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

Stem definition	Drug id	CAS RN
mouse origin	4915	853426-35-4

Description:

Molecule	Description
Synonyms: blinatumomab blincyto MEDI-538 MT-103	a single-chain bispecific recombinant antibody from Micromet's BiTE (bispecific T-cell engager) product platform that binds both the CD19 antigen and the T-cell receptor (CD3), for the potential treatment of B-cell lymphoma Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

blinatumomab
blincyto
MEDI-538
MT-103

a single-chain bispecific recombinant antibody from Micromet's BiTE (bispecific T-cell engager) product platform that binds both the CD19 antigen and the T-cell receptor (CD3), for the potential treatment of B-cell lymphoma

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

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company
Sept. 21, 2018	PMDA	Amgen Astellas Biopharma KK
Nov. 23, 2015	EMA	Amgen Europe B.V.
Dec. 3, 2014	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
Acute lymphocytic leukaemia recurrent	952.81	27.96	165	4753	1810	50598396
Cytokine release syndrome	710.04	27.96	165	4753	8469	50591737
Neurotoxicity	468.27	27.96	132	4786	14608	50585598
Pyrexia	307.56	27.96	269	4649	379934	50220272
Central nervous system leukaemia	128.83	27.96	20	4898	101	50600105
Leukaemic infiltration extramedullary	124.15	27.96	18	4900	51	50600155
Neoplasm recurrence	101.95	27.96	27	4891	2342	50597864
Acute lymphocytic leukaemia refractory	100.72	27.96	15	4903	54	50600152
Blast cell count increased	98.91	27.96	19	4899	377	50599829
Graft versus host disease in skin	86.00	27.96	24	4894	2532	50597674
Philadelphia chromosome positive	81.25	27.96	16	4902	363	50599843
Intercepted product preparation error	80.75	27.96	16	4902	375	50599831
Acute lymphocytic leukaemia	70.66	27.96	20	4898	2221	50597985
Febrile neutropenia	69.87	27.96	65	4853	97602	50502604
Babesiosis	69.85	27.96	13	4905	216	50599990
Leukaemia recurrent	67.10	27.96	17	4901	1237	50598969
Venoocclusive disease	64.69	27.96	18	4900	1878	50598328
Therapeutic response delayed	63.75	27.96	14	4904	547	50599659
Graft versus host disease	61.55	27.96	23	4895	6143	50594063
Seizure	54.41	27.96	62	4856	117812	50482394
Tumour lysis syndrome	50.56	27.96	21	4897	7400	50592806
Graft versus host disease in gastrointestinal tract	49.59	27.96	16	4902	2765	50597441
Escherichia bacteraemia	47.80	27.96	16	4902	3100	50597106
Aphasia	46.73	27.96	31	4887	28463	50571743
Venoocclusive liver disease	46.60	27.96	17	4901	4244	50595962
Transplantation complication	44.96	27.96	8	4910	102	50600104
Drug resistance	44.69	27.96	26	4892	18963	50581243
Infusion site haemorrhage	40.50	27.96	14	4904	2990	50597216
Transformation to acute myeloid leukaemia	40.47	27.96	8	4910	185	50600021
Therapy non-responder	40.42	27.96	36	4882	50986	50549220
Nervous system disorder	40.27	27.96	23	4895	16200	50584006
Device related infection	40.02	27.96	25	4893	20710	50579496
Jaw operation	38.91	27.96	10	4908	770	50599436
Neutropenia	38.87	27.96	59	4859	147906	50452300
Hypoproteinaemia	38.73	27.96	12	4906	1819	50598387
Hepatotoxicity	38.42	27.96	27	4891	27199	50573007
Accidental exposure to product	37.60	27.96	25	4893	23032	50577174
Leukoencephalopathy	33.41	27.96	13	4905	3870	50596336
Leukaemic infiltration renal	33.15	27.96	5	4913	20	50600186
Neurological symptom	31.32	27.96	13	4905	4569	50595637

