bendamustine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antineoplastic, alkylating agents, (beta-chloroethyl)amine derivatives	302	16506-27-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: bendamustine bendamustine hydrochloride treanda bendamustine HCl	A nitrogen mustard compound that functions as an ALKYLATING ANTINEOPLASTIC AGENT and is used in the treatment of CHRONIC LYMPHOCYTIC LEUKEMIA and NON-HODGKIN'S LYMPHOMA. Molecular weight: 358.26 Formula: C16H21Cl2N3O2 CLOGP: 3.24 LIPINSKI: 0 HAC: 5 HDO: 1 TPSA: 58.36 ALOGS: -3.76 ROTB: 9 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

bendamustine
bendamustine hydrochloride
treanda
bendamustine HCl

A nitrogen mustard compound that functions as an ALKYLATING ANTINEOPLASTIC AGENT and is used in the treatment of CHRONIC LYMPHOCYTIC LEUKEMIA and NON-HODGKIN'S LYMPHOMA.

Molecular weight: 358.26
Formula: C16H21Cl2N3O2
CLOGP: 3.24
LIPINSKI: 0
HAC: 5
HDO: 1
TPSA: 58.36
ALOGS: -3.76
ROTB: 9

Status: ONP

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	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	1 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	6.26 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	0.22 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	4.49 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.05 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.41 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
March 20, 2008	FDA	CEPHALON

