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	1163.24	27.78	198	5632	2071	63481121
Cytokine release syndrome	974.16	27.78	232	5598	14082	63469110
Neurotoxicity	542.94	27.78	151	5679	16839	63466353
Pyrexia	368.66	27.78	319	5511	470159	63013033
Central nervous system leukaemia	202.11	27.78	30	5800	113	63483079
Leukaemic infiltration extramedullary	169.66	27.78	24	5806	58	63483134
Blast cell count increased	116.38	27.78	22	5808	424	63482768
Acute lymphocytic leukaemia refractory	106.04	27.78	16	5814	69	63483123
Neoplasm recurrence	100.57	27.78	27	5803	2611	63480581
Graft versus host disease in skin	97.99	27.78	27	5803	2878	63480314
Intercepted product preparation error	94.99	27.78	20	5810	677	63482515
Acute lymphocytic leukaemia	87.72	27.78	24	5806	2492	63480700
Philadelphia chromosome positive	87.14	27.78	17	5813	389	63482803
Febrile neutropenia	86.93	27.78	78	5752	118371	63364821
Venoocclusive disease	78.15	27.78	21	5809	2037	63481155
Graft versus host disease	75.53	27.78	27	5803	6736	63476456
Seizure	72.03	27.78	74	5756	132560	63350632
Babesiosis	70.58	27.78	13	5817	216	63482976
Leukaemia recurrent	66.96	27.78	17	5813	1321	63481871
Therapeutic response delayed	62.19	27.78	14	5816	650	63482542
Aphasia	61.24	27.78	38	5792	32962	63450230
Tumour lysis syndrome	61.14	27.78	25	5805	8965	63474227
Venoocclusive liver disease	56.63	27.78	20	5810	4815	63478377
Graft versus host disease in gastrointestinal tract	56.17	27.78	18	5812	3223	63479969
Tremor	54.75	27.78	64	5766	132175	63351017
Nervous system disorder	54.66	27.78	29	5801	18737	63464455
CSF cell count increased	53.91	27.78	8	5822	30	63483162
Transplantation complication	49.24	27.78	9	5821	143	63483049
Escherichia bacteraemia	45.24	27.78	16	5814	3867	63479325
Neutropenia	44.95	27.78	67	5763	174938	63308254
Jaw operation	43.49	27.78	11	5819	841	63482351
Leukoencephalopathy	43.24	27.78	16	5814	4397	63478795
Drug resistance	41.50	27.78	26	5804	22907	63460285
Accidental exposure to product	39.64	27.78	27	5803	27378	63455814
Device related infection	38.55	27.78	25	5805	23367	63459825
Transformation to acute myeloid leukaemia	38.45	27.78	8	5822	255	63482937
Product preparation error	38.24	27.78	16	5814	6076	63477116
Hypoproteinaemia	38.07	27.78	12	5818	2037	63481155
Minimal residual disease	36.92	27.78	7	5823	137	63483055
Acute graft versus host disease	35.97	27.78	14	5816	4414	63478778
Hepatotoxicity	34.48	27.78	28	5802	37013	63446179
Infusion site haemorrhage	34.09	27.78	14	5816	5072	63478120
Pain	33.76	27.78	13	5817	740615	62742577
Leukaemic infiltration renal	33.44	27.78	5	5825	20	63483172
Immune effector cell-associated neurotoxicity syndrome	32.81	27.78	11	5819	2266	63480926
Neurological symptom	32.35	27.78	14	5816	5769	63477423
Acute graft versus host disease in skin	31.93	27.78	12	5818	3440	63479752
Therapy non-responder	31.81	27.78	37	5793	75864	63407328
Neutrophil count decreased	31.51	27.78	32	5798	56374	63426818
Sepsis	30.19	27.78	52	5778	153071	63330121
Interleukin level increased	29.34	27.78	7	5823	420	63482772
Death	28.40	27.78	87	5743	374294	63108898
