panitumumab Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
human origin	4955	339177-26-3

Description:

Molecule	Description
Synonyms: panitumumab vectibix ABX-EGF	Recombinant human monoclonal antibody that binds to and inhibits the function of the EPIDERMAL GROWTH FACTOR RECEPTOR. It is used in the treatment of EGFR-expressing metastatic colorectal cancer that expresses wild-type ras gene (see GENES, RAS). Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

panitumumab
vectibix
ABX-EGF

Recombinant human monoclonal antibody that binds to and inhibits the function of the EPIDERMAL GROWTH FACTOR RECEPTOR. It is used in the treatment of EGFR-expressing metastatic colorectal cancer that expresses wild-type ras gene (see GENES, RAS).

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Dec. 3, 2007	EMA	Amgen Europe B.V.
Sept. 27, 2006	FDA	AMGEN

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
Dermatitis acneiform	827.66	26.57	183	8328	3887	46673664
Paronychia	418.99	26.57	108	8403	4458	46673093
Skin toxicity	377.40	26.57	95	8416	3559	46673992
Hypomagnesaemia	305.21	26.57	124	8387	22086	46655465
Stomatitis	244.44	26.57	153	8358	68144	46609407
Dry skin	232.52	26.57	124	8387	40892	46636659
Rash	230.27	26.57	302	8209	356210	46321341
Skin fissures	178.44	26.57	63	8448	7617	46669934
Colorectal cancer metastatic	177.61	26.57	38	8473	682	46676869
Neutropenia	160.92	26.57	162	8349	143042	46534509
Colon cancer	159.66	26.57	61	8450	9208	46668343
Colorectal cancer	151.16	26.57	35	8476	912	46676639
Disease progression	148.44	26.57	127	8384	91173	46586378
Diarrhoea	144.88	26.57	315	8196	559287	46118264
Neuropathy peripheral	126.89	26.57	116	8395	90777	46586774
Neurotoxicity	99.42	26.57	49	8462	13668	46663883
Skin disorder	97.83	26.57	57	8454	22206	46655345
Palmar-plantar erythrodysaesthesia syndrome	86.27	26.57	51	8460	20400	46657151
Neutrophil count decreased	82.08	26.57	66	8445	43360	46634191
Peripheral sensory neuropathy	80.86	26.57	34	8477	6569	46670982
Rash pustular	79.28	26.57	34	8477	6895	46670656
Metastases to liver	77.82	26.57	47	8464	19538	46658013
Mucosal inflammation	77.43	26.57	61	8450	38915	46638636
Drug ineffective	67.79	26.57	20	8491	677818	45999733
Hypertrichosis	65.97	26.57	18	8493	922	46676629
Skin reaction	64.46	26.57	34	8477	10912	46666639
Adenocarcinoma of colon	59.15	26.57	20	8491	2120	46675431
Malignant neoplasm progression	57.71	26.57	65	8446	64861	46612690
Xerosis	57.45	26.57	15	8496	648	46676903
Acne	57.29	26.57	39	8472	19880	46657671
Hypocalcaemia	49.08	26.57	40	8471	26745	46650806
Febrile neutropenia	48.30	26.57	72	8439	94555	46582996
Blood magnesium decreased	47.88	26.57	28	8483	10964	46666587
Hypokalaemia	46.40	26.57	68	8443	87956	46589595
Decreased appetite	43.88	26.57	104	8407	193732	46483819
Dehydration	43.26	26.57	92	8419	159448	46518103
Carcinoembryonic antigen increased	42.24	26.57	14	8497	1395	46676156
Thrombocytopenia	41.48	26.57	79	8432	126502	46551049
Polyneuropathy	41.30	26.57	26	8485	11618	46665933
Trichomegaly	40.91	26.57	7	8504	34	46677517
Fall	38.12	26.57	7	8504	329090	46348461
Conjunctivitis	36.92	26.57	27	8484	15397	46662154
Growth of eyelashes	36.01	26.57	8	8503	172	46677379
Anaemia	34.81	26.57	114	8397	255665	46421886
Ileus	34.53	26.57	25	8486	14039	46663512
Folliculitis	32.96	26.57	18	8493	6185	46671366
Gastrointestinal toxicity	32.95	26.57	16	8495	4315	46673236
Death	32.56	26.57	134	8377	335414	46342137
Arthralgia	32.42	26.57	13	8498	364590	46312961
Interstitial lung disease	31.83	26.57	44	8467	53905	46623646
Headache	31.20	26.57	25	8486	478327	46199224
Eye irritation	30.83	26.57	25	8486	16589	46660962
Erythema	29.47	26.57	74	8437	142746	46534805
Pain of skin	29.25	26.57	18	8493	7724	46669827
Haematotoxicity	28.46	26.57	17	8494	6916	46670635
Dermatitis	27.68	26.57	22	8489	14186	46663365

