalian cell line (Chinese Hamster Ovary) by recombinant DNA technology that binds to and inhibits the action of sclerostin, a regulatory factor in bone metabolism. Romosozumab increases bone formation and, to a lesser extent, decreases bone resorption. Animal studies showed that romosozumab-aqqg stimulates new bone formation on trabecular and cortical bone surfaces by stimulating osteoblastic activity resulting in increases in trabecular and cortical bone mass and improvements in bone structure and strength.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
7 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Aug. 1, 2019 PMDA AMGEN ASTELLAS BIOPHARMA K.K.
April 9, 2019 FDA AMGEN INC
Dec. 9, 2019 EMA UCB PHARMA S.A.

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
Fall 669.15 23.35 539 11849 481271 90134788
Fracture 523.53 23.35 171 12217 21905 90594154
Femur fracture 410.89 23.35 174 12214 45908 90570151
Spinal fracture 409.07 23.35 142 12246 21874 90594185
Injection site pain 371.51 23.35 253 12135 173446 90442613
Spinal compression fracture 333.30 23.35 111 12277 15067 90600992
Compression fracture 287.07 23.35 87 12301 8702 90607357
Femoral neck fracture 286.50 23.35 90 12298 10143 90605916
Bone density decreased 265.74 23.35 97 12291 17248 90598811
Injection site erythema 255.34 23.35 162 12226 98340 90517719
Injection site swelling 255.14 23.35 136 12252 59703 90556356
Transient ischaemic attack 177.98 23.35 96 12292 43080 90572979
Thoracic vertebral fracture 177.93 23.35 54 12334 5420 90610639
Cardiac failure 175.27 23.35 134 12254 109362 90506697
Bone pain 168.15 23.35 105 12283 61878 90554181
Myocardial infarction 155.07 23.35 123 12265 105849 90510210
Cerebral infarction 149.81 23.35 73 12315 26523 90589536
Radius fracture 149.22 23.35 44 12344 4000 90612059
Lumbar vertebral fracture 130.33 23.35 46 12342 7412 90608647
Injury associated with device 111.45 23.35 36 12352 4428 90611631
Pathological fracture 108.17 23.35 43 12345 9617 90606442
Cerebrovascular accident 107.78 23.35 107 12281 123426 90492633
Arrhythmia 93.34 23.35 63 12325 42269 90573790
Hip fracture 92.09 23.35 57 12331 33020 90583039
Wrong product administered 88.90 23.35 35 12353 7630 90608429
Aortic dissection 87.86 23.35 26 12362 2391 90613668
Arthralgia 87.02 23.35 268 12120 778254 89837805
Renal impairment 85.86 23.35 88 12300 105333 90510726
Myalgia 85.07 23.35 112 12276 175013 90441046
Injection site mass 82.38 23.35 46 12342 22044 90594015
Osteoporotic fracture 74.40 23.35 27 12361 4709 90611350
Angina pectoris 73.96 23.35 53 12335 39107 90576952
Osteonecrosis of jaw 71.74 23.35 52 12336 39051 90577008
Pelvic fracture 71.63 23.35 37 12351 15182 90600877
Injection site pruritus 71.29 23.35 59 12329 53775 90562284
Humerus fracture 70.97 23.35 32 12356 9753 90606306
Occupational exposure to product 69.72 23.35 22 12366 2509 90613550
Unevaluable event 68.26 23.35 58 12330 54790 90561269
Hospitalisation 66.98 23.35 85 12303 128015 90488044
Atypical femur fracture 66.42 23.35 27 12361 6394 90609665
Blood parathyroid hormone increased 63.11 23.35 22 12366 3415 90612644
Acute myocardial infarction 63.10 23.35 46 12342 34844 90581215
Bone density abnormal 62.80 23.35 23 12365 4117 90611942
