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

Stem definition	Drug id	CAS RN
antineoplastics, thiotepa derivatives	2638	52-24-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: thio-tepa triethylenethiophosphortriamide thiotepa oncotepa phosphorothioic acid triethylenetriamide tespamin tespamine thiophosphamide tepadina	A very toxic alkylating antineoplastic agent also used as an insect sterilant. It causes skin, gastrointestinal, CNS, and bone marrow damage. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), thiotepa may reasonably be anticipated to be a carcinogen (Merck Index, 11th ed). Molecular weight: 189.22 Formula: C6H12N3PS CLOGP: 0.52 LIPINSKI: 0 HAC: 3 HDO: 0 TPSA: 9.03 ALOGS: -1.31 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

thio-tepa
triethylenethiophosphortriamide
thiotepa
oncotepa
phosphorothioic acid triethylenetriamide
tespamin
tespamine
thiophosphamide
tepadina

A very toxic alkylating antineoplastic agent also used as an insect sterilant. It causes skin, gastrointestinal, CNS, and bone marrow damage. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), thiotepa may reasonably be anticipated to be a carcinogen (Merck Index, 11th ed).

Molecular weight: 189.22
Formula: C6H12N3PS
CLOGP: 0.52
LIPINSKI: 0
HAC: 3
HDO: 0
TPSA: 9.03
ALOGS: -1.31
ROTB: 3

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution)	1.60 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	6.70 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.90 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	2.70 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	100 mg/mL	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company
March 26, 2019	PMDA	Sumitomo Dainippon Pharma
March 26, 2021	EMA	RIEMSER Pharma GmbH
March 9, 1959	FDA

