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	672.94	31.35	108	5351	811	63482752
Needle issue	168.72	31.35	54	5405	10322	63473241
Blood growth hormone increased	155.26	31.35	28	5431	442	63483121
Rectal polyp	106.18	31.35	24	5435	1215	63482348
Lipohypertrophy	97.24	31.35	20	5439	645	63482918
Injection site mass	93.63	31.35	41	5418	18615	63464948
Change of bowel habit	92.55	31.35	24	5435	2169	63481394
Injection site pain	87.19	31.35	79	5380	129721	63353842
Insulin-like growth factor abnormal	83.87	31.35	11	5448	12	63483551
Intestinal haemorrhage	83.52	31.35	25	5434	3822	63479741
Injection site discomfort	83.12	31.35	26	5433	4604	63478959
Insulin-like growth factor decreased	82.50	31.35	16	5443	380	63483183
Sensitisation	82.23	31.35	24	5435	3362	63480201
Pituitary tumour	79.26	31.35	18	5441	930	63482633
Polyp	74.37	31.35	26	5433	6495	63477068
Frustration tolerance decreased	72.62	31.35	26	5433	6962	63476601
Injection site bruising	72.37	31.35	45	5414	41865	63441698
Injection site hypertrophy	71.95	31.35	11	5448	57	63483506
Pituitary tumour benign	70.65	31.35	19	5440	1976	63481587
Proctalgia	68.30	31.35	24	5435	6086	63477477
Diabetes mellitus	67.51	31.35	48	5411	55762	63427801
Urine odour abnormal	67.25	31.35	24	5435	6365	63477198
Furuncle	66.61	31.35	24	5435	6542	63477021
Urine abnormality	65.05	31.35	24	5435	6995	63476568
Duodenal ulcer	62.71	31.35	24	5435	7732	63475831
Bladder disorder	59.39	31.35	24	5435	8922	63474641
Product dose omission issue	59.36	31.35	86	5373	234227	63249336
Gallbladder disorder	59.26	31.35	30	5429	18812	63464751
Blood glucose decreased	59.09	31.35	31	5428	20921	63462642
Peripheral coldness	55.45	31.35	25	5434	12140	63471423
Postoperative wound infection	54.76	31.35	24	5435	10901	63472662
Pituitary tumour recurrent	54.25	31.35	9	5450	84	63483479
Poor quality product administered	53.64	31.35	17	5442	3139	63480424
Thyroid disorder	53.18	31.35	26	5433	15136	63468427
Mass	52.09	31.35	25	5434	13975	63469588
Glycosylated haemoglobin increased	51.85	31.35	24	5435	12374	63471189
Musculoskeletal discomfort	51.85	31.35	27	5432	17940	63465623
Neoplasm progression	50.30	31.35	34	5425	36394	63447169
Underdose	48.70	31.35	30	5429	27426	63456137
Headache	48.31	31.35	141	5318	633100	62850463
Lipodystrophy acquired	47.53	31.35	13	5446	1439	63482124
Lung neoplasm malignant	44.12	31.35	25	5434	19608	63463955
Exostosis	43.56	31.35	24	5435	17838	63465725
Blood pressure increased	40.27	31.35	59	5400	162003	63321560
Jaundice	39.66	31.35	27	5432	29224	63454339
Bone disorder	39.60	31.35	24	5435	21302	63462261
Bone pain	38.07	31.35	34	5425	54607	63428956
Illness	37.13	31.35	32	5427	49027	63434536
Hyperhidrosis	37.07	31.35	46	5413	107790	63375773
Limb discomfort	36.93	31.35	26	5433	29690	63453873
Product use issue	35.49	31.35	66	5393	220454	63263109
Full blood count decreased	35.22	31.35	24	5435	26000	63457563
Blood pressure systolic increased	34.02	31.35	30	5429	47367	63436196
Blood glucose increased	32.49	31.35	38	5421	83718	63399845

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	729.07	32.68	120	2796	1123	34952892
Blood growth hormone increased	223.81	32.68	37	2879	351	34953664
Insulin-like growth factor abnormal	86.32	32.68	11	2905	8	34954007
Product dose omission issue	84.91	32.68	74	2842	119637	34834378
Needle issue	72.72	32.68	25	2891	6140	34947875
Blood testosterone decreased	60.59	32.68	20	2896	4337	34949678
Pituitary tumour	60.00	32.68	13	2903	558	34953457
Pituitary tumour benign	59.60	32.68	14	2902	867	34953148
Headache	57.89	32.68	77	2839	200558	34753457
Injection site bruising	57.40	32.68	23	2893	8640	34945375
Arthralgia	54.86	32.68	69	2847	169972	34784043
Cholelithiasis	51.29	32.68	28	2888	21120	34932895
Glycosylated haemoglobin increased	45.08	32.68	21	2895	11339	34942676
Insulin-like growth factor decreased	44.85	32.68	9	2907	264	34953751
Product use issue	44.51	32.68	39	2877	63177	34890838
Injection site pain	42.27	32.68	31	2885	38974	34915041
Acromegaly	37.40	32.68	6	2910	46	34953969
Growth hormone-producing pituitary tumour	36.25	32.68	6	2910	57	34953958
Injection site hypertrophy	35.56	32.68	5	2911	13	34954002
Blood testosterone free decreased	35.05	32.68	6	2910	71	34953944
Pituitary tumour recurrent	33.19	32.68	6	2910	99	34953916
Lipohypertrophy	33.00	32.68	7	2909	271	34953744
Injection site erosion	32.91	32.68	6	2910	104	34953911