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
Progressive multifocal leukoencephalopathy	343.72	19.38	128	13493	11218	46661223
Febrile neutropenia	306.11	19.38	239	13382	94388	46578053
Neutropenia	300.39	19.38	282	13339	142922	46529519
Pancytopenia	253.88	19.38	205	13416	84853	46587588
Pyrexia	230.67	19.38	384	13237	348418	46324023
Cytomegalovirus infection	182.00	19.38	94	13527	18050	46654391
Diffuse large B-cell lymphoma	165.27	19.38	63	13558	5875	46666566
Thrombocytopenia	157.37	19.38	189	13432	126392	46546049
Neutrophil count decreased	149.50	19.38	114	13507	43312	46629129
Chronic lymphocytic leukaemia	138.73	19.38	46	13575	2854	46669587
Diffuse large B-cell lymphoma recurrent	136.81	19.38	39	13582	1453	46670988
Plasma cell myeloma	132.04	19.38	107	13514	44371	46628070
Lymphocyte count decreased	127.00	19.38	84	13537	25505	46646936
B-cell lymphoma recurrent	123.45	19.38	28	13593	404	46672037
Cytopenia	103.96	19.38	49	13572	7719	46664722
Blood lactate dehydrogenase increased	98.58	19.38	66	13555	20434	46652007
Tumour lysis syndrome	94.85	19.38	45	13576	7191	46665250
Platelet count decreased	84.91	19.38	124	13497	99900	46572541
Diffuse large B-cell lymphoma refractory	78.59	19.38	23	13598	941	46671500
Product use in unapproved indication	73.84	19.38	110	13511	90163	46582278
Prescribed underdose	73.29	19.38	45	13576	12008	46660433
Lymphopenia	72.95	19.38	49	13572	15244	46657197
Hypogammaglobulinaemia	71.83	19.38	34	13587	5404	46667037
Autoimmune haemolytic anaemia	66.80	19.38	30	13591	4228	46668213
Bone marrow failure	64.92	19.38	60	13561	29609	46642832
Arthralgia	64.30	19.38	14	13607	364589	46307852
Pneumocystis jirovecii pneumonia	63.64	19.38	45	13576	15203	46657238
Disease progression	63.15	19.38	103	13518	91197	46581244
Therapy partial responder	61.00	19.38	29	13592	4653	46667788
Pneumonia	59.70	19.38	242	13379	376078	46296363
Off label use	56.89	19.38	240	13381	379601	46292840
White blood cell count decreased	56.26	19.38	110	13511	112121	46560320
Erythropoiesis abnormal	54.00	19.38	13	13608	246	46672195
Cytomegalovirus chorioretinitis	53.01	19.38	19	13602	1488	46670953
CD4 lymphocytes decreased	51.78	19.38	19	13602	1591	46670850
Cytokine release syndrome	50.44	19.38	28	13593	6195	46666246
Extravasation	50.20	19.38	20	13601	2095	46670346
Cytomegalovirus infection reactivation	49.68	19.38	18	13603	1454	46670987
Fear of injection	48.93	19.38	24	13597	4123	46668318
Headache	48.70	19.38	41	13580	478311	46194130
Pain	48.41	19.38	41	13580	476907	46195534
Gastrointestinal fungal infection	48.40	19.38	12	13609	258	46672183
Varicella zoster virus infection	48.22	19.38	20	13601	2323	46670118
Herpes zoster	47.49	19.38	77	13544	67795	46604646
Non-small cell lung cancer	45.68	19.38	21	13600	3123	46669318
Mantle cell lymphoma	43.37	19.38	13	13608	578	46671863
Infusion related reaction	43.37	19.38	93	13528	101115	46571326
B-cell lymphoma refractory	43.17	19.38	9	13612	85	46672356
Leukopenia	43.09	19.38	74	13547	68269	46604172
Venoocclusive liver disease	42.52	19.38	22	13599	4229	46668212
Hepatitis B	42.46	19.38	21	13600	3672	46668769
Myelosuppression	42.39	19.38	27	13594	7676	46664765
Sinus polyp	41.63	19.38	11	13610	307	46672134
Rash	41.26	19.38	209	13412	356303	46316138
Chills	40.87	19.38	88	13533	95944	46576497
Myelodysplastic syndrome	40.77	19.38	35	13586	15676	46656765
Hypertensive cardiomyopathy	39.77	19.38	10	13611	228	46672213
Drug hypersensitivity	39.74	19.38	11	13610	243814	46428627
Drug interaction	39.62	19.38	6	13615	203088	46469353
Lymphoma transformation	38.46	19.38	9	13612	150	46672291
