bendamustine 🐶 Veterinary Use | 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
Sept. 27, 2010	PMDA	SymBio Pharmaceuticals Limited

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	425.89	20.89	148	13745	11309	50579922
Neutropenia	328.86	20.89	293	13600	147672	50443559
Febrile neutropenia	286.15	20.89	227	13666	97440	50493791
Pancytopenia	258.34	20.89	201	13692	83829	50507402
Pyrexia	235.45	20.89	393	13500	379810	50211421
Cytomegalovirus infection	194.23	20.89	96	13797	17866	50573365
Diffuse large B-cell lymphoma recurrent	187.42	20.89	50	13843	1545	50589686
Thrombocytopenia	186.10	20.89	201	13692	127472	50463759
Diffuse large B-cell lymphoma	146.38	20.89	56	13837	5606	50585625
Myelosuppression	145.39	20.89	72	13821	13445	50577786
Cytopenia	141.91	20.89	62	13831	8713	50582518
Neutrophil count decreased	138.85	20.89	109	13784	45917	50545314
Blood lactate dehydrogenase increased	123.03	20.89	73	13820	19489	50571742
Off label use	114.21	20.89	336	13557	474090	50117141
Disease progression	114.12	20.89	136	13757	95730	50495501
B-cell lymphoma recurrent	105.24	20.89	24	13869	379	50590852
Platelet count decreased	100.81	20.89	131	13762	100595	50490636
Tumour lysis syndrome	96.38	20.89	45	13848	7376	50583855
Lymphocyte count decreased	89.60	20.89	67	13826	26240	50564991
Product use in unapproved indication	89.49	20.89	133	13760	115686	50475545
Hypogammaglobulinaemia	84.83	20.89	38	13855	5661	50585570
Diffuse large B-cell lymphoma refractory	78.12	20.89	23	13870	1023	50590208
Arthralgia	76.72	20.89	14	13879	438688	50152543
JC virus infection	73.41	20.89	25	13868	1790	50589441
Autoimmune haemolytic anaemia	70.36	20.89	30	13863	3969	50587262
Cytomegalovirus infection reactivation	67.91	20.89	26	13867	2605	50588626
Prescribed underdose	66.63	20.89	46	13847	15903	50575328
Pneumocystis jirovecii pneumonia	65.31	20.89	44	13849	14619	50576612
Therapy partial responder	64.66	20.89	33	13860	6558	50584673
CD4 lymphocytes decreased	64.33	20.89	21	13872	1318	50589913
Lymphopenia	62.79	20.89	44	13849	15577	50575654
Pneumonia	62.17	20.89	236	13657	378165	50213066
Cytokine release syndrome	61.64	20.89	35	13858	8599	50582632
Pain	61.53	20.89	42	13851	578861	50012370
Erythropoiesis abnormal	53.64	20.89	13	13880	270	50590961
Extravasation	52.45	20.89	20	13873	1982	50589249
Varicella zoster virus infection	51.63	20.89	21	13872	2468	50588763
Abdominal discomfort	51.57	20.89	3	13890	231638	50359593
Cytomegalovirus chorioretinitis	50.34	20.89	18	13875	1489	50589742
Myelodysplastic syndrome	50.31	20.89	38	13855	15094	50576137
Gastrointestinal fungal infection	49.21	20.89	12	13881	256	50590975
Bone marrow failure	48.21	20.89	48	13845	27576	50563655
Rash maculo-papular	47.81	20.89	47	13846	26594	50564637
Venoocclusive liver disease	46.70	20.89	23	13870	4238	50586993
Herpes zoster	45.83	20.89	75	13818	70711	50520520
White blood cell count decreased	43.75	20.89	98	13795	116624	50474607
B-cell lymphoma refractory	43.72	20.89	9	13884	85	50591146
Sepsis	43.70	20.89	106	13787	132819	50458412
Headache	43.61	20.89	45	13848	506490	50084741
Sinus polyp	42.29	20.89	11	13882	307	50590924
Hypertensive cardiomyopathy	42.11	20.89	10	13883	190	50591041
Non-small cell lung cancer	41.85	20.89	19	13874	2918	50588313