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
Cytokine release syndrome	706.23	24.67	211	6132	12908	29555276
Acute lymphocytic leukaemia recurrent	612.47	24.67	135	6208	2381	29565803
Neurotoxicity	332.66	24.67	123	6220	14490	29553694
Pyrexia	327.74	24.67	351	5992	287271	29280913
Blast cell count increased	174.85	24.67	41	6302	956	29567228
Central nervous system leukaemia	145.71	24.67	28	6315	237	29567947
Leukaemic infiltration extramedullary	118.48	24.67	20	6323	72	29568112
Acute lymphocytic leukaemia refractory	96.02	24.67	17	6326	86	29568098
Minimal residual disease	81.10	24.67	18	6325	325	29567859
Aphasia	64.48	24.67	44	6299	19154	29549030
Tremor	64.37	24.67	79	6264	73459	29494725
Acute lymphocytic leukaemia	62.88	24.67	23	6320	2608	29565576
Cytopenia	59.86	24.67	33	6310	9826	29558358
Nervous system disorder	54.69	24.67	34	6309	12640	29555544
Device related infection	50.52	24.67	35	6308	15601	29552583
Aspiration bone marrow abnormal	50.08	24.67	10	6333	105	29568079
Product preparation error	49.08	24.67	17	6326	1645	29566539
Encephalopathy	47.76	24.67	45	6298	30998	29537186
Metastases to muscle	43.57	24.67	10	6333	211	29567973
Metastases to retroperitoneum	43.31	24.67	10	6333	217	29567967
Therapy non-responder	42.27	24.67	42	6301	30869	29537315
Graft versus host disease	41.97	24.67	26	6317	9602	29558582
Hepatotoxicity	41.95	24.67	33	6310	17834	29550350
Neurological symptom	40.62	24.67	18	6325	3352	29564832
Metastases to bone marrow	40.45	24.67	11	6332	471	29567713
Febrile neutropenia	40.40	24.67	80	6263	112160	29456024
Accidental exposure to product	39.34	24.67	26	6317	10727	29557457
Personality change due to a general medical condition	38.52	24.67	7	6336	42	29568142
Metastases to spleen	38.19	24.67	10	6333	370	29567814
Graft versus host disease in skin	37.38	24.67	17	6326	3362	29564822
Infusion site haemorrhage	36.09	24.67	11	6332	709	29567475
Blast cells present	35.65	24.67	10	6333	481	29567703
Confusional state	33.29	24.67	80	6263	127797	29440387
Incorrect drug administration rate	30.79	24.67	11	6332	1165	29567019
Tumour lysis syndrome	29.10	24.67	24	6319	13860	29554324
Off label use	27.38	24.67	132	6211	300668	29267516
Apraxia	26.88	24.67	10	6333	1188	29566996
Leukoencephalopathy	26.75	24.67	14	6329	3753	29564431
Neoplasm progression	26.75	24.67	26	6317	18586	29549598
Intercepted product preparation error	26.72	24.67	12	6331	2305	29565879
Serum ferritin increased	26.68	24.67	16	6327	5572	29562612
Systemic mycosis	25.93	24.67	10	6333	1311	29566873
Fall	25.09	24.67	4	6339	177174	29391010
Mental status changes	24.98	24.67	34	6309	34893	29533291
Hepatic calcification	24.95	24.67	7	6336	337	29567847
Adrenomegaly	24.69	24.67	7	6336	350	29567834