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
Mucosal inflammation	520.43	40.26	192	6418	46736	63435676
Human herpesvirus 6 infection	456.28	40.26	96	6514	2861	63479551
Acute graft versus host disease	439.17	40.26	100	6510	4328	63478084
Cytomegalovirus infection	340.15	40.26	114	6496	20838	63461574
Acute graft versus host disease in skin	263.14	40.26	63	6547	3389	63479023
Cytomegalovirus infection reactivation	254.50	40.26	63	6547	3900	63478512
Graft versus host disease in skin	242.16	40.26	57	6553	2848	63479564
Venoocclusive liver disease	237.23	40.26	62	6548	4773	63477639
Chronic graft versus host disease	233.27	40.26	56	6554	3046	63479366
Febrile neutropenia	228.52	40.26	146	6464	118303	63364109
Thrombotic microangiopathy	209.79	40.26	67	6543	10494	63471918
Graft versus host disease	207.68	40.26	60	6550	6703	63475709
Haematotoxicity	196.64	40.26	62	6548	9314	63473098
Encephalitis viral	192.71	40.26	43	6567	1689	63480723
Product use in unapproved indication	186.95	40.26	152	6458	178928	63303484
Adenovirus infection	176.16	40.26	46	6564	3525	63478887
Pre-engraftment immune reaction	175.98	40.26	29	6581	209	63482203
Cytomegalovirus viraemia	155.28	40.26	46	6564	5603	63476809
Graft versus host disease in gastrointestinal tract	146.70	40.26	39	6571	3202	63479210
Acute graft versus host disease in intestine	118.29	40.26	29	6581	1720	63480692
Thrombocytopenia	114.47	40.26	107	6503	151050	63331362
Bacterial sepsis	112.13	40.26	33	6577	3925	63478487
Neutropenia	112.11	40.26	113	6497	174892	63307520
Epstein-Barr virus infection	104.08	40.26	37	6573	8013	63474399
Venoocclusive disease	103.85	40.26	27	6583	2031	63480381
Acute lymphocytic leukaemia recurrent	101.24	40.26	27	6583	2242	63480170
Posterior reversible encephalopathy syndrome	98.44	40.26	44	6566	17301	63465111
BK virus infection	95.79	40.26	28	6582	3251	63479161
Transplant dysfunction	92.97	40.26	30	6580	4842	63477570
Viraemia	84.85	40.26	21	6589	1295	63481117
Viral haemorrhagic cystitis	77.39	40.26	18	6592	851	63481561
Transplant failure	76.14	40.26	20	6590	1565	63480847
Sepsis	75.26	40.26	86	6524	153037	63329375
Cystitis haemorrhagic	73.04	40.26	24	6586	4099	63478313
Neurotoxicity	68.35	40.26	34	6576	16956	63465456
Off label use	67.43	40.26	187	6423	674275	62808137
Gastroenteritis adenovirus	67.36	40.26	13	6597	246	63482166
Skin toxicity	66.02	40.26	23	6587	4691	63477721
Bacteraemia	64.76	40.26	33	6577	17315	63465097
Cytomegalovirus chorioretinitis	64.45	40.26	18	6592	1775	63480637
Chronic graft versus host disease in skin	63.91	40.26	15	6595	738	63481674
Fatigue	63.02	40.26	9	6601	888019	62594393
Neoplasm recurrence	61.80	40.26	19	6591	2619	63479793
Toxic erythema of chemotherapy	61.53	40.26	11	6599	134	63482278
Meningoencephalitis herpetic	61.47	40.26	16	6594	1208	63481204
Leukoencephalopathy	59.76	40.26	21	6589	4392	63478020
Multiple organ dysfunction syndrome	58.59	40.26	48	6562	56704	63425708
Hypogonadism female	57.28	40.26	8	6602	14	63482398
Cytomegalovirus urinary tract infection	54.96	40.26	9	6601	62	63482350
Post transplant lymphoproliferative disorder	53.40	40.26	20	6590	5011	63477401
Progressive multifocal leukoencephalopathy	52.30	40.26	26	6584	12945	63469467
Pulmonary arterial hypertension	51.37	40.26	31	6579	22546	63459866
Pyrexia	50.39	40.26	134	6476	470344	63012068
Dyspnoea	48.51	40.26	6	6604	661307	62821105
Engraftment syndrome	47.77	40.26	11	6599	497	63481915
Stem cell transplant	46.42	40.26	14	6596	1808	63480604
Leukaemia recurrent	46.12	40.26	13	6597	1325	63481087
Pain	45.02	40.26	11	6599	740617	62741795
Pulmonary vascular disorder	44.79	40.26	10	6600	393	63482019
Alveolar soft part sarcoma	44.63	40.26	8	6602	99	63482313
Osteosarcoma	42.54	40.26	8	6602	131	63482281
Arthralgia	42.17	40.26	5	6605	569705	62912707
Lower respiratory tract infection fungal	40.91	40.26	9	6601	330	63482082
JC virus infection	40.64	40.26	13	6597	2038	63480374