Plasma cell leukaemia	38.08	19.38	14	13607	1179	46671262
Sepsis	37.99	19.38	106	13515	135908	46536533
Infusion site irritation	36.51	19.38	11	13610	498	46671943
Enterococcal sepsis	36.49	19.38	14	13607	1326	46671115
Lymphoma	36.47	19.38	27	13594	9786	46662655
Cerebral aspergillosis	35.84	19.38	10	13611	344	46672097
Rash maculo-papular	35.13	19.38	42	13579	27832	46644609
Toxic skin eruption	35.03	19.38	29	13592	12358	46660083
Drug ineffective	34.25	19.38	94	13527	677744	45994697
Hypercalcaemia	33.84	19.38	36	13585	21010	46651431
JC virus infection	33.57	19.38	14	13607	1648	46670793
Nasal abscess	33.40	19.38	8	13613	148	46672293
B-cell lymphoma	32.81	19.38	17	13604	3277	46669164
Platelet count abnormal	32.58	19.38	16	13605	2756	46669685
Agranulocytosis	32.28	19.38	36	13585	22149	46650292
Therapy responder	31.29	19.38	9	13612	346	46672095
Chronic lymphocytic leukaemia recurrent	31.19	19.38	8	13613	198	46672243
Abdominal discomfort	30.56	19.38	4	13617	151161	46521280
Febrile bone marrow aplasia	30.37	19.38	21	13600	6841	46665600
Haemolytic anaemia	29.85	19.38	24	13597	9818	46662623
Cytomegalovirus colitis	29.71	19.38	13	13608	1722	46670719
Atrial fibrillation	29.17	19.38	81	13540	103509	46568932
Pneumonia fungal	29.10	19.38	17	13604	4143	46668298
Dizziness	29.03	19.38	34	13587	340380	46332061
Gait disturbance	28.99	19.38	4	13617	145259	46527182
Mucosal erosion	28.99	19.38	12	13609	1386	46671055
Condition aggravated	28.77	19.38	18	13603	245034	46427407
Product dose omission issue	28.59	19.38	7	13614	168513	46503928
Neutrophil count abnormal	28.37	19.38	14	13607	2436	46670005
Peripheral swelling	27.94	19.38	6	13615	158065	46514376
VIth nerve paresis	26.96	19.38	6	13615	79	46672362
Listeria sepsis	26.89	19.38	9	13612	574	46671867
Respiratory tract infection	26.60	19.38	38	13583	29934	46642507
Anxiety	26.46	19.38	10	13611	181947	46490494
Leukaemic lymphoma	26.42	19.38	6	13615	87	46672354
General physical health deterioration	26.40	19.38	84	13537	115685	46556756
Feeling abnormal	26.03	19.38	3	13618	125057	46547384
Malignant neoplasm progression	25.90	19.38	58	13563	64868	46607573
Insomnia	25.82	19.38	8	13613	164916	46507525
Nonspecific reaction	25.76	19.38	12	13609	1838	46670603
Haematotoxicity	25.59	19.38	19	13602	6914	46665527
Enterococcal infection	25.46	19.38	19	13602	6968	46665473
Infusion site extravasation	25.44	19.38	17	13604	5239	46667202
Alopecia scarring	25.31	19.38	6	13615	106	46672335
Infusion site pain	25.17	19.38	22	13599	10085	46662356
Oral fungal infection	25.02	19.38	13	13608	2521	46669920
Seborrhoeic dermatitis	24.78	19.38	9	13612	732	46671709
Hypoglossal nerve paresis	24.33	19.38	6	13615	126	46672315
Splenic marginal zone lymphoma recurrent	24.17	19.38	4	13617	8	46672433
Urinary tract infection bacterial	23.92	19.38	15	13606	4150	46668291
Infusion site phlebitis	23.91	19.38	5	13616	48	46672393
Pneumonitis	23.72	19.38	35	13586	28385	46644056
Fall	22.00	19.38	39	13582	329058	46343383
Mucosal inflammation	21.71	19.38	40	13581	38936	46633505
Nasopharyngitis	21.51	19.38	9	13612	153989	46518452
Bronchiolitis obliterans syndrome	21.11	19.38	5	13616	88	46672353
Schistocytosis	20.93	19.38	4	13617	23	46672418
Varicella zoster oesophagitis	20.25	19.38	4	13617	28	46672413
Second primary malignancy	19.85	19.38	16	13605	6568	46665873
Hypertension	19.70	19.38	17	13604	196339	46476102
Mantle cell lymphoma recurrent	19.68	19.38	5	13616	119	46672322
Varicella zoster gastritis	19.67	19.38	4	13617	33	46672408
Paraneoplastic pemphigus	19.67	19.38	4	13617	33	46672408
Blood immunoglobulin G decreased	19.64	19.38	10	13611	1858	46670583