Haemolytic transfusion reaction	28.17	27.78	4	5826	10	63483182
Disseminated intravascular coagulation	28.09	27.78	19	5811	19032	63464160

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	858.62	24.40	281	7429	22596	34926625
Acute lymphocytic leukaemia recurrent	818.00	24.40	178	7532	2866	34946355
Neurotoxicity	389.14	24.40	147	7563	17863	34931358
Pyrexia	358.49	24.40	400	7310	332613	34616608
Central nervous system leukaemia	199	24.40	37	7673	249	34948972
Blast cell count increased	191.31	24.40	45	7665	1033	34948188
Leukaemic infiltration extramedullary	185.08	24.40	30	7680	75	34949146
Acute lymphocytic leukaemia refractory	105.23	24.40	19	7691	106	34949115
Minimal residual disease	103.05	24.40	23	7687	414	34948807
Acute lymphocytic leukaemia	81.07	24.40	29	7681	3000	34946221
Aphasia	77.52	24.40	52	7658	21402	34927819
Tremor	77.20	24.40	93	7617	82494	34866727
Product preparation error	72.81	24.40	25	7685	2292	34946929
Nervous system disorder	69.34	24.40	42	7668	14501	34934720
Therapy non-responder	65.12	24.40	60	7650	39086	34910135
Cytopenia	58.74	24.40	36	7674	12687	34936534
Device related infection	55.68	24.40	39	7671	17198	34932023
Aspiration bone marrow abnormal	53.67	24.40	11	7699	129	34949092
Graft versus host disease	49.03	24.40	30	7680	10539	34938682
Encephalopathy	49.01	24.40	49	7661	35270	34913951
Febrile neutropenia	46.72	24.40	97	7613	136752	34812469
Accidental exposure to product	46.15	24.40	31	7679	12771	34936450
Blast cells present	44.32	24.40	12	7698	491	34948730
Metastases to muscle	42.27	24.40	10	7700	235	34948986
Metastases to retroperitoneum	41.83	24.40	10	7700	246	34948975
Hepatotoxicity	41.80	24.40	36	7674	21449	34927772
Graft versus host disease in gastrointestinal tract	41.73	24.40	19	7691	3664	34945557
Metastases to bone marrow	38.95	24.40	11	7699	527	34948694
Personality change due to a general medical condition	38.33	24.40	7	7703	42	34949179
Graft versus host disease in skin	37.51	24.40	18	7692	3907	34945314
Neurological symptom	36.41	24.40	18	7692	4167	34945054
Infusion site haemorrhage	36.14	24.40	12	7698	992	34948229
Metastases to spleen	35.82	24.40	10	7700	459	34948762
Confusional state	34.62	24.40	89	7621	144071	34805150
Venoocclusive disease	33.14	24.40	15	7695	2852	34946369
Chronic graft versus host disease	32.76	24.40	17	7693	4356	34944865
Off label use	32.14	24.40	179	7531	419345	34529876
Systemic mycosis	30.88	24.40	12	7698	1561	34947660
Tumour lysis syndrome	30.01	24.40	27	7683	17032	34932189
Incorrect drug administration rate	29.94	24.40	12	7698	1693	34947528
Hyperphosphataemia	29.70	24.40	16	7694	4421	34944800
Fall	28.89	24.40	5	7705	202880	34746341
Vascular device occlusion	28.18	24.40	7	7703	203	34949018
Venoocclusive liver disease	28.01	24.40	19	7691	7947	34941274
Leukoencephalopathy	27.66	24.40	15	7695	4200	34945021
Pancytopenia	27.35	24.40	63	7647	95094	34854127
Diarrhoea	26.80	24.40	28	7682	389884	34559337
CSF cell count increased	25.91	24.40	5	7705	42	34949179
Apraxia	25.39	24.40	10	7700	1348	34947873
Serum ferritin increased	24.86	24.40	16	7694	6130	34943091
Mental status changes	24.84	24.40	36	7674	38047	34911174
