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

Stem definition	Drug id	CAS RN
human origin	4965	615258-40-7

Description:

Molecule	Description
Synonyms: denosumab prolia AMG 162 AMG162	A humanized monoclonal antibody and an inhibitor of the RANK LIGAND, which regulates OSTEOCLAST differentiation and bone remodeling. It is used as a BONE DENSITY CONSERVATION AGENT in the treatment of OSTEOPOROSIS. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

denosumab
prolia
AMG 162
AMG162

A humanized monoclonal antibody and an inhibitor of the RANK LIGAND, which regulates OSTEOCLAST differentiation and bone remodeling. It is used as a BONE DENSITY CONSERVATION AGENT in the treatment of OSTEOPOROSIS.

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

Drug dosage:

Dose	Unit	Route
0.33	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
June 1, 2010	FDA	AMGEN
May 26, 2010	EMA	Amgen Europe B.V.

FDA Adverse Event Reporting System (Female)

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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
Off label use	44255.26	11.30	27558	192774	646904	62621786
Osteonecrosis of jaw	11079.95	11.30	4271	216061	30852	63237838
Death	5901.30	11.30	6846	213486	367535	62901155
Spinal fracture	2579.15	11.30	1262	219070	17009	63251681
Bone pain	2079.58	11.30	1634	218698	53007	63215683
Hypocalcaemia	1917.46	11.30	1257	219075	30456	63238234
Tooth disorder	1825.14	11.30	1166	219166	26991	63241699
Atypical femur fracture	1519.68	11.30	605	219727	4767	63263923
Pain in jaw	1472.48	11.30	1215	219117	42281	63226409
Drug ineffective	1379.74	11.30	980	219352	1043785	62224905

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FDA Adverse Event Reporting System (Male)

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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
Osteonecrosis of jaw	7799.88	14.01	2170	42211	15719	34896831
Off label use	3540.73	14.01	3405	40976	416119	34496431
Hypocalcaemia	1898.09	14.01	817	43564	23472	34889078
Death	1820.65	14.01	2359	42022	395690	34516860
Terminal state	569.40	14.01	207	44174	3727	34908823
Prostatic specific antigen increased	405.36	14.01	245	44136	14435	34898115
Metastases to bone	372.96	14.01	216	44165	11754	34900796
Tooth extraction	303.98	14.01	139	44242	4589	34907961
Tooth disorder	298.79	14.01	181	44200	10701	34901849
Malignant neoplasm progression	274.52	14.01	439	43942	87607	34824943

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FDA Adverse Event Reporting System (Geriatric)

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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
Off label use	25747.47	11.32	20240	194722	886975	78642451
Osteonecrosis of jaw	14195.32	11.32	5060	209902	38166	79491260
Death	6161.63	11.32	7570	207392	558944	78970482
Hypocalcaemia	2498.10	11.32	1599	213363	48325	79481101
Bone pain	1813.92	11.32	1371	213591	54371	79475055
Tooth disorder	1697.99	11.32	991	213971	25242	79504184
Spinal fracture	1571.48	11.32	829	214133	17225	79512201
Atypical femur fracture	1407.36	11.32	529	214433	4660	79524766
Pain in jaw	1371.94	11.32	1076	213886	45075	79484351
Tooth extraction	1329.22	11.32	631	214331	10364	79519062

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	M05BX04	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Other drugs affecting bone structure and mineralization
FDA EPC	N0000187055	RANK Ligand Inhibitor
FDA MoA	N0000187054	RANK Ligand Blocking Activity
MeSH PA	D050071	Bone Density Conservation Agents

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

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Disease	Relation	SNOMED_ID	DOID
Drug-induced osteoporosis	indication	14651005
Osteoporosis	indication	64859006	DOID:11476
Postmenopausal osteoporosis	indication	102447009

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🐶 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:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Tumor necrosis factor ligand superfamily member 11	Cytokine	O14788	TNF11_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL

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External reference:

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ID	Source
013441	NDDF
173191	MMSL
27218	MMSL
4030131	VUID
4030131	VANDF
446321003	SNOMEDCT_US
446457007	SNOMEDCT_US
4EQZ6YO2HI	UNII
6886	IUPHAR_LIGAND_ID
8653	INN_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Prolia	HUMAN PRESCRIPTION DRUG LABEL	1	55513-710	INJECTION	60 mg	SUBCUTANEOUS	BLA	34 sections
Prolia	HUMAN PRESCRIPTION DRUG LABEL	1	55513-710	INJECTION	60 mg	SUBCUTANEOUS	BLA	34 sections
Prolia	HUMAN PRESCRIPTION DRUG LABEL	1	55513-710	INJECTION	60 mg	SUBCUTANEOUS	BLA	34 sections
XGEVA	HUMAN PRESCRIPTION DRUG LABEL	1	55513-730	INJECTION	120 mg	SUBCUTANEOUS	BLA	29 sections
XGEVA	HUMAN PRESCRIPTION DRUG LABEL	1	55513-730	INJECTION	120 mg	SUBCUTANEOUS	BLA	29 sections
XGEVA	HUMAN PRESCRIPTION DRUG LABEL	1	55513-730	INJECTION	120 mg	SUBCUTANEOUS	BLA	29 sections

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