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
Mucosal inflammation	531.94	34.26	231	7870	38391	34910439
Cytomegalovirus infection	452.16	34.26	184	7917	25951	34922879
Acute graft versus host disease in skin	379.42	34.26	108	7993	5093	34943737
Acute graft versus host disease	342.77	34.26	105	7996	6398	34942432
Venoocclusive liver disease	305.66	34.26	101	8000	7865	34940965
Acute graft versus host disease in intestine	294.34	34.26	77	8024	2631	34946199
Human herpesvirus 6 infection	274.25	34.26	69	8032	2012	34946818
Adenovirus infection	269.01	34.26	83	8018	5174	34943656
Graft versus host disease in skin	261.60	34.26	76	8025	3849	34944981
Graft versus host disease in gastrointestinal tract	226.45	34.26	67	8034	3616	34945214
Haematotoxicity	188.31	34.26	71	8030	8123	34940707
Cytomegalovirus infection reactivation	169.00	34.26	58	8043	5060	34943770
Epstein-Barr virus infection	160.55	34.26	62	8039	7566	34941264
Febrile neutropenia	158.63	34.26	176	7925	136673	34812157
Chronic graft versus host disease	153.95	34.26	52	8049	4321	34944509
Engraftment syndrome	151.13	34.26	37	8064	960	34947870
Graft versus host disease	131.37	34.26	59	8042	10510	34938320
Venoocclusive disease	128.79	34.26	41	8060	2826	34946004
Product use in unapproved indication	127.29	34.26	146	7955	117353	34831477
Viral haemorrhagic cystitis	125.51	34.26	33	8068	1147	34947683
Thrombotic microangiopathy	109.20	34.26	52	8049	10578	34938252
Cytomegalovirus viraemia	103.69	34.26	45	8056	7385	34941445
BK virus infection	97.58	34.26	40	8061	5698	34943132
Graft versus host disease in liver	95.06	34.26	27	8074	1257	34947573
Cystitis haemorrhagic	94.57	34.26	39	8062	5640	34943190
Posterior reversible encephalopathy syndrome	94.09	34.26	46	8055	9908	34938922
Pulmonary vascular disorder	91.34	34.26	23	8078	671	34948159
Pulmonary arterial hypertension	87.47	34.26	42	8059	8697	34940133
Chronic graft versus host disease in skin	83.61	34.26	23	8078	951	34947879
Post transplant lymphoproliferative disorder	82.88	34.26	37	8064	6491	34942339
Off label use	80.99	34.26	246	7855	419278	34529552
Encephalitis viral	78.64	34.26	23	8078	1189	34947641
Pulmonary arteriopathy	70.83	34.26	13	8088	76	34948754
Parainfluenzae virus infection	70.37	34.26	26	8075	2804	34946026
Autoimmune lymphoproliferative syndrome	68.61	34.26	14	8087	152	34948678
Multiple organ dysfunction syndrome	67.77	34.26	86	8015	76480	34872350
Thrombocytopenia	64.09	34.26	123	7978	156124	34792706
Osteosarcoma	60.68	34.26	14	8087	279	34948551
Acute graft versus host disease in liver	60.57	34.26	20	8081	1546	34947284
Fatigue	59.28	34.26	8	8093	370645	34578185
Juvenile melanoma benign	59.00	34.26	11	8090	71	34948759
Pre-engraftment immune reaction	56.93	34.26	11	8090	88	34948742
Dyspnoea	53.89	34.26	11	8090	376771	34572059
Epstein-Barr viraemia	51.73	34.26	17	8084	1295	34947535
Cytomegalovirus chorioretinitis	50.92	34.26	22	8079	3567	34945263
Bacterial sepsis	48.82	34.26	24	8077	5226	34943604
Pneumonia cytomegaloviral	47.56	34.26	20	8081	3034	34945796
Idiopathic pneumonia syndrome	45.93	34.26	11	8090	259	34948571
Myelitis transverse	45.87	34.26	15	8086	1125	34947705
Sepsis	45.17	34.26	111	7990	166450	34782380
Bronchiolitis obliterans syndrome	43.50	34.26	10	8091	196	34948634
Autoimmune haemolytic anaemia	43.14	34.26	21	8080	4475	34944355
NPM1 gene mutation	42.61	34.26	9	8092	117	34948713
Neutropenia	40.94	34.26	103	7998	156675	34792155
Death	40.48	34.26	21	8080	398028	34550802
CNS ventriculitis	40.17	34.26	10	8091	278	34948552
Chronic graft versus host disease in liver	40.14	34.26	11	8090	448	34948382
Aplasia	39.77	34.26	20	8081	4568	34944262
Gastrointestinal toxicity	39.66	34.26	17	8084	2702	34946128
Respiratory syncytial virus infection	39.28	34.26	20	8081	4689	34944141
Clostridium difficile colitis	39.05	34.26	31	8070	15699	34933131
Retinopathy haemorrhagic	38.27	34.26	7	8094	40	34948790
Bone marrow failure	37.85	34.26	40	8061	29213	34919617
Asthenia	37.51	34.26	6	8095	245245	34703585
Multisystem inflammatory syndrome in children	37.31	34.26	6	8095	13	34948817
Encephalitis cytomegalovirus	36.91	34.26	11	8090	607	34948223
Chimerism	36.73	34.26	9	8092	234	34948596
Hyperfibrinogenaemia	36.12	34.26	7	8094	57	34948773
Chronic graft versus host disease in intestine	36.02	34.26	9	8092	254	34948576
Leukoencephalopathy	35.44	34.26	18	8083	4197	34944633
Bone sarcoma	34.92	34.26	7	8094	69	34948761