Fear of injection	41.58	20.89	24	13869	6079	50585152
Plasma cell leukaemia	41.12	20.89	14	13879	1001	50590230
Cerebral aspergillosis	40.73	20.89	11	13882	356	50590875
Agranulocytosis	40.70	20.89	39	13854	21382	50569849
Chills	40.59	20.89	85	13808	96602	50494629
Mucosal inflammation	39.76	20.89	52	13841	40090	50551141
Lymphoma transformation	39.35	20.89	9	13884	144	50591087
Malignant neoplasm progression	38.57	20.89	68	13825	68056	50523175
Lymphoma	38.48	20.89	27	13866	9574	50581657
Enterococcal sepsis	38	20.89	14	13879	1261	50589970
Leukopenia	36.43	20.89	66	13827	67462	50523769
Haematotoxicity	35.89	20.89	24	13869	7871	50583360
Rash	35.49	20.89	223	13670	437248	50153983
Condition aggravated	35.02	20.89	19	13874	297039	50294192
Infusion site irritation	34.94	20.89	11	13882	614	50590617
Toxic skin eruption	34.65	20.89	27	13866	11224	50580007
Nasal abscess	34.36	20.89	8	13885	139	50591092
Drug hypersensitivity	34.34	20.89	13	13880	250997	50340234
Neuropathy peripheral	33.77	20.89	79	13814	96678	50494553
Drug interaction	33.48	20.89	7	13886	199614	50391617
Atrial fibrillation	33.27	20.89	81	13812	101664	50489567
Febrile bone marrow aplasia	33.14	20.89	21	13872	6290	50584941
Platelet count abnormal	33.08	20.89	16	13877	2833	50588398
Peripheral swelling	32.98	20.89	8	13885	205928	50385303
Hypercalcaemia	32.56	20.89	36	13857	23316	50567915
Therapy responder	32.22	20.89	9	13884	331	50590900
Neutrophil count abnormal	32.20	20.89	15	13878	2444	50588787
Enterococcal infection	31.43	20.89	21	13872	6877	50584354
Mucosal erosion	30.66	20.89	12	13881	1275	50589956
Hepatitis B	30.12	20.89	16	13877	3450	50587781
Nasopharyngitis	29.92	20.89	8	13885	192919	50398312
Product dose omission issue	29.71	20.89	7	13886	183831	50407400
Insomnia	29.59	20.89	6	13887	174859	50416372
Pneumonia fungal	29.46	20.89	17	13876	4303	50586928
Anaemia	29.35	20.89	142	13751	252314	50338917
Swelling	28.15	20.89	10	13883	200862	50390369
Urinary tract infection bacterial	27.39	20.89	16	13877	4143	50587088
VIth nerve paresis	27.32	20.89	6	13887	79	50591152
Dizziness	27.31	20.89	33	13860	346336	50244895
Listeria sepsis	27.10	20.89	9	13884	596	50590635
Leukaemic lymphoma	26.98	20.89	6	13887	84	50591147
Drug ineffective	26.86	20.89	125	13768	819208	49772023
Second primary malignancy	26.68	20.89	19	13874	6895	50584336
Respiratory tract infection	26.45	20.89	38	13855	31979	50559252
Anxiety	26.36	20.89	8	13885	177598	50413633
Oral fungal infection	25.95	20.89	13	13880	2482	50588749
Hypoglossal nerve paresis	25.67	20.89	6	13887	106	50591125
Alopecia scarring	25.52	20.89	6	13887	109	50591122
Seborrhoeic dermatitis	24.56	20.89	9	13884	798	50590433
Feeling abnormal	24.17	20.89	3	13890	125489	50465742
Splenic marginal zone lymphoma recurrent	24.09	20.89	4	13889	9	50591222
Infusion site phlebitis	23.94	20.89	5	13888	51	50591180
Nonspecific reaction	23.75	20.89	11	13882	1768	50589463
Aplasia	23.36	20.89	14	13879	3799	50587432
Exposure during pregnancy	23.04	20.89	3	13890	121012	50470219
Cytomegalovirus colitis	22.91	20.89	11	13882	1916	50589315
Bronchopulmonary aspergillosis	22.90	20.89	18	13875	7574	50583657
Musculoskeletal stiffness	22.60	20.89	4	13889	128477	50462754
Infusion site pain	22.55	20.89	22	13871	12324	50578907
Acute myeloid leukaemia	22.34	20.89	24	13869	15050	50576181