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
Febrile neutropenia	453.62	16.66	463	20849	106230	29824936
Progressive multifocal leukoencephalopathy	345.62	16.66	155	21157	8858	29922308
Pyrexia	293.12	16.66	644	20668	293845	29637321
Neutropenia	236.19	16.66	367	20945	128173	29802993
Tumour lysis syndrome	185.29	16.66	115	21197	12770	29918396
Chronic lymphocytic leukaemia	178.65	16.66	80	21232	4548	29926618
Lymphocyte count decreased	164.29	16.66	124	21188	18931	29912235
Cytomegalovirus infection	161.06	16.66	134	21178	23540	29907626
Myelodysplastic syndrome	159.25	16.66	121	21191	18657	29912509
Neutrophil count decreased	154.38	16.66	170	21142	42284	29888882
Diffuse large B-cell lymphoma	141.42	16.66	81	21231	7760	29923406
Pancytopenia	140.98	16.66	232	21080	84820	29846346
Product use in unapproved indication	137.20	16.66	212	21100	73481	29857685
Cytomegalovirus chorioretinitis	121.38	16.66	55	21257	3213	29927953
Thrombocytopenia	117.93	16.66	284	21028	136760	29794406
End stage renal disease	116.17	16.66	70	21242	7365	29923801
Prescribed underdose	110.88	16.66	69	21243	7690	29923476
Disease progression	105.19	16.66	197	21115	79677	29851489
B-cell lymphoma recurrent	100.17	16.66	31	21281	612	29930554
Infusion related reaction	99.32	16.66	133	21179	40431	29890735
Mantle cell lymphoma	97.86	16.66	38	21274	1503	29929663
Neutropenic sepsis	97.76	16.66	74	21238	11335	29919831
Cytopenia	94.80	16.66	64	21248	8192	29922974
Autoimmune haemolytic anaemia	92.67	16.66	49	21263	4010	29927156
B-cell lymphoma	90.56	16.66	50	21262	4460	29926706
Off label use	89.42	16.66	382	20930	248908	29682258
Extravasation	88.21	16.66	37	21275	1791	29929375
Chills	83.72	16.66	169	21143	72169	29858997
Second primary malignancy	79.57	16.66	52	21260	6304	29924862
Hepatitis B reactivation	72.17	16.66	37	21275	2840	29928326
Squamous cell carcinoma	71.70	16.66	59	21253	10191	29920975
Myelosuppression	70.61	16.66	51	21261	7271	29923895
Acute myeloid leukaemia	68.67	16.66	74	21238	17932	29913234
Infusion site extravasation	67.95	16.66	34	21278	2479	29928687
Diffuse large B-cell lymphoma recurrent	67.69	16.66	32	21280	2060	29929106
Pneumonia	66.37	16.66	435	20877	333871	29597295
Bone marrow failure	65.86	16.66	93	21219	29692	29901474
Rash	64.79	16.66	289	21023	191600	29739566
Pneumocystis jirovecii pneumonia	64.66	16.66	70	21242	17050	29914116
Septic shock	61.31	16.66	138	21174	63469	29867697
Basal cell carcinoma	61.21	16.66	66	21246	16002	29915164
Therapy partial responder	58.29	16.66	35	21277	3656	29927510
Drug interaction	58.25	16.66	35	21277	199533	29731633
Cytokine release syndrome	56.90	16.66	51	21261	9882	29921284
Chronic lymphocytic leukaemia recurrent	55.33	16.66	18	21294	420	29930746
Malignant neoplasm progression	54.86	16.66	143	21169	72144	29859022
Toxicity to various agents	54.68	16.66	29	21283	177154	29754012
Infection	52.78	16.66	148	21164	77926	29853240
Endocarditis noninfective	52.00	16.66	13	21299	111	29931055
White blood cell count decreased	50.85	16.66	153	21159	83794	29847372
Product dose omission issue	50.12	16.66	4	21308	91627	29839539
Plasma cell myeloma	48.20	16.66	113	21199	53349	29877817