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
Mucosal inflammation	856.60	32.20	365	13869	75215	79654939
Cytomegalovirus infection	849.98	32.20	310	13924	42334	79687820
Acute graft versus host disease in skin	730.42	32.20	186	14048	7472	79722682
Human herpesvirus 6 infection	681.22	32.20	164	14070	5206	79724948
Acute graft versus host disease	632.00	32.20	176	14058	9991	79720163
Adenovirus infection	523.90	32.20	146	14088	8301	79721853
Venoocclusive liver disease	523.21	32.20	157	14077	11614	79718540
Graft versus host disease in skin	470.08	32.20	125	14109	5948	79724206
Acute graft versus host disease in intestine	449.17	32.20	111	14123	3930	79726224
Cytomegalovirus infection reactivation	412.24	32.20	122	14112	8594	79721560
Haematotoxicity	381.40	32.20	132	14102	15387	79714767
Febrile neutropenia	379.70	32.20	320	13914	230679	79499475
Graft versus host disease	339.28	32.20	120	14114	14906	79715248
Graft versus host disease in gastrointestinal tract	331.51	32.20	96	14138	6260	79723894
Product use in unapproved indication	324.01	32.20	303	13931	250056	79480098
Epstein-Barr virus infection	294.82	32.20	107	14127	14309	79715845
Chronic graft versus host disease	286.39	32.20	87	14147	6694	79723460
Thrombotic microangiopathy	277.02	32.20	112	14122	20057	79710097
Encephalitis viral	262.33	32.20	66	14168	2513	79727641
Venoocclusive disease	256.02	32.20	73	14161	4500	79725654
Cytomegalovirus viraemia	250.41	32.20	92	14142	12729	79717425
Pre-engraftment immune reaction	219.64	32.20	40	14194	301	79729853
Viral haemorrhagic cystitis	210.89	32.20	53	14181	2008	79728146
BK virus infection	205.12	32.20	72	14162	8732	79721422
Engraftment syndrome	183.56	32.20	44	14190	1365	79728789
Bacterial sepsis	164.40	32.20	60	14174	8138	79722016
Cystitis haemorrhagic	161.45	32.20	61	14173	9111	79721043
Posterior reversible encephalopathy syndrome	146.14	32.20	78	14156	26203	79703951
Chronic graft versus host disease in skin	139.04	32.20	36	14198	1538	79728616
Pulmonary vascular disorder	137.46	32.20	33	14201	1030	79729124
Off label use	133.12	32.20	408	13826	906807	78823347
Post transplant lymphoproliferative disorder	131.47	32.20	56	14178	11408	79718746
Pulmonary arterial hypertension	124.36	32.20	72	14162	28294	79701860
Fatigue	123.27	32.20	12	14222	929715	78800439
Thrombocytopenia	122.07	32.20	190	14044	265069	79465085
Multiple organ dysfunction syndrome	120.64	32.20	127	14107	120119	79610035
Autoimmune haemolytic anaemia	120.06	32.20	48	14186	8332	79721822
Sepsis	114.36	32.20	186	14048	269242	79460912
Neutropenia	104.08	32.20	185	14049	287525	79442629
Dyspnoea	103.82	32.20	15	14219	857010	78873144
Acute lymphocytic leukaemia recurrent	100.03	32.20	36	14198	4688	79725466
Osteosarcoma	99.09	32.20	21	14213	367	79729787
Acute graft versus host disease in liver	95.44	32.20	28	14206	1907	79728247
Transplant dysfunction	95.32	32.20	39	14195	7182	79722972
Pulmonary arteriopathy	91.13	32.20	16	14218	95	79730059
Cytomegalovirus chorioretinitis	84.07	32.20	33	14201	5457	79724697
Epstein-Barr viraemia	83.37	32.20	26	14208	2179	79727975
Gastroenteritis adenovirus	82.49	32.20	18	14216	363	79729791
Arthralgia	82.32	32.20	5	14229	571798	79158356
Leukoencephalopathy	81.96	32.20	36	14198	7893	79722261
Viraemia	80.59	32.20	27	14207	2842	79727312
Transplant failure	78.54	32.20	30	14204	4611	79725543
Toxic erythema of chemotherapy	77.85	32.20	16	14218	239	79729915
Skin toxicity	77.15	32.20	35	14199	8279	79721875
Graft versus host disease in liver	76.16	32.20	23	14211	1731	79728423
Respiratory syncytial virus infection	76.09	32.20	36	14198	9366	79720788
Dizziness	71.73	32.20	6	14228	526435	79203719