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
Dermatitis acneiform	1686.96	25.72	413	13339	5276	29933450
Paronychia	944.44	25.72	229	13523	2782	29935944
Skin toxicity	656.67	25.72	174	13578	3075	29935651
Hypomagnesaemia	556.25	25.72	228	13524	16370	29922356
Rash	418.92	25.72	475	13277	191414	29747312
Colorectal cancer	401.27	25.72	104	13648	1675	29937051
Stomatitis	324.92	25.72	206	13546	37073	29901653
Skin reaction	301.51	25.72	103	13649	4422	29934304
Rash pustular	265.34	25.72	96	13656	4887	29933839
Interstitial lung disease	252.92	25.72	214	13538	59983	29878743
Colon cancer	223.54	25.72	98	13654	8274	29930452
Dry skin	223.13	25.72	135	13617	22319	29916407
Colorectal cancer metastatic	218.29	25.72	57	13695	945	29937781
Disease progression	215.68	25.72	222	13530	79652	29859074
Diarrhoea	213.38	25.72	470	13282	333633	29605093
Metastases to liver	187.30	25.72	97	13655	11868	29926858
Acne	178.56	25.72	87	13665	9349	29929377
Neutropenia	166.91	25.72	247	13505	128293	29810433
Skin disorder	161.53	25.72	87	13665	11521	29927205
Neuropathy peripheral	158.61	25.72	178	13574	70297	29868429
Folliculitis	156.64	25.72	60	13692	3580	29935146
Mucosal inflammation	135.24	25.72	112	13640	30382	29908344
Decreased appetite	107.67	25.72	222	13530	149688	29789038
Skin fissures	107.39	25.72	45	13707	3394	29935332
Conjunctivitis	94.92	25.72	54	13698	7946	29930780
Neutrophil count decreased	89.89	25.72	104	13648	42350	29896376
Carcinoembryonic antigen increased	86.02	25.72	25	13727	625	29938101
Drug ineffective	84.27	25.72	26	13726	340361	29598365
Palmar-plantar erythrodysaesthesia syndrome	83.94	25.72	63	13689	14807	29923919
Metastases to lung	82.30	25.72	49	13703	7846	29930880
Hypocalcaemia	77.47	25.72	70	13682	21306	29917420
Peripheral sensory neuropathy	73.16	25.72	41	13711	5860	29932866
Xerosis	69.47	25.72	20	13732	483	29938243
Blood magnesium decreased	65.01	25.72	37	13715	5446	29933280
Neurotoxicity	61.70	25.72	50	13702	13132	29925594
Polyneuropathy	59.94	25.72	47	13705	11776	29926950
Therapy partial responder	52.25	25.72	28	13724	3663	29935063
Drug interaction	51.55	25.72	14	13738	199554	29739172
Thrombocytopenia	50.73	25.72	158	13594	136886	29801840
Headache	50.57	25.72	11	13741	182295	29756431
Erythema	49.98	25.72	110	13642	77341	29861385
Dermatitis	49.31	25.72	36	13716	8106	29930620
Ileus	48.76	25.72	47	13705	15508	29923218
Growth of eyelashes	47.73	25.72	10	13742	58	29938668
Dehydration	45.30	25.72	142	13610	123397	29815329
Metastases to pelvis	43.36	25.72	12	13740	250	29938476
Perioral dermatitis	42.50	25.72	10	13742	105	29938621
Catheter site thrombosis	41.70	25.72	8	13744	27	29938699
Febrile neutropenia	41.30	25.72	125	13627	106568	29832158
Hepatectomy	40.90	25.72	9	13743	68	29938658
Arthralgia	40.15	25.72	7	13745	135784	29802942
Carbohydrate antigen 19-9 increased	37.10	25.72	10	13742	188	29938538
Pulmonary embolism	36.50	25.72	98	13654	78037	29860689
Rectal cancer	35.05	25.72	18	13734	2158	29936568
Colorectal cancer recurrent	34.98	25.72	7	13745	31	29938695
Toxicity to various agents	34.86	25.72	19	13733	177164	29761562
Trichomegaly	34.24	25.72	6	13746	10	29938716
Gastrointestinal toxicity	33.48	25.72	17	13735	1991	29936735
Nail disorder	32.55	25.72	16	13736	1749	29936977
Fall	32.30	25.72	22	13730	181850	29756876
Livedo reticularis	31.98	25.72	17	13735	2187	29936539
Somnolence	30.86	25.72	4	13748	96759	29841967
Intestinal obstruction	30.85	25.72	41	13711	19171	29919555
Adenocarcinoma of colon	30.62	25.72	19	13733	3273	29935453
Metastases to lymph nodes	29.71	25.72	20	13732	3957	29934769
Ectropion	29.70	25.72	7	13745	74	29938652
Acne pustular	29.29	25.72	7	13745	79	29938647
Myocardial infarction	28.53	25.72	11	13741	125614	29813112
Epidermal naevus syndrome	28.29	25.72	5	13747	9	29938717
Pain in extremity	27.92	25.72	8	13744	110213	29828513
Colon cancer recurrent	27.09	25.72	7	13745	111	29938615
Dermatitis infected	27.09	25.72	7	13745	111	29938615
Product dose omission issue	26.47	25.72	5	13747	91626	29847100
Enterocolitis	26.40	25.72	23	13729	6664	29932062

