pegvisomant 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	5015	218620-50-9

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
10	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Nov. 13, 2002	EMA
March 25, 2003	FDA	PHARMACIA AND UPJOHN

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Insulin-like growth factor increased	680.55	32.36	108	4658	763	56286538
Blood growth hormone increased	156.67	32.36	28	4738	426	56286875
Needle issue	144.94	32.36	46	4720	8692	56278609
Lipohypertrophy	92.91	32.36	19	4747	605	56286696
Rectal polyp	86.94	32.36	20	4746	1113	56286188
Injection site mass	85.14	32.36	37	4729	16756	56270545
Insulin-like growth factor decreased	82.91	32.36	16	4750	376	56286925
Pituitary tumour	80.90	32.36	18	4748	861	56286440
Insulin-like growth factor abnormal	77.90	32.36	10	4756	8	56287293
Injection site pain	75.14	32.36	69	4697	117049	56170252
Change of bowel habit	74.78	32.36	20	4746	2069	56285232
Sensitisation	72.30	32.36	20	4746	2348	56284953
Injection site hypertrophy	72.13	32.36	11	4755	57	56287244
Injection site discomfort	69.36	32.36	22	4744	4138	56283163
Intestinal haemorrhage	68.55	32.36	21	4745	3525	56283776
Pituitary tumour benign	66.85	32.36	18	4748	1910	56285391
Injection site bruising	63.67	32.36	40	4726	38481	56248820
Polyp	61.67	32.36	22	4744	5920	56281381
Product dose omission issue	61.64	32.36	81	4685	204672	56082629
Frustration tolerance decreased	56.54	32.36	21	4745	6332	56280969
Proctalgia	55.67	32.36	20	4746	5489	56281812
Poor quality product administered	55.32	32.36	17	4749	2882	56284419
Glycosylated haemoglobin increased	54.63	32.36	24	4742	11141	56276160
Diabetes mellitus	54.52	32.36	41	4725	52694	56234607
Urine odour abnormal	54.42	32.36	20	4746	5854	56281447
Pituitary tumour recurrent	54.39	32.36	9	4757	84	56287217
Furuncle	53.82	32.36	20	4746	6039	56281262
Urine abnormality	51.86	32.36	20	4746	6679	56280622
Blood glucose decreased	50.71	32.36	27	4739	19060	56268241
Duodenal ulcer	50.59	32.36	20	4746	7135	56280166
Gallbladder disorder	50.27	32.36	26	4740	17308	56269993
Lipodystrophy acquired	48.61	32.36	13	4753	1344	56285957
Headache	48.38	32.36	129	4637	558915	55728386
Bladder disorder	48.37	32.36	20	4746	8004	56279297
Postoperative wound infection	45.50	32.36	20	4746	9293	56278008
Peripheral coldness	45.38	32.36	21	4745	10990	56276311
Thyroid disorder	43.59	32.36	22	4744	13916	56273385
Musculoskeletal discomfort	43.11	32.36	23	4743	16295	56271006
Underdose	42.61	32.36	26	4740	23731	56263570
Neoplasm progression	42.52	32.36	29	4737	31987	56255314
Mass	42.31	32.36	21	4745	12818	56274483
Product use issue	38.93	32.36	62	4704	185979	56101322
Exostosis	36.51	32.36	20	4746	14923	56272378
Lung neoplasm malignant	36.32	32.36	21	4745	17375	56269926
Hyperhidrosis	35.91	32.36	42	4724	94046	56193255

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Insulin-like growth factor increased	708.53	32.21	116	2484	1069	31693675
Blood growth hormone increased	186.82	32.21	31	2569	307	31694437
Product dose omission issue	73.26	32.21	64	2536	105522	31589222
Insulin-like growth factor abnormal	71.72	32.21	9	2591	5	31694739
Needle issue	68.92	32.21	23	2577	5250	31689494
Pituitary tumour benign	60.65	32.21	14	2586	817	31693927
Injection site bruising	59.63	32.21	23	2577	7952	31686792
Pituitary tumour	54.97	32.21	12	2588	543	31694201
Headache	54.75	32.21	71	2529	183581	31511163
Blood testosterone decreased	53.31	32.21	18	2582	4255	31690489
Cholelithiasis	51.06	32.21	27	2573	19452	31675292
Arthralgia	48.96	32.21	61	2539	151363	31543381
Insulin-like growth factor decreased	45.07	32.21	9	2591	262	31694482
Product use issue	42.48	32.21	36	2564	56723	31638021
Injection site pain	41.35	32.21	29	2571	34605	31660139
Injection site hypertrophy	38.11	32.21	5	2595	6	31694738
Growth hormone-producing pituitary tumour	35.99	32.21	6	2594	61	31694683
Pituitary tumour recurrent	35.90	32.21	6	2594	62	31694682
Blood testosterone free decreased	35.15	32.21	6	2594	71	31694673
Glycosylated haemoglobin increased	34.77	32.21	17	2583	10383	31684361
Injection site erosion	33.83	32.21	6	2594	90	31694654
Lipohypertrophy	33.53	32.21	7	2593	255	31694489