Pain	71.14	32.20	19	14215	703783	79026371
Autoimmune lymphoproliferative syndrome	70.44	32.20	14	14220	175	79729979
Parainfluenzae virus infection	69.28	32.20	29	14205	5653	79724501
Pyrexia	68.32	32.20	270	13964	678439	79051715
Neoplasm recurrence	66.89	32.20	26	14208	4188	79725966
Gastrointestinal toxicity	65.47	32.20	31	14203	8078	79722076
Bacteraemia	65.29	32.20	51	14183	32773	79697381
Pneumonia cytomegaloviral	62.74	32.20	26	14208	4943	79725211
Neurotoxicity	61.40	32.20	49	14185	32469	79697685
Focal nodular hyperplasia	60.85	32.20	16	14218	726	79729428
Metaplasia	60.22	32.20	15	14219	547	79729607
Stem cell transplant	59.31	32.20	23	14211	3681	79726473
Leukaemia recurrent	58.21	32.20	21	14213	2753	79727401
Myelitis transverse	57.39	32.20	19	14215	1928	79728226
Bone marrow failure	56.65	32.20	57	14177	51050	79679104
Pruritus	55.12	32.20	4	14230	394644	79335510
Idiopathic pneumonia syndrome	54.43	32.20	14	14220	582	79729572
Meningoencephalitis herpetic	53.03	32.20	18	14216	1971	79728183
Hypogonadism female	52.96	32.20	8	14226	14	79730140
Aplasia	51.46	32.20	26	14208	7794	79722360
Hepatotoxicity	51.00	32.20	54	14180	51298	79678856
Chronic graft versus host disease in intestine	50.66	32.20	12	14222	353	79729801
NPM1 gene mutation	49.95	32.20	10	14224	130	79730024
Clostridium difficile colitis	49.24	32.20	43	14191	32240	79697914
Malaise	47.98	32.20	14	14220	489855	79240299
Cytomegalovirus urinary tract infection	47.49	32.20	9	14225	86	79730068
Bone sarcoma	46.94	32.20	9	14225	92	79730062
Pericardial effusion	46.59	32.20	49	14185	46188	79683966
Multisystem inflammatory syndrome in children	46.40	32.20	8	14226	42	79730112
Bronchiolitis obliterans syndrome	46.30	32.20	11	14223	328	79729826
Headache	46.21	32.20	30	14204	653742	79076412
Rhinovirus infection	45.30	32.20	24	14210	7929	79722225
Disseminated toxoplasmosis	44.83	32.20	10	14224	224	79729930
Mucosal toxicity	44.74	32.20	12	14222	588	79729566
Asthenia	44.29	32.20	18	14216	511671	79218483
Toxoplasmosis	44.08	32.20	17	14217	2680	79727474
Chronic graft versus host disease in liver	43.48	32.20	12	14222	655	79729499
Chimerism	42.49	32.20	10	14224	286	79729868
Nausea	42.47	32.20	66	14168	957130	78773024
Encephalitis cytomegalovirus	41.14	32.20	13	14221	1137	79729017
Aplastic anaemia	40.40	32.20	30	14204	17875	79712279
Pulmonary veno-occlusive disease	40.38	32.20	14	14220	1634	79728520
Condition aggravated	39.66	32.20	20	14214	501104	79229050
Second primary malignancy	39.18	32.20	27	14207	14323	79715831
Pain in extremity	38.38	32.20	9	14225	364529	79365625
Cardiotoxicity	38.14	32.20	25	14209	12214	79717940
Acute respiratory distress syndrome	37.95	32.20	43	14191	44024	79686130
Weight decreased	36.94	32.20	9	14225	355189	79374965
Retinopathy haemorrhagic	36.56	32.20	7	14227	71	79730083
Constipation	36.46	32.20	4	14230	283046	79447108
Herpes simplex	35.81	32.20	24	14210	12163	79717991
Pancytopenia	35.47	32.20	86	14148	165659	79564495
Myelopathy	35.23	32.20	17	14217	4616	79725538
Back pain	35.16	32.20	6	14228	304174	79425980
Premature menopause	35.12	32.20	10	14224	612	79729542
Bacille Calmette-Guerin scar reactivation	35.04	32.20	6	14228	30	79730124
Alveolar soft part sarcoma	34.82	32.20	7	14227	93	79730061
Parvovirus B19 infection	34.06	32.20	12	14222	1468	79728686
Hyperfibrinogenaemia	34.03	32.20	7	14227	105	79730049
Myelodysplastic syndrome	33.94	32.20	34	14200	30267	79699887
Acute myeloid leukaemia recurrent	33.80	32.20	15	14219	3368	79726786
Abdominal discomfort	33.71	32.20	3	14231	250724	79479430
Herpes simplex reactivation	33.00	32.20	9	14225	470	79729684
Disease recurrence	32.93	32.20	40	14194	44069	79686085