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	1323.99	29.88	219	7965	1667	79734537
Blood growth hormone increased	334.27	29.88	59	8125	677	79735527
Needle issue	236.56	29.88	77	8107	12991	79723213
Insulin-like growth factor abnormal	163.86	29.88	22	8162	24	79736180
Product dose omission issue	157.26	29.88	158	8026	247379	79488825
Pituitary tumour	134.50	29.88	30	8154	1192	79735012
Injection site pain	125.60	29.88	105	8079	129733	79606471
Insulin-like growth factor decreased	113.90	29.88	23	8161	562	79735642
Injection site bruising	109.20	29.88	62	8122	40940	79695264
Pituitary tumour benign	107.55	29.88	29	8155	2547	79733657
Injection site mass	105.06	29.88	48	8136	20136	79716068
Lipohypertrophy	98.92	29.88	22	8162	862	79735342
Injection site hypertrophy	97.49	29.88	15	8169	66	79736138
Rectal polyp	94.71	29.88	24	8160	1653	79734551
Glycosylated haemoglobin increased	94.61	29.88	44	8140	19216	79716988
Polyp	93.05	29.88	34	8150	8073	79728131
Headache	86.63	29.88	200	7984	653572	79082632
Injection site discomfort	83.65	29.88	28	8156	5138	79731066
Change of bowel habit	82.89	29.88	24	8160	2733	79733471
Product use issue	81.73	29.88	104	8080	209718	79526486
Sensitisation	78.55	29.88	24	8160	3287	79732917
Pituitary tumour recurrent	77.88	29.88	14	8170	179	79736025
Frustration tolerance decreased	73.44	29.88	28	8156	7474	79728730
Intestinal haemorrhage	70.23	29.88	26	8158	6400	79729804
Neoplasm progression	69.86	29.88	51	8133	51631	79684573
Blood testosterone decreased	68.40	29.88	20	8164	2357	79733847
Poor quality product administered	68.04	29.88	22	8162	3623	79732581
Diabetes mellitus	66.76	29.88	59	8125	78331	79657873
Urine odour abnormal	63.52	29.88	24	8160	6249	79729955
Furuncle	62.65	29.88	25	8159	7529	79728675
Gallbladder disorder	61.81	29.88	33	8151	19307	79716897
Cholelithiasis	58.01	29.88	46	8138	52618	79683586
Urine abnormality	57.23	29.88	24	8160	8195	79728009
Blood pressure increased	55.80	29.88	87	8097	211273	79524931
Blood glucose decreased	54.98	29.88	34	8150	26200	79710004
Bladder disorder	54.72	29.88	24	8160	9141	79727063
Thyroid disorder	53.54	29.88	27	8157	14052	79722152
Proctalgia	52.71	29.88	24	8160	9977	79726227
Arthralgia	50.92	29.88	151	8033	571652	79164552
Illness	49.88	29.88	40	8144	46471	79689733
Blood glucose increased	47.90	29.88	59	8125	114916	79621288
Postoperative wound infection	46.79	29.88	24	8160	12937	79723267
Heart rate decreased	46.51	29.88	46	8138	70270	79665934
Mass	45.36	29.88	26	8158	17446	79718758
Musculoskeletal discomfort	44.87	29.88	27	8157	19808	79716396
Peripheral coldness	44.79	29.88	25	8159	15945	79720259
Acromegaly	44.52	29.88	8	8176	102	79736102
Blood thyroid stimulating hormone decreased	44.23	29.88	18	8166	5698	79730506
Duodenal ulcer	44.22	29.88	25	8159	16344	79719860
Exostosis	43.53	29.88	25	8159	16833	79719371
Low density lipoprotein increased	43.27	29.88	20	8164	8602	79727602
Off label use	42.91	29.88	195	7989	907020	78829184
Blood prolactin decreased	42.57	29.88	9	8175	277	79735927
Bone disorder	40.62	29.88	25	8159	19088	79717116
Neoplasm	39.17	29.88	19	8165	9097	79727107
Underdose	38.75	29.88	30	8154	33121	79703083
Fatigue	38.25	29.88	192	7992	929535	78806669
Bone density increased	37.76	29.88	10	8174	819	79735385
Blood testosterone free decreased	36.76	29.88	6	8178	41	79736163
Hyperhidrosis	36.70	29.88	60	8124	151432	79584772
Lung neoplasm malignant	36.58	29.88	27	8157	27765	79708439
Stress	35.00	29.88	42	8142	79570	79656634
Growth hormone-producing pituitary tumour	34.46	29.88	6	8178	63	79736141
Bone pain	34.17	29.88	35	8149	55707	79680497
Limb discomfort	32.58	29.88	27	8157	32823	79703381
Injection site haemorrhage	32.09	29.88	25	8159	27845	79708359
Full blood count decreased	30.75	29.88	24	8160	26795	79709409
Injection site erosion	30.14	29.88	6	8178	136	79736068
Non-high-density lipoprotein cholesterol increased	30.13	29.88	7	8177	334	79735870

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
4021390	VANDF
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