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

Stem definitionDrug idCAS RN
5015 218620-50-9

Description:

MoleculeDescription

Synonyms:

  • B-2036 PEG
  • pegvisomant
  • somavert
  • pegvisomant (genetical recombination)
  • B2036-PEG
  • trovert
is a genetically engineered analogue of human growth hormone that functions as a growth hormone-receptor antagonist; used to treat Acromegaly
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
10 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
March 25, 2003 FDA PHARMACIA AND UPJOHN
Nov. 13, 2002 EMA

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
Insulin-like growth factor increased 709.05 31.22 111 6339 863 90621134
Needle issue 229.34 31.22 70 6380 13864 90608133
Blood growth hormone increased 177.17 31.22 31 6419 499 90621498
Injection site mass 114.43 31.22 47 6403 22043 90599954
Injection site pain 107.54 31.22 93 6357 173606 90448391
Insulin-like growth factor abnormal 106.90 31.22 14 6436 21 90621976
Change of bowel habit 106.17 31.22 26 6424 2257 90619740
Insulin-like growth factor decreased 104.06 31.22 19 6431 393 90621604
Rectal polyp 101.90 31.22 22 6428 1091 90620906
Pituitary tumour 100.08 31.22 21 6429 908 90621089
Lipohypertrophy 98.90 31.22 20 6430 719 90621278
Frustration tolerance decreased 93.95 31.22 31 6419 7865 90614132
Injection site discomfort 89.89 31.22 28 6422 5912 90616085
Intestinal haemorrhage 88.99 31.22 26 6424 4421 90617576
Diabetes mellitus 88.58 31.22 56 6394 64819 90557178
Sensitisation 86.16 31.22 25 6425 4150 90617847
Injection site hypertrophy 84.40 31.22 13 6437 89 90621908
Injection site bruising 83.77 31.22 50 6400 52257 90569740
Polyp 82.95 31.22 28 6422 7616 90614381
Pituitary tumour benign 77.81 31.22 20 6430 2112 90619885
Urine odour abnormal 72.60 31.22 25 6425 7219 90614778
Furuncle 71.55 31.22 25 6425 7536 90614461
Urine abnormality 70.99 31.22 25 6425 7712 90614285
Poor quality product administered 69.60 31.22 21 6429 3987 90618010
Proctalgia 69.57 31.22 25 6425 8173 90613824
Gallbladder disorder 69.41 31.22 32 6418 19771 90602226
Blood glucose decreased 67.26 31.22 33 6417 23396 90598601
Bone pain 66.39 31.22 46 6404 61937 90560060
Duodenal ulcer 65.85 31.22 25 6425 9527 90612470
Blood pressure increased 65.02 31.22 75 6375 197142 90424855
Product dose omission issue 63.15 31.22 90 6360 291597 90330400
Bladder disorder 62.93 31.22 25 6425 10747 90611250
Peripheral coldness 60.04 31.22 26 6424 13866 90608131
Thyroid disorder 60.02 31.22 28 6422 17757 90604240
Neoplasm progression 59.69 31.22 38 6412 44448 90577549
Postoperative wound infection 57.61 31.22 25 6425 13401 90608596
Mass 57.19 31.22 26 6424 15551 90606446
Musculoskeletal discomfort 55.61 31.22 28 6422 20963 90601034
Pituitary tumour recurrent 55.48 31.22 9 6441 89 90621908
Headache 52.51 31.22 157 6293 862589 89759408
Blood glucose increased 50.91 31.22 47 6403 95199 90526798
Lipodystrophy acquired 49.43 31.22 13 6437 1501 90620496
Illness 48.84 31.22 43 6407 81926 90540071
Glycosylated haemoglobin increased 47.91 31.22 23 6427 15539 90606458
Bone disorder 47.45 31.22 26 6424 23094 90598903
Limb discomfort 47.33 31.22 31 6419 38029 90583968
Lung neoplasm malignant 46.27 31.22 26 6424 24247 90597750
Heart rate decreased 44.31 31.22 34 6416 53471 90568526
Jaundice 44.17 31.22 28 6422 32489 90589508
Cholelithiasis 40.52 31.22 32 6418 52474 90569523
Full blood count decreased 38.92 31.22 25 6425 29664 90592333
Calcinosis 37.84 31.22 12 6438 2683 90619314
Underdose 37.61 31.22 31 6419 53986 90568011
Injection site haemorrhage 37.51 31.22 24 6426 28294 90593703
Hyperhidrosis 36.97 31.22 47 6403 136258 90485739
Stress 35.63 31.22 36 6414 81359 90540638
Blood pressure systolic increased 35.53 31.22 31 6419 58314 90563683
Urinary incontinence 33.60 31.22 25 6425 37541 90584456
Haemorrhage 32.80 31.22 32 6418 69337 90552660
Dysuria 32.54 31.22 25 6425 39376 90582621