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01AC01	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS ALKYLATING AGENTS Ethylene imines
FDA MoA	N0000000236	Alkylating Activity
FDA EPC	N0000175558	Alkylating Drug
MeSH PA	D000477	Alkylating Agents
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D018906	Antineoplastic Agents, Alkylating
MeSH PA	D007155	Immunologic Factors
MeSH PA	D007166	Immunosuppressive Agents
MeSH PA	D019653	Myeloablative Agonists
MeSH PA	D009676	Noxae

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

Disease	Relation	SNOMED_ID	DOID
Allogeneic bone marrow transplantation	indication	58390007
Hodgkin's disease	indication	118599009
Malignant lymphoma	indication	118600007	DOID:0060058
Non-Hodgkin's lymphoma	indication	118601006
Malignant tumor of ovary	indication	363443007	DOID:2394
Malignant tumor of urinary bladder	indication	399326009	DOID:11054
Carcinoma of female breast	indication	447782002
Pleural Malignant Effusions	indication
Peritoneal Malignant Effusions	indication
Pericardial Malignant Effusions	indication
Acute infectious disease	contraindication	63171007
Blood coagulation disorder	contraindication	64779008	DOID:1247
Leukopenia	contraindication	84828003	DOID:615
Kidney disease	contraindication	90708001	DOID:557
Disease of liver	contraindication	235856003	DOID:409
Anemia	contraindication	271737000	DOID:2355
Pregnancy, function	contraindication	289908002
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Bone marrow depression	contraindication	307762000
Breastfeeding (mother)	contraindication	413712001

🐶 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)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG/VIAL	TEPADINA	ADIENNE SA	N208264	Jan. 26, 2017	RX	POWDER	INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Jan. 26, 2024	INDICATED FOR REDUCING THE RISK OF GRAFT REJECTION WHEN USED IN CONJUNCTION WITH HIGH-DOSE BUSULFAN & CYCLOPHOSPHAMIDE AS A PREPARATIVE REGIMEN FOR ALLOGENIC HEMATOPOIETIC PROGENITOR CELL TRANSPLANTATION FOR PEDS. PATIENTS WITH CLASS 3 BETA-THALASSEMIA
15MG/VIAL	TEPADINA	ADIENNE SA	N208264	Jan. 26, 2017	RX	POWDER	INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	Jan. 26, 2024	INDICATED FOR REDUCING THE RISK OF GRAFT REJECTION WHEN USED IN CONJUNCTION WITH HIGH-DOSE BUSULFAN & CYCLOPHOSPHAMIDE AS A PREPARATIVE REGIMEN FOR ALLOGENIC HEMATOPOIETIC PROGENITOR CELL TRANSPLANTATION FOR PEDS. PATIENTS WITH CLASS 3 BETA-THALASSEMIA