Lymphoma transformation	48.01	16.66	13	21299	156	29931010
Headache	45.26	16.66	38	21274	182268	29748898
Arthralgia	43.70	16.66	21	21291	135770	29795396
Atypical pneumonia	43.46	16.66	26	21286	2698	29928468
Lymphopenia	43.15	16.66	50	21262	13113	29918053
Infusion site phlebitis	42.40	16.66	9	21303	33	29931133
Lymphadenopathy	42.31	16.66	68	21244	24308	29906858
Rash maculo-papular	41.54	16.66	69	21243	25349	29905817
Squamous cell carcinoma of skin	41.19	16.66	41	21271	9054	29922112
Phlebitis	40.34	16.66	28	21284	3747	29927419
Sepsis	40.27	16.66	208	21104	146187	29784979
Mantle cell lymphoma recurrent	40.06	16.66	14	21298	409	29930757
Neoplasm progression	39.41	16.66	56	21256	17967	29913199
Pain	38.12	16.66	40	21272	172601	29758565
Peripheral T-cell lymphoma unspecified	37.06	16.66	14	21298	513	29930653
Hypogammaglobulinaemia	36.24	16.66	30	21282	5222	29925944
Overdose	35.95	16.66	8	21304	84329	29846837
Platelet count decreased	35.82	16.66	160	21152	105969	29825197
Hypertension	35.76	16.66	21	21291	121333	29809833
Leukopenia	34.58	16.66	103	21209	56056	29875110
Aplasia pure red cell	34.44	16.66	30	21282	5596	29925570
Somnolence	34.25	16.66	13	21299	96750	29834416
Human polyomavirus infection	34.21	16.66	14	21298	636	29930530
Enterococcal infection	33.47	16.66	35	21277	8189	29922977
Cerebrovascular accident	33.47	16.66	9	21303	83468	29847698
Cytomegalovirus syndrome	33.01	16.66	9	21303	111	29931055
Pneumonia cytomegaloviral	32.87	16.66	22	21290	2774	29928392
Procalcitonin increased	32.82	16.66	16	21296	1102	29930064
Pain in extremity	32.57	16.66	19	21293	110202	29820964
Metastases to muscle	32.05	16.66	10	21302	203	29930963
Metastases to retroperitoneum	31.82	16.66	10	21302	208	29930958
Haemolysis	31.65	16.66	32	21280	7199	29923967
Rhabdomyolysis	31.58	16.66	4	21308	63576	29867590
Paraneoplastic pemphigus	31.43	16.66	8	21304	74	29931092
Fall	31.06	16.66	51	21261	181821	29749345
Infusion site irritation	30.90	16.66	9	21303	143	29931023
Cell-mediated cytotoxicity	30.90	16.66	7	21305	37	29931129
Dermatitis exfoliative	30.83	16.66	32	21280	7424	29923742
Insomnia	30.68	16.66	14	21298	93322	29837844
Seizure	30.51	16.66	16	21296	98459	29832707
Anaemia	30.38	16.66	252	21060	207740	29723426
Pneumonitis	30.35	16.66	63	21249	27391	29903775
Pneumocystis jirovecii infection	30.03	16.66	16	21296	1329	29929837
Blood stem cell harvest failure	29.71	16.66	6	21306	16	29931150
Dizziness	29.41	16.66	59	21253	194850	29736316
Depression	29.05	16.66	14	21298	90423	29840743
Anxiety	28.74	16.66	14	21298	89857	29841309
Serum sickness	28.33	16.66	17	21295	1773	29929393
Cytomegalovirus gastritis	28.25	16.66	9	21303	196	29930970
Intentional product use issue	27.51	16.66	72	21240	36368	29894798
Metastases to spleen	27.38	16.66	10	21302	333	29930833
Metastases to bone marrow	26.91	16.66	11	21301	498	29930668
Blood pressure decreased	26.79	16.66	84	21228	46991	29884175
Haemolytic anaemia	26.29	16.66	34	21278	9976	29921190
CD4 lymphocytes decreased	26.06	16.66	17	21295	2053	29929113
Adenocarcinoma	25.91	16.66	16	21296	1757	29929409
Blood bilirubin decreased	25.85	16.66	9	21303	260	29930906
Stevens-Johnson syndrome	25.19	16.66	45	21267	17511	29913655