Acute graft versus host disease in skin	24.72	24.40	15	7695	5186	34944035
Hepatic calcification	24.69	24.40	7	7703	340	34948881

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	1553.43	23.24	307	11972	4417	79727692
Cytokine release syndrome	1410.27	23.24	420	11859	35578	79696531
Neurotoxicity	645.83	23.24	227	12052	32291	79699818
Pyrexia	538.46	23.24	586	11693	678123	79053986
Central nervous system leukaemia	315.43	23.24	55	12224	371	79731738
Leukaemic infiltration extramedullary	276.86	23.24	44	12235	151	79731958
Blast cell count increased	222.29	23.24	50	12229	1360	79730749
Acute lymphocytic leukaemia refractory	160.40	23.24	27	12252	143	79731966
Acute lymphocytic leukaemia	151.52	23.24	48	12231	4921	79727188
Febrile neutropenia	138.59	23.24	174	12105	230825	79501284
Graft versus host disease in skin	122.62	23.24	43	12236	6030	79726079
Aphasia	115.29	23.24	78	12201	46654	79685455
Tremor	113.06	23.24	135	12144	169948	79562161
Nervous system disorder	112.86	23.24	63	12216	26793	79705316
Graft versus host disease	112.26	23.24	52	12227	14974	79717135
Therapy non-responder	98.05	23.24	94	12185	92211	79639898
Graft versus host disease in gastrointestinal tract	91.22	23.24	35	12244	6321	79725788
Minimal residual disease	91.01	23.24	20	12259	487	79731622
Venoocclusive disease	90.87	23.24	32	12247	4541	79727568
Device related infection	83.99	23.24	57	12222	34237	79697872
Philadelphia chromosome positive	79.66	23.24	19	12260	671	79731438
Intercepted product preparation error	78.80	23.24	27	12252	3533	79728576
Neoplasm recurrence	78.09	23.24	28	12251	4186	79727923
Tumour lysis syndrome	73.87	23.24	46	12233	23893	79708216
Venoocclusive liver disease	73.46	23.24	36	12243	11735	79720374
Product preparation error	72.89	23.24	29	12250	5764	79726345
Cytopenia	70.14	23.24	42	12237	20341	79711768
Infusion site haemorrhage	70.00	23.24	25	12254	3695	79728414
Leukoencephalopathy	64.12	23.24	29	12250	7900	79724209
Encephalopathy	62.93	23.24	64	12215	67333	79664776
Babesiosis	57.90	23.24	13	12266	350	79731759
Seizure	57.85	23.24	104	12175	188730	79543379
CSF cell count increased	57.85	23.24	11	12268	126	79731983
Leukaemia recurrent	57.37	23.24	20	12259	2754	79729355
Acute graft versus host disease in skin	55.63	23.24	26	12253	7632	79724477
Neutropenia	54.55	23.24	130	12149	287580	79444529
Acute graft versus host disease	51.48	23.24	27	12252	10140	79721969
Blast cells present	50.20	23.24	14	12265	923	79731186
Hepatotoxicity	50.19	23.24	50	12229	51302	79680807
Escherichia bacteraemia	49.91	23.24	23	12256	6539	79725570
Pancytopenia	47.86	23.24	89	12190	165656	79566453
Therapeutic response delayed	47.47	23.24	14	12265	1128	79730981
Leukaemic infiltration renal	45.01	23.24	7	12272	20	79732089
Chronic graft versus host disease	43.09	23.24	21	12258	6760	79725349
Off label use	42.45	23.24	261	12018	906954	78825155
Metastases to muscle	42.01	23.24	10	12269	350	79731759
Disseminated intravascular coagulation	40.88	23.24	38	12241	35804	79696305
Metastases to retroperitoneum	40.87	23.24	10	12269	394	79731715
Transformation to acute myeloid leukaemia	40.47	23.24	12	12267	985	79731124