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
Insulin-like growth factor increased 780.00 33.03 133 3566 1498 42616138
Blood growth hormone increased 303.87 33.03 52 3647 592 42617044
Needle issue 92.45 33.03 33 3666 8694 42608942
Insulin-like growth factor abnormal 85.88 33.03 11 3688 8 42617628
Blood testosterone decreased 77.35 33.03 25 3674 4877 42612759
Growth hormone-producing pituitary tumour 76.91 33.03 13 3686 136 42617500
Pituitary tumour 76.05 33.03 16 3683 572 42617064
Product dose omission issue 75.16 33.03 79 3620 154286 42463350
Blood cholesterol abnormal 70.64 33.03 19 3680 1960 42615676
Injection site pain 61.18 33.03 46 3653 57752 42559884
Gastric hypomotility 59.16 33.03 11 3688 205 42617431
Pituitary tumour benign 57.25 33.03 14 3685 988 42616648
Insulin-like growth factor decreased 56.43 33.03 11 3688 266 42617370
Shunt malfunction 56.27 33.03 11 3688 270 42617366
Viral diarrhoea 54.64 33.03 11 3688 315 42617321
Injection site oedema 53.10 33.03 11 3688 364 42617272
Arthralgia 52.54 33.03 76 3623 205162 42412474
Headache 51.87 33.03 82 3617 239287 42378349
Glycosylated haemoglobin increased 47.66 33.03 23 3676 12901 42604735
Injection site bruising 47.06 33.03 22 3677 11503 42606133
Vital functions abnormal 46.86 33.03 10 3689 383 42617253
Cholelithiasis 45.03 33.03 27 3672 23319 42594317
Injection site erosion 44.00 33.03 8 3691 131 42617505
Breath odour 42.33 33.03 11 3688 992 42616644
Product use issue 42.17 33.03 42 3657 76709 42540927
Shunt occlusion 42.08 33.03 11 3688 1016 42616620
Neoplasm progression 42.06 33.03 28 3671 28972 42588664
Blood testosterone free decreased 41.17 33.03 7 3692 76 42617560
Infrequent bowel movements 40.73 33.03 11 3688 1151 42616485
Injection site haemorrhage 40.62 33.03 20 3679 11716 42605920
Heart rate decreased 38.45 33.03 29 3670 36503 42581133
Lipohypertrophy 37.78 33.03 8 3691 295 42617341
Acromegaly 36.72 33.03 6 3693 50 42617586
Renal haematoma 36.66 33.03 9 3690 645 42616991
Polyp 36.19 33.03 14 3685 4600 42613036
Injection site injury 36.01 33.03 8 3691 370 42617266
Injection site hypertrophy 34.59 33.03 5 3694 16 42617620
Pituitary tumour recurrent 33.49 33.03 6 3693 90 42617546
Strabismus 33.09 33.03 11 3688 2337 42615299