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
Acute lymphocytic leukaemia recurrent	1249.61	23.81	251	10084	3775	64484622
Cytokine release syndrome	1098.09	23.81	309	10026	20520	64467877
Neurotoxicity	516.78	23.81	186	10149	27218	64461179
Pyrexia	472.11	23.81	508	9827	558136	63930261
Central nervous system leukaemia	219.12	23.81	40	10295	345	64488052
Blast cell count increased	197.93	23.81	45	10290	1234	64487163
Leukaemic infiltration extramedullary	181.46	23.81	30	10305	133	64488264
Acute lymphocytic leukaemia refractory	149.41	23.81	25	10310	121	64488276
Acute lymphocytic leukaemia	118.54	23.81	39	10296	4332	64484065
Febrile neutropenia	117.01	23.81	147	10188	187510	64300887
Graft versus host disease in skin	110.84	23.81	39	10296	5308	64483089
Graft versus host disease	92.85	23.81	45	10290	13768	64474629
Nervous system disorder	91.93	23.81	53	10282	23025	64465372
Aphasia	88.55	23.81	64	10271	40842	64447555
Therapy non-responder	86.76	23.81	77	10258	65822	64422575
Device related infection	78.14	23.81	53	10282	30573	64457824
Intercepted product preparation error	76.70	23.81	23	10312	1885	64486512
Infusion site haemorrhage	76.47	23.81	24	10311	2291	64486106
Neoplasm recurrence	76.45	23.81	27	10308	3712	64484685
Philadelphia chromosome positive	75.79	23.81	18	10317	599	64487798
Tremor	73.65	23.81	104	10231	148126	64340271
Minimal residual disease	71.73	23.81	16	10319	401	64487996
Cytopenia	71.02	23.81	39	10296	15432	64472965
Graft versus host disease in gastrointestinal tract	65.79	23.81	27	10308	5585	64482812
Venoocclusive disease	63.70	23.81	24	10311	3961	64484436
Tumour lysis syndrome	62.74	23.81	39	10296	19401	64468996
Babesiosis	60.43	23.81	13	10322	274	64488123
Leukaemia recurrent	54.06	23.81	19	10316	2575	64485822
Leukoencephalopathy	53.86	23.81	25	10310	6942	64481455
Hepatotoxicity	53.17	23.81	47	10288	39915	64448482
Venoocclusive liver disease	50.85	23.81	27	10308	9988	64478409
Therapeutic response delayed	50.49	23.81	14	10321	868	64487529
Escherichia bacteraemia	50.06	23.81	22	10313	5381	64483016
Neutropenia	47.64	23.81	113	10222	239511	64248886
Seizure	46.16	23.81	90	10245	166802	64321595
Product preparation error	46.03	23.81	19	10316	3986	64484411
Leukaemic infiltration renal	44.73	23.81	7	10328	20	64488377
Encephalopathy	44.62	23.81	51	10284	58768	64429629
Metastases to muscle	42.60	23.81	10	10325	316	64488081
Blast cells present	41.94	23.81	12	10323	834	64487563
Metastases to retroperitoneum	41.26	23.81	10	10325	363	64488034
Off label use	41.24	23.81	205	10130	632601	63855796
Pancytopenia	40.49	23.81	78	10257	143231	64345166
Metastases to bone marrow	40.07	23.81	11	10324	657	64487740
Metastases to spleen	38.24	23.81	10	10325	496	64487901
Neurological symptom	36.25	23.81	19	10316	6845	64481552
Disseminated intravascular coagulation	35.18	23.81	34	10301	32314	64456083
Fusarium infection	34.65	23.81	12	10323	1557	64486840
Fall	34.34	23.81	12	10323	416814	64071583
Jaw operation	34.22	23.81	10	10325	749	64487648
Transformation to acute myeloid leukaemia	32.98	23.81	10	10325	851	64487546
Disease progression	32.77	23.81	71	10264	141609	64346788
Apraxia	32.67	23.81	13	10322	2482	64485915
Personality change due to a general medical condition	32.56	23.81	7	10328	147	64488250
Serum ferritin increased	32.52	23.81	19	10316	8449	64479948
Neutrophil count decreased	32.28	23.81	50	10285	77146	64411251
Neoplasm progression	31.88	23.81	36	10299	40928	64447469
Blood lactate dehydrogenase increased	30.87	23.81	32	10303	33046	64455351
Precursor B-lymphoblastic lymphoma recurrent	30.27	23.81	5	10330	22	64488375
Platelet count decreased	30	23.81	76	10259	167635	64320762
Diarrhoea	29.48	23.81	44	10291	722660	63765737
Cytomegalovirus infection	29.47	23.81	33	10302	37166	64451231
Transaminases increased	29.40	23.81	36	10299	44558	64443839
Accidental exposure to product	29.21	23.81	28	10307	26336	64462061
Capillary leak syndrome	29.18	23.81	13	10322	3284	64485113
Trichosporon infection	28.43	23.81	9	10326	883	64487514
Acute graft versus host disease in skin	27.97	23.81	16	10319	6839	64481558
Blood bilirubin increased	27.96	23.81	40	10295	57513	64430884
White blood cell count increased	27.93	23.81	43	10292	65971	64422426
Drug resistance	27.57	23.81	31	10304	35071	64453326
Drug hypersensitivity	27.54	23.81	3	10332	237812	64250585
Pruritus	27.47	23.81	8	10327	312392	64176005
Bone marrow failure	27.32	23.81	36	10299	47916	64440481
Aspiration bone marrow abnormal	27.27	23.81	6	10329	141	64488256
Dyspnoea	27.18	23.81	46	10289	718628	63769769
Systemic mycosis	26.63	23.81	11	10324	2312	64486085
Hepatic calcification	26.57	23.81	7	10328	357	64488040
Adrenomegaly	26.29	23.81	7	10328	372	64488025
Hypoproteinaemia	25.72	23.81	12	10323	3370	64485027
Chronic graft versus host disease oral	25.51	23.81	5	10330	65	64488332
Interleukin level increased	25.48	23.81	7	10328	419	64487978
Haemolytic transfusion reaction	25.17	23.81	4	10331	13	64488384
Confusional state	24.87	23.81	95	10240	261049	64227348
Chronic graft versus host disease in skin	24.51	23.81	9	10326	1382	64487015
Pain	24.23	23.81	32	10303	553479	63934918
Escherichia urinary tract infection	24.14	23.81	18	10317	12019	64476378
Condition aggravated	24.06	23.81	15	10320	372411	64115986
Costal cartilage fracture	23.98	23.81	6	10329	249	64488148
Fatigue	23.89	23.81	53	10282	748677	63739720