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Insulin-like growth factor increased	1321.56	30.63	216	6906	1555	70919767
Blood growth hormone increased	306.78	30.63	54	7068	624	70920698
Needle issue	205.86	30.63	66	7056	10849	70910473
Product dose omission issue	148.61	30.63	143	6979	217325	70703997
Insulin-like growth factor abnormal	142.78	30.63	19	7103	19	70921303
Pituitary tumour	125.89	30.63	28	7094	1123	70920199
Insulin-like growth factor decreased	114.65	30.63	23	7099	556	70920766
Injection site pain	109.12	30.63	92	7030	117527	70803795
Pituitary tumour benign	104.54	30.63	28	7094	2451	70918871
Injection site bruising	101.10	30.63	57	7065	37975	70883347
Injection site hypertrophy	99.59	30.63	15	7107	57	70921265
Injection site mass	97.60	30.63	44	7078	18299	70903023
Lipohypertrophy	94.76	30.63	21	7101	828	70920494
Glycosylated haemoglobin increased	87.11	30.63	40	7082	17351	70903971
Headache	85.78	30.63	183	6939	580222	70341100
Product use issue	84.53	30.63	97	7025	179840	70741482
Pituitary tumour recurrent	81.17	30.63	14	7108	142	70921180
Rectal polyp	78.22	30.63	20	7102	1460	70919862
Polyp	75.27	30.63	28	7094	7142	70914180
Injection site discomfort	70.96	30.63	24	7098	4645	70916677
Poor quality product administered	70.47	30.63	22	7100	3309	70918013
Sensitisation	68.05	30.63	20	7102	2453	70918869
Change of bowel habit	66.77	30.63	20	7102	2619	70918703
Neoplasm progression	60.57	30.63	44	7078	45184	70876138
Blood testosterone decreased	60.56	30.63	18	7104	2295	70919027
Frustration tolerance decreased	58.73	30.63	23	7099	6742	70914580
Diabetes mellitus	56.11	30.63	51	7071	71773	70849549
Intestinal haemorrhage	54.14	30.63	21	7101	5999	70915323
Gallbladder disorder	53.79	30.63	29	7093	17683	70903639
Urine odour abnormal	51.87	30.63	20	7102	5623	70915699
Furuncle	51.08	30.63	21	7101	6977	70914345
Blood glucose increased	49.09	30.63	56	7066	102926	70818396
Blood glucose decreased	47.93	30.63	30	7092	24129	70897193
Blood pressure increased	46.03	30.63	74	7048	188443	70732879
Cholelithiasis	45.82	30.63	38	7084	47302	70874020
Arthralgia	45.73	30.63	132	6990	503258	70418064
Urine abnormality	45.52	30.63	20	7102	7818	70913504
Blood thyroid stimulating hormone decreased	45.43	30.63	18	7104	5436	70915886
Low density lipoprotein increased	44.97	30.63	20	7102	8045	70913277
Thyroid disorder	44.61	30.63	23	7099	12809	70908513
Bladder disorder	44.44	30.63	20	7102	8269	70913053
Proctalgia	44.23	30.63	20	7102	8363	70912959
Bone density increased	40.35	30.63	10	7112	643	70920679
Off label use	39.55	30.63	163	6959	742897	70178425
Heart rate decreased	38.86	30.63	39	7083	61976	70859346
Postoperative wound infection	38.49	30.63	20	7102	11318	70910004
Musculoskeletal discomfort	37.54	30.63	23	7099	17809	70903513
Blood prolactin decreased	37.33	30.63	8	7114	269	70921053
Mass	37.18	30.63	22	7100	16004	70905318
Blood testosterone free decreased	36.89	30.63	6	7116	41	70921281
Exostosis	36.74	30.63	21	7101	14324	70906998
Peripheral coldness	36.53	30.63	21	7101	14479	70906843
Duodenal ulcer	35.51	30.63	21	7101	15259	70906063
Hyperhidrosis	35.35	30.63	54	7068	131532	70789790
Fatigue	34.94	30.63	169	6953	824150	70097172
Growth hormone-producing pituitary tumour	34.26	30.63	6	7116	67	70921255
Stress	34.14	30.63	38	7084	67928	70853394
Underdose	33.57	30.63	26	7096	29357	70891965
Injection site haemorrhage	32.28	30.63	24	7098	25503	70895819
Illness	31.76	30.63	26	7096	31765	70889557
Injection site erosion	30.71	30.63	6	7116	126	70921196
Lung neoplasm malignant	30.70	30.63	23	7099	24719	70896603

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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 | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Growth hormone receptor	GPCR	P10912	GHR_HUMAN	ANTAGONIST				DRUG LABEL	DRUG LABEL

External reference:

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

Pharmaceutical products:

None