Abdominal pain upper	22.19	20.89	8	13885	159301	50431930
Hepatitis B reactivation	22.08	20.89	11	13882	2076	50589155
Infusion site extravasation	22.04	20.89	17	13876	6959	50584272
Multiple organ dysfunction syndrome	21.98	20.89	45	13848	50292	50540939
Cryoglobulinaemia	21.52	20.89	7	13886	434	50590797
Disease recurrence	21.43	20.89	27	13866	20054	50571177
Stevens-Johnson syndrome	21.25	20.89	28	13865	21724	50569507

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	379.40	18.44	434	20853	111806	29441434
Progressive multifocal leukoencephalopathy	289.00	18.44	136	21151	8583	29544657
Pyrexia	237.36	18.44	589	20698	287033	29266207
Neutropenia	199.55	18.44	347	20940	131364	29421876
Disease progression	184.21	18.44	259	21028	81657	29471583
Cytomegalovirus infection	176.80	18.44	141	21146	23074	29530166
Off label use	172.53	18.44	540	20747	300260	29252980
Product use in unapproved indication	172.53	18.44	259	21028	86616	29466624
End stage renal disease	158.64	18.44	87	21200	7577	29545663
Myelosuppression	156.92	18.44	102	21185	12125	29541115
Tumour lysis syndrome	142.82	18.44	101	21186	13783	29539457
Myelodysplastic syndrome	141.74	18.44	111	21176	17683	29535557
Cytomegalovirus chorioretinitis	140.56	18.44	61	21226	3177	29550063
Diffuse large B-cell lymphoma recurrent	136.33	18.44	56	21231	2541	29550699
Cytopenia	130.82	18.44	84	21203	9775	29543465
Pancytopenia	126.82	18.44	220	21067	82948	29470292
Neutrophil count decreased	121.21	18.44	153	21134	43414	29509826
Prescribed underdose	112.45	18.44	70	21217	7716	29545524
Thrombocytopenia	106.11	18.44	272	21015	134551	29418689
Lymphocyte count decreased	103.75	18.44	96	21191	19175	29534065
B-cell lymphoma recurrent	96.57	18.44	30	21257	593	29552647
Extravasation	94.43	18.44	38	21249	1634	29551606
Infusion related reaction	94.39	18.44	136	21151	43750	29509490
Hepatitis B reactivation	93.69	18.44	46	21241	3183	29550057
Neutropenic sepsis	86.61	18.44	70	21217	11657	29541583
Second primary malignancy	86.16	18.44	56	21231	6649	29546591
Septic shock	77.00	18.44	151	21136	62409	29490831
Basal cell carcinoma	73.64	18.44	75	21212	16835	29536405
Malignant neoplasm progression	73.07	18.44	163	21124	73696	29479544
Acute myeloid leukaemia	71.48	18.44	73	21214	16440	29536800
Hypogammaglobulinaemia	70.23	18.44	47	21240	5860	29547380
Chills	70.14	18.44	157	21130	71143	29482097
Autoimmune haemolytic anaemia	66.95	18.44	39	21248	3809	29549431
Lymphadenopathy	63.39	18.44	84	21203	24965	29528275
Cytokine release syndrome	62.31	18.44	61	21226	13058	29540182
Chronic lymphocytic leukaemia recurrent	61.96	18.44	19	21268	359	29552881
Pneumonia	61.58	18.44	417	20870	319755	29233485
Infusion site extravasation	60.59	18.44	34	21253	3093	29550147
Drug interaction	59.73	18.44	34	21253	197351	29355889
Diffuse large B-cell lymphoma	58.44	18.44	43	21244	6233	29547007
Lymphoma transformation	57.09	18.44	15	21272	157	29553083
Therapy partial responder	56.18	18.44	39	21248	5160	29548080
Toxicity to various agents	55.33	18.44	28	21259	173633	29379607
Infection	55.29	18.44	150	21137	76601	29476639
Rash	55.16	18.44	276	21011	189543	29363697
Squamous cell carcinoma	55.02	18.44	51	21236	10200	29543040
Pneumocystis jirovecii pneumonia	54.87	18.44	64	21223	16715	29536525