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
Insulin-like growth factor increased 1424.04 28.38 235 9614 2061 110577389
Blood growth hormone increased 439.02 28.38 77 9772 991 110578459
Needle issue 316.30 28.38 100 9749 17740 110561710
Insulin-like growth factor abnormal 185.49 28.38 25 9824 37 110579413
Pituitary tumour 166.36 28.38 35 9814 1218 110578232
Injection site pain 164.36 28.38 132 9717 177790 110401660
Product dose omission issue 149.93 28.38 163 9686 321619 110257831
Insulin-like growth factor decreased 146.82 28.38 28 9821 585 110578865
Injection site mass 121.35 28.38 54 9795 24559 110554891
Polyp 120.91 28.38 42 9807 9938 110569512
Injection site bruising 115.05 28.38 66 9783 51197 110528253
Pituitary tumour benign 108.74 28.38 29 9820 2818 110576632
Lipohypertrophy 104.72 28.38 23 9826 983 110578467
Injection site hypertrophy 102.84 28.38 16 9833 91 110579359
Glycosylated haemoglobin increased 95.04 28.38 45 9804 23574 110555876
Change of bowel habit 94.48 28.38 26 9823 2843 110576607
Frustration tolerance decreased 91.52 28.38 33 9816 8698 110570752
Neoplasm progression 91.32 28.38 62 9787 64533 110514917
Blood pressure increased 90.26 28.38 113 9736 258260 110321190
Blood testosterone decreased 90.05 28.38 25 9824 2823 110576627
Rectal polyp 89.87 28.38 22 9827 1518 110577932
Injection site discomfort 87.27 28.38 30 9819 6877 110572573
Headache 84.02 28.38 218 9631 882159 109697291
Diabetes mellitus 81.73 28.38 69 9780 99312 110480138
Sensitisation 80.75 28.38 25 9824 4126 110575324
Pituitary tumour recurrent 80.23 28.38 14 9835 174 110579276
Heart rate decreased 77.56 28.38 62 9787 82694 110496756
Growth hormone-producing pituitary tumour 76.04 28.38 13 9836 142 110579308
Intestinal haemorrhage 74.15 28.38 27 9822 7314 110572136
Poor quality product administered 73.92 28.38 24 9825 4617 110574833
Gallbladder disorder 69.41 28.38 35 9814 20994 110558456
Injection site haemorrhage 67.41 28.38 40 9809 32988 110546462
Cholelithiasis 66.98 28.38 51 9798 63371 110516079
Blood glucose increased 66.60 28.38 70 9779 132426 110447024
Urine odour abnormal 66.54 28.38 25 9824 7390 110572060
Furuncle 66.24 28.38 26 9823 8642 110570808
Urine abnormality 61.58 28.38 25 9824 9071 110570379
Thyroid disorder 61.20 28.38 30 9819 16939 110562511
Blood glucose decreased 60.93 28.38 36 9813 29452 110549998
Product use issue 58.78 28.38 102 9747 311593 110267857
Blood cholesterol abnormal 58.15 28.38 19 9830 3727 110575723
Bladder disorder 56.70 28.38 25 9824 11112 110568338
Gastric hypomotility 55.08 28.38 11 9838 294 110579156
Illness 53.49 28.38 50 9799 82121 110497329
Bone pain 53.07 28.38 45 9804 65088 110514362
Shunt malfunction 52.96 28.38 11 9838 359 110579091
Proctalgia 52.59 28.38 25 9824 13197 110566253
Neoplasm 50.42 28.38 23 9826 11064 110568386
Acromegaly 49.51 28.38 9 9840 143 110579307
Blood thyroid stimulating hormone decreased 49.36 28.38 20 9829 7219 110572231
Blood prolactin decreased 49.02 28.38 10 9839 298 110579152
Mass 48.69 28.38 27 9822 19603 110559847
Postoperative wound infection 48.44 28.38 25 9824 15728 110563722
Viral diarrhoea 47.77 28.38 11 9838 583 110578867
Arthralgia 47.72 28.38 165 9684 779467 109799983
Peripheral coldness 47.35 28.38 26 9823 18514 110560936
Musculoskeletal discomfort 46.71 28.38 28 9821 23510 110555940
Duodenal ulcer 46.11 28.38 26 9823 19488 110559962
Low density lipoprotein increased 44.99 28.38 21 9828 10645 110568805
Blood testosterone free decreased 44.96 28.38 7 9842 40 110579410
Stress 44.81 28.38 51 9798 105297 110474153
Bone disorder 44.11 28.38 26 9823 21166 110558284
Fatigue 43.44 28.38 218 9631 1215740 109363710
Injection site erosion 41.42 28.38 8 9841 179 110579271
Limb discomfort 41.25 28.38 32 9817 40822 110538628
Off label use 40.31 28.38 249 9600 1499936 109079514
Injection site oedema 39.60 28.38 12 9837 1842 110577608
Hyperhidrosis 37.51 28.38 63 9786 187235 110392215
Renal haematoma 37.47 28.38 10 9839 973 110578477
Lung neoplasm malignant 37.46 28.38 28 9821 33814 110545636
Bone density increased 37.35 28.38 10 9839 985 110578465
Acute kidney injury 37.26 28.38 6 9843 635424 109944026
Vital functions abnormal 36.32 28.38 10 9839 1095 110578355
Shunt occlusion 36.07 28.38 11 9838 1726 110577724
Breath odour 34.58 28.38 11 9838 1981 110577469
Infrequent bowel movements 33.63 28.38 11 9838 2164 110577286
Full blood count decreased 32.10 28.38 25 9824 32074 110547376
Injection site injury 31.75 28.38 9 9840 1095 110578355
Rash 31.48 28.38 17 9832 820947 109758503
Calcinosis 30.71 28.38 11 9838 2841 110576609
Non-high-density lipoprotein cholesterol increased 29.87 28.38 7 9842 401 110579049
Blood luteinising hormone decreased 29.84 28.38 6 9843 166 110579284
Intentional product misuse 29.71 28.38 47 9802 132857 110446593
Lipodystrophy acquired 29.14 28.38 12 9837 4512 110574938
Gait disturbance 28.63 28.38 71 9778 278137 110301313
Strabismus 28.52 28.38 11 9838 3488 110575962

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC H01AX01 SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES
Other anterior pituitary lobe hormones and analogues
FDA MoA N0000010267 Growth Hormone Receptor Antagonists
FDA EPC N0000190119 Growth Hormone Receptor Antagonist
CHEBI has role CHEBI:35610 antineoplastic agent

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

DiseaseRelationSNOMED_IDDOID
Acromegaly indication 74107003 DOID:2449




🐶 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
Growth hormone receptor Membrane receptor ANTAGONIST DRUG LABEL DRUG LABEL

External reference:

IDSource
D05394 KEGG_DRUG
4021390 VUID
N0000148808 NUI
4021390 VANDF
CHEBI:749488 CHEBI
CHEMBL1201515 ChEMBL_ID
C406545 MESH_SUPPLEMENTAL_RECORD_UI
7485 IUPHAR_LIGAND_ID
DB00082 DRUGBANK_ID
278739 RXNORM
17174 MMSL
46371 MMSL
d04854 MMSL
009929 NDDF
409201000 SNOMEDCT_US
409204008 SNOMEDCT_US
C0913469 UMLSCUI
7941 INN_ID
N824AOU5XV UNII

Pharmaceutical products:

None