Injection site phlebitis	25.17	16.66	6	21306	41	29931125
Bacteraemia	25.09	16.66	42	21270	15518	29915648
Blood lactate dehydrogenase increased	24.82	16.66	49	21263	20552	29910614
Haematotoxicity	24.65	16.66	26	21286	6144	29925022
Sphingomonas paucimobilis infection	24.57	16.66	6	21306	46	29931120
Cardiac failure congestive	24.30	16.66	15	21297	84392	29846774
Drug ineffective for unapproved indication	24.07	16.66	34	21278	10846	29920320
Infusion site induration	24.03	16.66	8	21304	201	29930965
Cytomegalovirus colitis	23.92	16.66	17	21295	2362	29928804
Peripheral swelling	23.71	16.66	7	21305	61067	29870099
Cytomegalovirus test positive	23.46	16.66	20	21292	3625	29927541
Agitation	23.30	16.66	5	21307	54068	29877098
Infusion site reaction	23.13	16.66	11	21301	717	29930449
JC polyomavirus test positive	22.19	16.66	10	21302	576	29930590
Fatigue	22.00	16.66	136	21176	320537	29610629
Polyneuropathy	21.91	16.66	34	21278	11789	29919377
Marginal zone lymphoma recurrent	21.54	16.66	5	21307	30	29931136
Lymphoma	21.47	16.66	31	21281	10090	29921076
Herpes zoster	21.42	16.66	58	21254	29885	29901281
Hypoglycaemia	21.39	16.66	5	21307	50976	29880190
Neuropathy peripheral	21.35	16.66	103	21209	70372	29860794
Type IV hypersensitivity reaction	21.07	16.66	12	21300	1136	29930030
Muscle spasms	20.88	16.66	10	21302	64828	29866338
Myositis	20.87	16.66	31	21281	10346	29920820
Oedema peripheral	20.66	16.66	27	21285	105805	29825361
Metastases to meninges	20.58	16.66	12	21300	1187	29929979
Hepatitis viral	20.56	16.66	9	21303	484	29930682
Splenic marginal zone lymphoma	20.18	16.66	5	21307	41	29931125
Tumour flare	20.03	16.66	9	21303	515	29930651
Acquired C1 inhibitor deficiency	19.99	16.66	4	21308	10	29931156
Mixed dementia	19.92	16.66	7	21305	208	29930958
Bradycardia	19.77	16.66	11	21301	65515	29865651
International normalised ratio increased	19.41	16.66	5	21307	47734	29883432
Dermatitis exfoliative generalised	19.26	16.66	16	21296	2799	29928367
Gastroenteritis sapovirus	19.13	16.66	6	21306	124	29931042
Cytomegalovirus infection reactivation	18.98	16.66	13	21299	1702	29929464
Mucosal inflammation	18.82	16.66	56	21256	30438	29900728
Encephalitis cytomegalovirus	18.80	16.66	8	21304	401	29930765
Cytomegalovirus enterocolitis	18.77	16.66	10	21302	830	29930336
Gastrointestinal haemorrhage	18.76	16.66	19	21293	83427	29847739
Hyperthermia	18.66	16.66	29	21283	10070	29921096
Nocardiosis	18.34	16.66	17	21295	3438	29927728
Nephrogenic diabetes insipidus	18.03	16.66	11	21301	1182	29929984
Neoplasm recurrence	17.98	16.66	13	21299	1854	29929312
Haemophagocytic lymphohistiocytosis	17.93	16.66	28	21284	9763	29921403
Vision blurred	17.74	16.66	4	21308	41812	29889354
Retinitis	17.65	16.66	7	21305	293	29930873
H1N1 influenza	17.48	16.66	10	21302	954	29930212
Hospitalisation	17.34	16.66	5	21307	44314	29886852
Infusion site swelling	17.30	16.66	12	21300	1604	29929562
Skin toxicity	17.27	16.66	16	21296	3233	29927933
Encephalitis	17.12	16.66	22	21290	6414	29924752
Nervous system disorder	16.86	16.66	32	21280	13037	29918129
Aggression	16.77	16.66	3	21309	36904	29894262
Cardio-respiratory arrest	16.74	16.66	10	21302	57296	29873870
Cerebral aspergillosis	16.72	16.66	11	21301	1347	29929819

