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

Stem definition	Drug id	CAS RN
humanized origin	5268	1610943-06-0

Description:

Molecule	Description
Molfile Synonyms: emicizumab emicizumab-kxwh hemlibra ACE910 emicizumab (genetical recombination)	Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) antibody with a bispecific antibody structure binding factor IXa and factor X. Emicizumab-kxwh has an approximate molecular weight of 145.6 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII. Emicizumab-kxwh bridges activated factor IX and factor X to restore the function of missing activated factor VIII that is needed for effective hemostasis. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Molfile

Synonyms:

emicizumab
emicizumab-kxwh
hemlibra
ACE910
emicizumab (genetical recombination)

Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) antibody with a bispecific antibody structure binding factor IXa and factor X. Emicizumab-kxwh has an approximate molecular weight of 145.6 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Emicizumab-kxwh has no structural relationship or sequence homology to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII. Emicizumab-kxwh bridges activated factor IX and factor X to restore the function of missing activated factor VIII that is needed for effective hemostasis.

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

Drug dosage:

Dose	Unit	Route
15	mg	P

ADMET properties:

None

Approvals:

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Date	Agency	Company
Feb. 23, 2018	EMA	Roche Registration Limited
March 23, 2018	PMDA	Chugai Pharmaceutical Co., Ltd.
Nov. 16, 2017	FDA	GENENTECH INC

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FDA Adverse Event Reporting System (Female)

None

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
Haemarthrosis	1104.88	46.28	189	2065	3070	34951607
Haemorrhage	704.34	46.28	217	2037	51153	34903524
Muscle haemorrhage	255.82	46.28	57	2197	3661	34951016
No adverse event	131.61	46.28	51	2203	22876	34931801
Traumatic haemorrhage	111.63	46.28	22	2232	769	34953908
Drug specific antibody present	80.47	46.28	22	2232	3263	34951414
Activated partial thromboplastin time prolonged	78.33	46.28	27	2227	8668	34946009
Arthralgia	65.94	46.28	67	2187	169974	34784703
Factor VIII inhibition	64.22	46.28	12	2242	314	34954363
Haematoma	55.93	46.28	29	2225	25576	34929101

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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
Haemarthrosis	918.81	42.80	151	1662	5661	79736914
Haemorrhage	535.80	42.80	158	1655	90960	79651615
Muscle haemorrhage	273.27	42.80	55	1758	6245	79736330
Activated partial thromboplastin time prolonged	92.98	42.80	27	1786	14201	79728374
Traumatic haemorrhage	71.98	42.80	14	1799	1319	79741256
No adverse event	71.05	42.80	28	1785	37164	79705411
Factor VIII inhibition	68.97	42.80	11	1802	327	79742248
Anti factor VIII antibody positive	66.13	42.80	9	1804	85	79742490
Drug specific antibody present	63.51	42.80	17	1796	6635	79735940
Haematoma	52.54	42.80	25	1788	52170	79690405

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	B02BX06	BLOOD AND BLOOD FORMING ORGANS ANTIHEMORRHAGICS VITAMIN K AND OTHER HEMOSTATICS Other systemic hemostatics

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

Disease	Relation	SNOMED_ID	DOID
Hereditary factor VIII deficiency disease	indication	28293008	DOID:12134

🐶 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
Coagulation factor X	Enzyme	P00742	FA10_HUMAN	ANTIBODY BINDING	Kd	5.73		IUPHAR
Coagulation factor IX	Enzyme	P00740	FA9_HUMAN	ANTIBODY BINDING	Kd	5.80		IUPHAR

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External reference:

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ID	Source
017412	NDDF
10115	INN_ID
1989794	RXNORM
265731	MMSL
33262	MMSL
33390	MMSL
4037121	VANDF
4037122	VANDF
763611007	SNOMEDCT_US
763612000	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Hemlibra	HUMAN PRESCRIPTION DRUG LABEL	1	50242-920	INJECTION, SOLUTION	30 mg	SUBCUTANEOUS	BLA	31 sections
Hemlibra	HUMAN PRESCRIPTION DRUG LABEL	1	50242-920	INJECTION, SOLUTION	30 mg	SUBCUTANEOUS	BLA	31 sections
Hemlibra	HUMAN PRESCRIPTION DRUG LABEL	1	50242-920	INJECTION, SOLUTION	30 mg	SUBCUTANEOUS	BLA	31 sections
Hemlibra	HUMAN PRESCRIPTION DRUG LABEL	1	50242-921	INJECTION, SOLUTION	150 mg	SUBCUTANEOUS	BLA	31 sections
Hemlibra	HUMAN PRESCRIPTION DRUG LABEL	1	50242-921	INJECTION, SOLUTION	150 mg	SUBCUTANEOUS	BLA	31 sections
Hemlibra	HUMAN PRESCRIPTION DRUG LABEL	1	50242-921	INJECTION, SOLUTION	60 mg	SUBCUTANEOUS	BLA	31 sections
Hemlibra	HUMAN PRESCRIPTION DRUG LABEL	1	50242-922	INJECTION, SOLUTION	105 mg	SUBCUTANEOUS	BLA	31 sections
Hemlibra	HUMAN PRESCRIPTION DRUG LABEL	1	50242-922	INJECTION, SOLUTION	150 mg	SUBCUTANEOUS	BLA	31 sections
Hemlibra	HUMAN PRESCRIPTION DRUG LABEL	1	50242-922	INJECTION, SOLUTION	150 mg	SUBCUTANEOUS	BLA	31 sections
Hemlibra	HUMAN PRESCRIPTION DRUG LABEL	1	50242-923	INJECTION, SOLUTION	150 mg	SUBCUTANEOUS	BLA	31 sections

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