Injection site warmth 61.32 23.35 35 12353 17480 90598579
Physical deconditioning 59.79 23.35 19 12369 2216 90613843
Upper limb fracture 59.58 23.35 37 12351 21541 90594518
Wrist fracture 59.52 23.35 33 12355 15591 90600468
Marasmus 58.52 23.35 15 12373 808 90615251
Injection site rash 58.16 23.35 38 12350 24135 90591924
Intercepted product administration error 57.22 23.35 15 12373 883 90615176
Hypocalcaemia 55.18 23.35 46 12342 42322 90573737
Injection site urticaria 55.15 23.35 33 12355 17978 90598081
Injection site reaction 52.77 23.35 64 12324 92016 90524043
Atrial fibrillation 52.20 23.35 77 12311 133534 90482525
Injection site induration 50.85 23.35 26 12362 10442 90605617
Pain in jaw 50.22 23.35 46 12342 47939 90568120
Dementia 49.00 23.35 34 12354 23827 90592232
Blood alkaline phosphatase increased 48.21 23.35 45 12343 48034 90568025
Ulna fracture 47.35 23.35 14 12374 1283 90614776
Blood calcium decreased 46.15 23.35 36 12352 30146 90585913
Diarrhoea 44.45 23.35 38 12350 939152 89676907
Therapy interrupted 41.07 23.35 42 12346 50066 90565993
Product storage error 39.60 23.35 28 12360 20213 90595846
Maternal exposure during pregnancy 37.91 23.35 3 12385 360060 90255999
Pseudarthrosis 35.55 23.35 9 12379 461 90615598
Fractured sacrum 35.03 23.35 13 12375 2414 90613645
Myocardial ischaemia 33.92 23.35 22 12366 13792 90602267
Groin pain 33.86 23.35 21 12367 12192 90603867
Multiple fractures 33.18 23.35 19 12369 9543 90606516
Death 32.57 23.35 136 12252 456415 90159644
Subdural haematoma 32.50 23.35 23 12365 16622 90599437
Accidental exposure to product 32.01 23.35 34 12354 42332 90573727
Drug ineffective 32.00 23.35 91 12297 1384207 89231852
Wrong technique in product usage process 31.99 23.35 44 12344 71527 90544532
Confusional state 31.73 23.35 7 12381 386198 90229861
Systemic lupus erythematosus 30.89 23.35 6 12382 361890 90254169
Hepatic enzyme increased 30.75 23.35 6 12382 360730 90255329
Wound 30.60 23.35 3 12385 302977 90313082
Product use in unapproved indication 29.94 23.35 5 12383 336231 90279828
Tooth extraction 29.92 23.35 19 12369 11494 90604565
Abdominal discomfort 29.81 23.35 14 12374 477314 90138745
Atypical fracture 29.46 23.35 9 12379 922 90615137
Vomiting 29.31 23.35 39 12349 788254 89827805
Tartrate-resistant acid phosphatase increased 28.82 23.35 4 12384 4 90616055
Cerebral haemorrhage 28.40 23.35 29 12359 34493 90581566
Drug intolerance 28.14 23.35 13 12375 447578 90168481
Extraskeletal ossification 27.21 23.35 6 12382 168 90615891
Vertebroplasty 27.16 23.35 7 12381 385 90615674
Condition aggravated 27.02 23.35 25 12363 595520 90020539
Spinal operation 26.93 23.35 17 12371 10179 90605880
Drug hypersensitivity 26.85 23.35 15 12373 463594 90152465
Loose tooth 26.38 23.35 12 12376 3731 90612328
Sudden death 25.87 23.35 17 12371 10892 90605167
Therapy non-responder 25.32 23.35 57 12331 136647 90479412
Drug interaction 24.85 23.35 4 12384 276449 90339610
Intracranial aneurysm 24.53 23.35 12 12376 4386 90611673
Loss of consciousness 24.34 23.35 57 12331 140181 90475878
Injection site discomfort 23.87 23.35 13 12375 5927 90610132
Deep vein thrombosis 23.85 23.35 44 12344 91576 90524483
Infection 23.57 23.35 10 12378 362084 90253975