Neutrophil count decreased	39.90	23.24	60	12219	93899	79638210
Apraxia	38.34	23.24	15	12264	2852	79729257
Metastases to bone marrow	38.25	23.24	11	12268	811	79731298
Jaw operation	38.15	23.24	11	12268	818	79731291
Fall	37.72	23.24	14	12265	487615	79244494
Accidental exposure to product	37.26	23.24	34	12245	31288	79700821
Dyspnoea	36.74	23.24	47	12232	856978	78875131
Metastases to spleen	36.24	23.24	10	12269	634	79731475
Drug hypersensitivity	34.91	23.24	3	12276	298913	79433196
Bone marrow failure	34.59	23.24	41	12238	51066	79681043
Pain	34.03	23.24	35	12244	703767	79028342
Dysgraphia	33.40	23.24	15	12264	4017	79728092
Fusarium infection	33.29	23.24	12	12267	1820	79730289
Blood lactate dehydrogenase increased	32.61	23.24	35	12244	39135	79692974
Neurological symptom	32.57	23.24	19	12260	8764	79723345
Systemic mycosis	32.34	23.24	13	12266	2653	79729456
Diarrhoea	32.14	23.24	54	12225	880435	78851674
Aspiration bone marrow abnormal	32.03	23.24	7	12272	166	79731943
Platelet count decreased	31.63	23.24	83	12196	194581	79537528
Pruritus	31.07	23.24	11	12268	394637	79337472
Joint swelling	30.88	23.24	4	12275	288642	79443467
Blood bilirubin increased	30.57	23.24	44	12235	66188	79665921
Serum ferritin increased	30.57	23.24	19	12260	9828	79722281
Precursor B-lymphoblastic lymphoma recurrent	30.47	23.24	5	12274	22	79732087
Cytomegalovirus infection	30.17	23.24	35	12244	42609	79689500
Personality change due to a general medical condition	29.69	23.24	7	12272	235	79731874
Disease progression	29.33	23.24	78	12201	184284	79547825
Condition aggravated	28.96	23.24	21	12258	501103	79231006
Fatigue	27.89	23.24	64	12215	929663	78802446
Thrombocytopenia	27.87	23.24	97	12182	265162	79466947
Interleukin level increased	27.81	23.24	8	12271	590	79731519
Trichosporon infection	27.70	23.24	9	12270	999	79731110
Capillary leak syndrome	27.50	23.24	13	12266	3912	79728197
Transplantation complication	27.37	23.24	7	12272	331	79731778
Hyperphosphataemia	26.89	23.24	15	12264	6361	79725748
Hepatic calcification	26.70	23.24	7	12272	365	79731744
White blood cell count increased	26.61	23.24	44	12235	74589	79657520
Confusional state	26.54	23.24	108	12171	317889	79414220
Neoplasm progression	26.33	23.24	36	12243	51646	79680463
Transaminases increased	26.29	23.24	36	12243	51707	79680402
Alanine aminotransferase increased	26.07	23.24	69	12210	162501	79569608
Adrenomegaly	26.01	23.24	7	12272	404	79731705
Lymphocyte count decreased	25.71	23.24	34	12245	47255	79684854
Ataxia	25.61	23.24	25	12254	25014	79707095
Lineage switch leukaemia	25.57	23.24	4	12275	12	79732097
Nausea	25.51	23.24	70	12209	957126	78774983
Haemolytic transfusion reaction	25.33	23.24	4	12275	13	79732096
Procalcitonin increased	24.32	23.24	11	12268	2995	79729114
Hypoproteinaemia	24.13	23.24	12	12267	4034	79728075
Drug resistance	23.95	23.24	31	12248	42182	79689927
Costal cartilage fracture	23.90	23.24	6	12273	263	79731846
Chronic graft versus host disease in skin	23.78	23.24	9	12270	1565	79730544
Hypogammaglobulinaemia	23.61	23.24	18	12261	12933	79719176

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