Pharmacologic Action:

Source	Code	Description
ATC	L01XC08	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Monoclonal antibodies
FDA CS	M0001357	Antibodies, Monoclonal
FDA MoA	N0000020010	HER1 Antagonists
FDA EPC	N0000175664	Epidermal Growth Factor Receptor Antagonist
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D000074322	Antineoplastic Agents, Immunological

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Secondary malignant neoplasm of colon	indication	94260004

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
Epidermal growth factor receptor	Kinase	P00533	EGFR_HUMAN	AGONIST	Kd	10.30		IUPHAR	DRUG LABEL

External reference:

ID	Source
D05350	KEGG_DRUG
4025701	VUID
N0000179714	NUI
4025701	VANDF
C0879427	UMLSCUI
CHEMBL1201827	ChEMBL_ID
DB01269	DRUGBANK_ID
D000077544	MESH_DESCRIPTOR_UI
6883	IUPHAR_LIGAND_ID
8499	INN_ID
6A901E312A	UNII
263034	RXNORM
22205	MMSL
88497	MMSL
d05879	MMSL
011743	NDDF
423259008	SNOMEDCT_US
424401006	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Vectibix	HUMAN PRESCRIPTION DRUG LABEL	1	55513-954	SOLUTION	100 mg	INTRAVENOUS	BLA	28 sections
Vectibix	HUMAN PRESCRIPTION DRUG LABEL	1	55513-956	SOLUTION	400 mg	INTRAVENOUS	BLA	28 sections