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
Off label use 92.68 51.02 80 659 638255 41982341
Fall 75.89 51.02 48 691 234472 42386124
Compression fracture 66.87 51.02 15 724 3727 42616869
Spinal fracture 58.08 51.02 16 723 9174 42611422

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
Fall 491.49 23.12 399 8636 603083 109977181
Femur fracture 293.58 23.12 117 8918 44352 110535912
Spinal compression fracture 255.86 23.12 84 8951 18308 110561956
Spinal fracture 254.17 23.12 88 8947 22545 110557719
Femoral neck fracture 243.87 23.12 74 8961 12493 110567771
Compression fracture 243.13 23.12 69 8966 9230 110571034
Injection site pain 187.97 23.12 138 8897 177784 110402480
Fracture 187.41 23.12 72 8963 24716 110555548
Thoracic vertebral fracture 176.75 23.12 50 8985 6605 110573659
Injection site swelling 171.84 23.12 89 8946 61701 110518563
Radius fracture 157.53 23.12 41 8994 3959 110576305
Injection site erythema 146.87 23.12 93 8942 94083 110486181
Cardiac failure 140.80 23.12 119 8916 187507 110392757
Cerebral infarction 133.65 23.12 71 8964 51767 110528497
Bone density decreased 133.52 23.12 50 8985 15992 110564272
Lumbar vertebral fracture 124.11 23.12 41 8994 9090 110571174
Transient ischaemic attack 117.08 23.12 70 8965 63912 110516352
Myocardial infarction 83.19 23.12 90 8945 191993 110388271
Aortic dissection 82.78 23.12 26 9009 4907 110575357
Bone pain 78.92 23.12 55 8980 65078 110515186
Marasmus 64.97 23.12 17 9018 1674 110578590
Hip fracture 63.08 23.12 38 8997 35113 110545151
Cerebrovascular accident 61.67 23.12 75 8960 181209 110399055
Humerus fracture 59.57 23.12 25 9010 10751 110569513
Renal impairment 59.35 23.12 75 8960 188370 110391894
Injection site mass 58.61 23.12 32 9003 24581 110555683
Arthralgia 58.26 23.12 167 8868 779465 109800799
Acute myocardial infarction 56.38 23.12 50 8985 83727 110496537
Pelvic fracture 56.12 23.12 26 9009 14128 110566136
Angina pectoris 56.08 23.12 44 8991 62251 110518013
Osteonecrosis of jaw 52.28 23.12 38 8997 47979 110532285
Bone density abnormal 50.93 23.12 17 9018 3886 110576378
Pathological fracture 50.52 23.12 23 9012 12009 110568255
Ulna fracture 50.03 23.12 13 9022 1245 110579019
Unevaluable event 49.40 23.12 40 8995 59187 110521077
Myalgia 44.10 23.12 71 8964 222310 110357954
Wrist fracture 43.60 23.12 22 9013 14395 110565869
Pseudarthrosis 43.52 23.12 9 9026 314 110579950
Atypical femur fracture 43.20 23.12 17 9018 6202 110574062
Injection site induration 42.32 23.12 20 9015 11363 110568901
Arrhythmia 41.86 23.12 39 8996 69536 110510728
Hypocalcaemia 40.01 23.12 37 8998 65329 110514935
Injection site warmth 39.70 23.12 22 9013 17383 110562881
Injection site pruritus 39.36 23.12 33 9002 51225 110529039
Blood calcium decreased 38.18 23.12 28 9007 35817 110544447
Physical deconditioning 36.78 23.12 13 9022 3524 110576740
Dementia 36.61 23.12 26 9009 31647 110548617
Blood parathyroid hormone increased 34.46 23.12 13 9022 4235 110576029
Diarrhoea 34.18 23.12 26 9009 1139479 109440785
Groin pain 33.82 23.12 19 9016 15409 110564855
Atrial fibrillation 33.41 23.12 64 8971 229578 110350686
Hospitalisation 33.14 23.12 49 8986 142444 110437820
Extraskeletal ossification 32.17 23.12 6 9029 121 110580143
Injection site urticaria 31.89 23.12 19 9016 17196 110563068
Fractured sacrum 31.14 23.12 10 9025 2026 110578238
Upper limb fracture 30.95 23.12 20 9015 20868 110559396
Drug ineffective 29.96 23.12 49 8986 1520491 109059773
Tartrate-resistant acid phosphatase increased 29.61 23.12 4 9031 7 110580257
Injection site discomfort 28.36 23.12 13 9022 6894 110573370
Therapy interrupted 28.19 23.12 27 9008 49795 110530469
Wrong product administered 28.18 23.12 15 9020 10945 110569319
Multiple fractures 28.09 23.12 14 9021 8926 110571338
Drug interaction 27.64 23.12 4 9031 500179 110080085
Pain in jaw 27.57 23.12 27 9008 51150 110529114
Cerebral haemorrhage 27.30 23.12 30 9005 64938 110515326
Loose tooth 26.55 23.12 10 9025 3243 110577021
Injection site rash 26.55 23.12 19 9016 23400 110556864
Vertebroplasty 26.07 23.12 6 9029 346 110579918
Loss of consciousness 25.28 23.12 52 8983 196254 110384010
Atypical fracture 23.89 23.12 7 9028 1045 110579219
Blood alkaline phosphatase increased 23.52 23.12 29 9006 70906 110509358

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC M05BX06 MUSCULO-SKELETAL SYSTEM
DRUGS FOR TREATMENT OF BONE DISEASES
DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION
Other drugs affecting bone structure and mineralization
CHEBI has role CHEBI:50646 bone density conservation agent

Related Drugs by ATC class:

M05BX Other drugs affecting bone structure and mineralization 8 drugs
aluminium chlorohydrateburosumabcolecalciferoldenosumabipriflavonemenatetrenonestrontium ranelatevosoritide

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

DiseaseRelationSNOMED_IDDOID
Postmenopausal osteoporosis indication 102447009
Hypocalcemia contraindication 5291005




🐶 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
Sclerostin Glycoprotein BINDING AGENT Kd 11.70 IUPHAR DRUG LABEL

External reference:

IDSource
4038317 VANDF
CHEBI:752916 CHEBI
CHEMBL2107874 ChEMBL_ID
D10156 KEGG_DRUG
C557282 MESH_SUPPLEMENTAL_RECORD_UI
8092 IUPHAR_LIGAND_ID
DB11866 DRUGBANK_ID
787359005 SNOMEDCT_US
787415000 SNOMEDCT_US
C3661283 UMLSCUI
9533 INN_ID
313417 MMSL
36679 MMSL
d09226 MMSL
017957 NDDF
3VHF2ZD92J UNII
2123126 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Evenity HUMAN PRESCRIPTION DRUG LABEL 1 55513-509 INJECTION, SOLUTION 105 mg SUBCUTANEOUS BLA 31 sections
Evenity HUMAN PRESCRIPTION DRUG LABEL 1 55513-880 INJECTION, SOLUTION 105 mg SUBCUTANEOUS BLA 31 sections
Evenity HUMAN PRESCRIPTION DRUG LABEL 1 55513-998 INJECTION, SOLUTION 105 mg SUBCUTANEOUS BLA 31 sections