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01FX07	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES Other monoclonal antibodies and antibody drug conjugates
FDA CS	M0018640	Recombinant Fusion Proteins
MeSH PA	D000970	Antineoplastic Agents
FDA MoA	N0000175617	CD3-directed Antibody Interactions
FDA MoA	N0000175618	CD3 Receptor Agonists
FDA EPC	N0000191421	Bispecific CD19-directed CD3-directed T Cell Engager
FDA MoA	N0000191422	CD19-directed Antibody Interactions

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

Disease	Relation	SNOMED_ID	DOID
Pre B-cell acute lymphoblastic leukemia	indication	277572006

🐶 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
B-lymphocyte antigen CD19	Surface antigen	P15391	CD19_HUMAN	ANTIBODY BINDING	Kd	9		IUPHAR	DRUG LABEL
T-cell surface glycoprotein CD3	Surface antigen	P07766 P09693 P04234	CD3E_HUMAN CD3G_HUMAN CD3D_HUMAN	ANTIBODY BINDING	Kd	7		IUPHAR	DRUG LABEL

External reference:

ID	Source
4FR53SIF3A	UNII
D09325	KEGG_DRUG
4033958	VUID
N0000191284	NUI
4033958	VANDF
C3853839	UMLSCUI
CHEMBL1742992	ChEMBL_ID
DB09052	DRUGBANK_ID
9028	INN_ID
C510808	MESH_SUPPLEMENTAL_RECORD_UI
7384	IUPHAR_LIGAND_ID
C568788	MESH_SUPPLEMENTAL_RECORD_UI
1597258	RXNORM
231126	MMSL
30709	MMSL
d08312	MMSL
015799	NDDF
716122004	SNOMEDCT_US
774173007	SNOMEDCT_US

Pharmaceutical products:

None