All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

emicizumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Drug dosage:

Dose	Unit	Route
15	mg	P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

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

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
Off label use	257.88	131.19	102	203	1102150	89525992
No adverse event	240.69	131.19	53	252	67929	90560213

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
Haemorrhage	2072.15	37.61	613	5163	59950	42555609
Haemarthrosis	1590.70	37.61	298	5478	3700	42611859
No adverse event	920.35	37.61	299	5477	38722	42576837
Muscle haemorrhage	399.36	37.61	96	5680	4029	42611530
Traumatic haemorrhage	356.80	37.61	71	5705	1206	42614353
Fall	150.24	37.61	171	5605	234349	42381210
Activated partial thromboplastin time prolonged	148.74	37.61	62	5714	15841	42599718
Injury	143.95	37.61	67	5709	22249	42593310
Spontaneous haemorrhage	143.73	37.61	29	5747	528	42615031
Drug specific antibody present	141.33	37.61	42	5734	3964	42611595
Anti factor VIII antibody positive	131.12	37.61	21	5755	90	42615469
Haematoma	126.58	37.61	66	5710	27957	42587602
Off label use	123.32	37.61	267	5509	638068	41977491
Factor VIII inhibition	121.24	37.61	23	5753	299	42615260
Head injury	118.03	37.61	57	5719	20525	42595034
Contusion	89.66	37.61	61	5715	41924	42573635
Haemophilic arthropathy	82.07	37.61	16	5760	242	42615317
Anti factor VIII antibody increased	82.05	37.61	12	5764	23	42615536
Injection site reaction	76.63	37.61	39	5737	15682	42599877
Post procedural haemorrhage	76.06	37.61	33	5743	9279	42606280
Arthralgia	75.28	37.61	114	5662	205124	42410435
Haematoma muscle	73.47	37.61	22	5754	2128	42613431
Joint injury	70.34	37.61	36	5740	14640	42600919
Inhibiting antibodies	63.54	37.61	9	5767	12	42615547
Limb injury	62.56	37.61	33	5743	14272	42601287
Haemorrhage intracranial	62.26	37.61	35	5741	17157	42598402
Haemorrhage subcutaneous	60.82	37.61	20	5756	2626	42612933
Mouth haemorrhage	57.11	37.61	24	5752	6237	42609322
Epistaxis	53.45	37.61	55	5721	66771	42548788
Ligament sprain	51.07	37.61	20	5756	4338	42611221
Haematuria	48.82	37.61	49	5727	57750	42557809
Haemophilic pseudotumour	47.44	37.61	6	5770	0	42615559
Gingival bleeding	41.19	37.61	21	5755	8464	42607095
Intermenstrual bleeding	39.54	37.61	5	5771	0	42615559
Joint swelling	38.90	37.61	47	5729	67975	42547584
Joint microhaemorrhage	38.85	37.61	7	5769	67	42615492

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
Haemorrhage	1824	35.41	493	4445	106199	110478162
Haemarthrosis	1396.32	35.41	247	4691	7082	110577279
No adverse event	780.78	35.41	236	4702	73603	110510758
Muscle haemorrhage	433.90	35.41	92	4846	6777	110577584
Traumatic haemorrhage	329.33	35.41	59	4879	1785	110582576
Off label use	207.14	35.41	290	4648	1499895	109084466
Activated partial thromboplastin time prolonged	199.49	35.41	63	4875	22305	110562056
Head injury	155.70	35.41	62	4876	42955	110541406
Anti factor VIII antibody positive	146.47	35.41	20	4918	89	110584272
Haematoma	134.18	35.41	61	4877	58415	110525946
Drug specific antibody present	119.59	35.41	34	4904	8400	110575961
Spontaneous haemorrhage	116.38	35.41	23	4915	1185	110583176
Fall	109.06	35.41	134	4804	603348	109981013
Factor VIII inhibition	108.93	35.41	18	4920	332	110584029
Inhibiting antibodies	73.53	35.41	9	4929	12	110584349
Haemophilic arthropathy	73.48	35.41	12	4926	205	110584156
Haematuria	68.73	35.41	44	4894	82961	110501400
Anti factor VIII antibody increased	67.30	35.41	9	4929	33	110584328
Limb injury	67.04	35.41	33	4905	37603	110546758
Haemorrhage subcutaneous	63.77	35.41	19	4919	5520	110578841
Joint injury	62.23	35.41	32	4906	39962	110544399
Injury	61.72	35.41	56	4882	177209	110407152
Haematoma muscle	60.28	35.41	17	4921	4073	110580288
Haemorrhage intracranial	59.46	35.41	28	4910	28941	110555420
Post procedural haemorrhage	58.31	35.41	23	4915	15489	110568872
Epistaxis	55.07	35.41	46	4892	130326	110454035
Mouth haemorrhage	50.70	35.41	20	4918	13468	110570893
Gingival bleeding	46.41	35.41	21	4917	19818	110564543
Haemophilic pseudotumour	45.09	35.41	5	4933	0	110584361
Gastrointestinal haemorrhage	43.83	35.41	45	4893	165473	110418888
Intra-abdominal haemorrhage	39.23	35.41	13	4925	5329	110579032
Cerebral haemorrhage	38.45	35.41	28	4910	64940	110519421
Contusion	37.43	35.41	49	4889	233312	110351049

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

Related Drugs by ATC class:

B02BX Other systemic hemostatics 10 drugs

avatrombopagcarbazochromeconcizumabeltrombopagetamsylatefitusiranfostamatiniblusutrombopagmarstacimab-hncqromiplostim

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:

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

External reference:

ID	Source
7NL2E3F6K3	UNII
4037121	VANDF
4037122	VANDF
C4278463	UMLSCUI
CHEBI:755960	CHEBI
CHEMBL3833393	ChEMBL_ID
DB13923	DRUGBANK_ID
D10821	KEGG_DRUG
10115	INN_ID
C000608208	MESH_SUPPLEMENTAL_RECORD_UI
9744	IUPHAR_LIGAND_ID
763611007	SNOMEDCT_US
763612000	SNOMEDCT_US
265731	MMSL
33262	MMSL
33390	MMSL
d08677	MMSL
017412	NDDF
1989794	RXNORM

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Hemlibra	HUMAN PRESCRIPTION DRUG LABEL	1	50242-920	INJECTION, SOLUTION	30 mg	SUBCUTANEOUS	BLA	29 sections
Hemlibra	HUMAN PRESCRIPTION DRUG LABEL	1	50242-921	INJECTION, SOLUTION	60 mg	SUBCUTANEOUS	BLA	29 sections
Hemlibra	HUMAN PRESCRIPTION DRUG LABEL	1	50242-922	INJECTION, SOLUTION	105 mg	SUBCUTANEOUS	BLA	29 sections
Hemlibra	HUMAN PRESCRIPTION DRUG LABEL	1	50242-923	INJECTION, SOLUTION	150 mg	SUBCUTANEOUS	BLA	29 sections
Hemlibra	HUMAN PRESCRIPTION DRUG LABEL	1	50242-927	INJECTION, SOLUTION	12 mg	SUBCUTANEOUS	BLA	29 sections
Hemlibra	HUMAN PRESCRIPTION DRUG LABEL	1	50242-930	INJECTION, SOLUTION	300 mg	SUBCUTANEOUS	BLA	29 sections