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Cytochrome P450 2B6	Enzyme	P20813	CP2B6_HUMAN	INHIBITOR	Ki	5.32		IUPHAR

External reference:

ID	Source
4017910	VUID
N0000146261	NUI
D00583	KEGG_DRUG
4017910	VANDF
C0039871	UMLSCUI
CHEBI:9570	CHEBI
CHEMBL671	ChEMBL_ID
D013852	MESH_DESCRIPTOR_UI
DB04572	DRUGBANK_ID
7622	IUPHAR_LIGAND_ID
881	INN_ID
905Z5W3GKH	UNII
5453	PUBCHEM_CID
10473	RXNORM
184712	MMSL
2134	MMSL
5573	MMSL
d00390	MMSL
002637	NDDF
387508004	SNOMEDCT_US
88997008	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Thiotepa	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9309	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	15 mg	INTRACAVITARY	ANDA	22 sections
Thiotepa	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9309	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	15 mg	INTRACAVITARY	ANDA	22 sections
Thiotepa	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9565	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	15 mg	INTRACAVITARY	ANDA	22 sections
Thiotepa	HUMAN PRESCRIPTION DRUG LABEL	1	25021-246	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	15 mg	INTRAVENOUS	ANDA	23 sections
Thiotepa	HUMAN PRESCRIPTION DRUG LABEL	1	43598-171	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVESICAL	ANDA	27 sections
Thiotepa	HUMAN PRESCRIPTION DRUG LABEL	1	43598-650	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	15 mg	INTRAVENOUS	ANDA	20 sections
Thiotepa	HUMAN PRESCRIPTION DRUG LABEL	1	54879-014	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	15 mg	INTRACAVITARY	ANDA	23 sections
Thiotepa	HUMAN PRESCRIPTION DRUG LABEL	1	54879-014	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	15 mg	INTRACAVITARY	ANDA	23 sections
Thiotepa	HUMAN PRESCRIPTION DRUG LABEL	1	65219-029	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	27 sections
Thiotepa	Human Prescription Drug Label	1	68083-446	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	15 mg	INTRAVENOUS	ANDA	27 sections
Thiotepa	Human Prescription Drug Label	1	68083-503	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	27 sections
Thiotepa	Human Prescription Drug Label	1	69539-123	INJECTION, POWDER, FOR SOLUTION	15 mg	INTRAVENOUS	ANDA	25 sections
Thiotepa	Human Prescription Drug Label	1	69539-124	INJECTION, POWDER, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	25 sections
TEPADINA	HUMAN PRESCRIPTION DRUG LABEL	1	70121-1630	INJECTION, POWDER, FOR SOLUTION	15 mg	INTRACAVITARY	NDA	18 sections
TEPADINA	HUMAN PRESCRIPTION DRUG LABEL	1	70121-1630	INJECTION, POWDER, FOR SOLUTION	15 mg	INTRACAVITARY	NDA	18 sections
TEPADINA	HUMAN PRESCRIPTION DRUG LABEL	1	70121-1630	INJECTION, POWDER, FOR SOLUTION	15 mg	INTRACAVITARY	NDA	18 sections
TEPADINA	HUMAN PRESCRIPTION DRUG LABEL	1	70121-1631	INJECTION, POWDER, FOR SOLUTION	100 mg	INTRACAVITARY	NDA	18 sections
TEPADINA	HUMAN PRESCRIPTION DRUG LABEL	1	70121-1631	INJECTION, POWDER, FOR SOLUTION	100 mg	INTRACAVITARY	NDA	18 sections
TEPADINA	HUMAN PRESCRIPTION DRUG LABEL	1	70121-1631	INJECTION, POWDER, FOR SOLUTION	100 mg	INTRACAVITARY	NDA	18 sections
Thiotepa	HUMAN PRESCRIPTION DRUG LABEL	1	70860-220	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	15 mg	INTRAVENOUS	ANDA	23 sections
Thiotepa	Human Prescription Drug Label	1	72205-045	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	15 mg	INTRAVENOUS	ANDA	25 sections
Thiotepa	Human Prescription Drug Label	1	72205-046	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	25 sections