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

Stem definition	Drug id	CAS RN
humanized origin	5055	1362509-93-0

Description:

Molecule

Description

Synonyms:

idarucizumab
praxbind
BI 655075
BI-655075

an anticoagulant reversal agent that targets dabigatran

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
Nov. 20, 2015	EMA	Boehringer Ingelheim International GmbH
Oct. 16, 2015	FDA	BOEHRINGER INGELHEIM

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
Haemorrhage	116.82	76.60	39	741	60983	63427259
Death	98.10	76.60	59	721	374322	63113920
Cerebral haemorrhage	97.81	76.60	29	751	30700	63457542
Multiple organ dysfunction syndrome	95.66	76.60	33	747	56719	63431523

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
Cerebral haemorrhage	105.50	58.80	41	1164	34896	34920830
Haemorrhage	90.25	58.80	41	1164	51329	34904397
Haemorrhage intracranial	63.64	58.80	23	1182	15923	34939803
Death	62.53	58.80	72	1133	397977	34557749
Gastrointestinal haemorrhage	58.88	58.80	37	1168	88440	34867286

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
Cerebral haemorrhage	184.10	59.17	65	1957	57608	79684758
Haemorrhage	172.23	59.17	70	1952	91048	79651318
Death	124.40	59.17	107	1915	566407	79175959
Haemorrhage intracranial	112.74	59.17	37	1985	26156	79716210
Multiple organ dysfunction syndrome	110.74	59.17	56	1966	120190	79622176
Shock haemorrhagic	105.46	59.17	33	1989	20027	79722339
Gastrointestinal haemorrhage	94.47	59.17	54	1968	147665	79594701
Cerebral infarction	89.18	59.17	36	1986	45640	79696726
Haemorrhagic transformation stroke	88.11	59.17	19	2003	2673	79739693
Ischaemic stroke	74.74	59.17	29	1993	33102	79709264
Subdural haematoma	69.08	59.17	27	1995	31407	79710959

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	V03AB37	VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Antidotes
FDA CS	M0556300	Antibodies, Monoclonal, Humanized
FDA EPC	N0000191873	Humanized Monoclonal Antibody Fragment

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

Disease	Relation	SNOMED_ID	DOID
Drug-induced coagulation inhibitor disorder	indication	16773005

🐶 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:

None

External reference:

ID	Source
97RWB5S1U6	UNII
D10741	KEGG_DRUG
4034988	VANDF
C3885063	UMLSCUI
CHEMBL3544996	ChEMBL_ID
DB09264	DRUGBANK_ID
9698	INN_ID
C000594745	MESH_SUPPLEMENTAL_RECORD_UI
8298	IUPHAR_LIGAND_ID
1716191	RXNORM
236513	MMSL
31242	MMSL
d08387	MMSL
016531	NDDF
716017002	SNOMEDCT_US
763599002	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Praxbind	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0197	INJECTION	50 mg	INTRAVENOUS	BLA	24 sections