Pharmacologic Action:

Source	Code	Description
ATC	L01AA09	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS ALKYLATING AGENTS Nitrogen mustard analogues
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	D009676	Noxae

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Chronic lymphoid leukemia, disease	indication	92814006
Follicular non-Hodgkin's lymphoma	indication	308121000
Indolent B-Cell Lymphoma	indication
Mantle cell lymphoma	off-label use	443487006
Fluid volume disorder	contraindication	1860003
Hyperkalemia	contraindication	14140009
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Acute infectious disease	contraindication	63171007
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
Neutropenic disorder	contraindication	303011007	DOID:1227
Bone marrow depression	contraindication	307762000
Breastfeeding (mother)	contraindication	413712001
Smokes tobacco daily	contraindication	449868002
Chemotherapy-Induced Hyperuricemia	contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.61	acidic
pKa2	6.18	Basic
pKa3	2.83	Basic

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/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	Dec. 7, 2022	TREATMENT OF PATIENTS WITH CLL AND TREATMENT OF PATIENTS WITH INDOLENT B-CELL NHL THAT HAS PROGRESSED DURING OR WITHIN SIX MONTHS OF TREATMENT WITH RITUXIMAB OR A RITUXIMAB CONTAINING REGIMEN

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Histone deacetylase 3	Enzyme	O15379	HDAC3_HUMAN		IC50	7.60	CHEMBL
Histone deacetylase 1	Enzyme	Q13547	HDAC1_HUMAN		IC50	7.77	CHEMBL
Histone deacetylase 2	Enzyme	Q92769	HDAC2_HUMAN		IC50	8.05	CHEMBL
Histone deacetylase 10	Enzyme	Q969S8	HDA10_HUMAN		IC50	7.14	CHEMBL
Histone deacetylase 8	Enzyme	Q9BY41	HDAC8_HUMAN		IC50	6.97	CHEMBL
Histone deacetylase 6	Enzyme	Q9UBN7	HDAC6_HUMAN		IC50	8.22	CHEMBL
DNA	DNA			OTHER			DRUG LABEL	DRUG LABEL

External reference:

ID	Source
9266D9P3PQ	UNII
4027339	VUID
N0000179513	NUI
D07085	KEGG_DRUG
3543-75-7	SECONDARY_CAS_RN
4027339	VANDF
C0525079	UMLSCUI
CHEBI:135515	CHEBI
CHEMBL487253	ChEMBL_ID
CHEMBL1201734	ChEMBL_ID
DB06769	DRUGBANK_ID
D000069461	MESH_DESCRIPTOR_UI
5228	INN_ID
65628	PUBCHEM_CID
7478	IUPHAR_LIGAND_ID
1114693	RXNORM
132929	MMSL
241056	MMSL
25220	MMSL
275320	MMSL
d07121	MMSL
006925	NDDF
006926	NDDF
427812009	SNOMEDCT_US
428012008	SNOMEDCT_US
430082006	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
BELRAPZO	HUMAN PRESCRIPTION DRUG LABEL	1	42367-521	INJECTION	100 mg	INTRAVENOUS	NDA	27 sections
Bendeka	HUMAN PRESCRIPTION DRUG LABEL	1	63459-348	INJECTION, SOLUTION	25 mg	INTRAVENOUS	NDA	31 sections
TREANDA	HUMAN PRESCRIPTION DRUG LABEL	1	63459-390	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 mg	INTRAVENOUS	NDA	27 sections
TREANDA	HUMAN PRESCRIPTION DRUG LABEL	1	63459-391	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	NDA	27 sections
TREANDA	HUMAN PRESCRIPTION DRUG LABEL	1	63459-395	INJECTION, SOLUTION, CONCENTRATE	45 mg	INTRAVENOUS	NDA	27 sections
TREANDA	HUMAN PRESCRIPTION DRUG LABEL	1	63459-396	INJECTION, SOLUTION, CONCENTRATE	180 mg	INTRAVENOUS	NDA	27 sections