pegvisomant Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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

Approvals:

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

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 525.87 30.19 82 2949 691 46682340
Blood growth hormone increased 139.31 30.19 24 3007 388 46682643
Lipohypertrophy 82.15 30.19 17 3014 755 46682276
Pituitary tumour 79.27 30.19 17 3014 898 46682133
Pituitary tumour benign 74.06 30.19 18 3013 1663 46681368
Needle issue 72.03 30.19 23 3008 5781 46677250
Insulin-like growth factor decreased 61.83 30.19 12 3019 383 46682648
Injection site hypertrophy 60.43 30.19 9 3022 53 46682978
Pituitary tumour recurrent 59.08 30.19 9 3022 63 46682968
Glycosylated haemoglobin increased 57.91 30.19 23 3008 10853 46672178
Headache 52.42 30.19 103 2928 478249 46204782
Product use issue 49.00 30.19 44 2987 94600 46588431
Neoplasm progression 46.25 30.19 26 3005 26657 46656374
Product dose omission issue 41.86 30.19 53 2978 168467 46514564
Injection site mass 41.43 30.19 20 3011 15020 46668011
Insulin-like growth factor abnormal 40.28 30.19 5 3026 4 46683027
Lipodystrophy acquired 36.40 30.19 10 3021 1495 46681536
Injection site pain 33.64 30.19 38 2993 107114 46575917
Poor quality product administered 33.55 30.19 11 3020 2998 46680033
Bone density increased 32.87 30.19 7 3024 357 46682674
Blood glucose increased 30.55 30.19 30 3001 71983 46611048

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 567.99 34.32 91 1831 950 29949606
Blood growth hormone increased 133.91 34.32 21 1901 185 29950371
Pituitary tumour benign 63.96 34.32 14 1908 825 29949731
Product use issue 59.80 34.32 37 1885 45979 29904577
Blood testosterone decreased 53.03 34.32 17 1905 4379 29946177
Pituitary tumour 47.50 34.32 10 1912 489 29950067
Product dose omission issue 44.83 34.32 41 1881 91590 29858966
Cholelithiasis 44.54 34.32 23 1899 20202 29930354
Injection site bruising 44.51 34.32 17 1905 7321 29943235
Insulin-like growth factor decreased 41.17 34.32 8 1914 260 29950296
Headache 40.77 34.32 54 1868 182252 29768304
Needle issue 38.87 34.32 13 1909 3819 29946737
Glycosylated haemoglobin increased 36.97 34.32 16 1906 9475 29941081
Pituitary tumour recurrent 36.78 34.32 6 1916 69 29950487
Arthralgia 36.29 34.32 44 1878 135747 29814809
Blood testosterone free decreased 36.25 34.32 6 1916 76 29950480

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

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Acromegaly indication 74107003 DOID:2449

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 GPCR ANTAGONIST DRUG LABEL DRUG LABEL

External reference:

IDSource
D05394 KEGG_DRUG
4021390 VUID
N0000148808 NUI
4021390 VANDF
C0768710 UMLSCUI
CHEMBL1201515 ChEMBL_ID
DB00082 DRUGBANK_ID
C406545 MESH_SUPPLEMENTAL_RECORD_UI
7485 IUPHAR_LIGAND_ID
7941 INN_ID
N824AOU5XV UNII
278739 RXNORM
17174 MMSL
46371 MMSL
d04854 MMSL
009929 NDDF
409201000 SNOMEDCT_US
409204008 SNOMEDCT_US

Pharmaceutical products:

None