Endocarditis noninfective	51.44	18.44	13	21274	115	29553125
Product dose omission issue	51.32	18.44	5	21282	96378	29456862
Bacteraemia	51.28	18.44	61	21226	16262	29536978
Lymphopenia	50.00	18.44	55	21232	13478	29539762
Bone marrow failure	47.58	18.44	77	21210	27372	29525868
Arthralgia	45.22	18.44	22	21265	139595	29413645
Rash maculo-papular	44.66	18.44	70	21217	24219	29529021
Human polyomavirus infection	43.54	18.44	17	21270	674	29552566
Headache	43.31	18.44	37	21250	173970	29379270
Cytomegalovirus infection reactivation	42.98	18.44	28	21259	3336	29549904
Neoplasm progression	41.92	18.44	59	21228	18553	29534687
Infusion site phlebitis	40.92	18.44	9	21278	40	29553200
Cytomegalovirus test positive	40.12	18.44	27	21260	3396	29549844
Neuropathy peripheral	39.82	18.44	127	21160	70900	29482340
Blood lactate dehydrogenase increased	39.04	18.44	58	21229	19151	29534089
Sepsis	38.95	18.44	204	21083	142478	29410762
Pain	38.50	18.44	40	21247	171392	29381848
Platelet count decreased	38.32	18.44	163	21124	104509	29448731
Drug ineffective for unapproved indication	38.02	18.44	49	21238	14165	29539075
Squamous cell carcinoma of skin	37.57	18.44	40	21247	9446	29543794
Haematotoxicity	37.25	18.44	34	21253	6665	29546575
Enterococcal infection	36.59	18.44	37	21250	8231	29545009
Overdose	35.78	18.44	7	21280	79812	29473428
Peripheral T-cell lymphoma unspecified	35.76	18.44	13	21274	422	29552818
Somnolence	34.95	18.44	12	21275	93943	29459297
Chronic lymphocytic leukaemia	34.07	18.44	25	21262	3608	29549632
Cerebrovascular accident	33.94	18.44	7	21280	76904	29476336
White blood cell count decreased	33.80	18.44	134	21153	83228	29470012
Pneumonia cytomegaloviral	33.47	18.44	22	21265	2660	29550580
Primary amyloidosis	33.21	18.44	9	21278	107	29553133
Cytomegalovirus syndrome	33.13	18.44	9	21278	108	29553132
Fall	32.78	18.44	48	21239	177130	29376110
Insomnia	31.89	18.44	12	21275	88749	29464491
Atypical pneumonia	31.75	18.44	21	21266	2566	29550674
Metastases to muscle	31.57	18.44	10	21277	211	29553029
Metastases to retroperitoneum	31.31	18.44	10	21277	217	29553023
Hypertension	31.25	18.44	23	21264	116591	29436649
Pain in extremity	30.62	18.44	21	21266	110412	29442828
Cell-mediated cytotoxicity	30.51	18.44	7	21280	39	29553201
Mantle cell lymphoma recurrent	30.49	18.44	12	21275	486	29552754
Rhabdomyolysis	30.24	18.44	4	21283	60804	29492436
Cytomegalovirus colitis	30.20	18.44	20	21267	2449	29550791
CD4 lymphocytes decreased	29.94	18.44	17	21270	1581	29551659
Dizziness	29.89	18.44	57	21230	189627	29363613
Blood pressure decreased	29.87	18.44	86	21201	45391	29507849
Procalcitonin increased	29.51	18.44	17	21270	1625	29551615
Intentional product use issue	29.51	18.44	82	21205	42416	29510824
Dermatitis exfoliative generalised	29.47	18.44	21	21266	2895	29550345
Anaemia	29.00	18.44	245	21042	200706	29352534
B-cell lymphoma	28.62	18.44	23	21264	3795	29549445
Paraneoplastic pemphigus	28.43	18.44	7	21280	55	29553185
Serum sickness	28.37	18.44	17	21270	1748	29551492
Depression	28.18	18.44	13	21274	85134	29468106
Seizure	28.17	18.44	16	21271	93107	29460133
Infusion site irritation	28.06	18.44	9	21278	198	29553042
Lymphoma	28.06	18.44	35	21252	9793	29543447
Phlebitis	27.79	18.44	22	21265	3554	29549686
Cytomegalovirus gastritis	27.60	18.44	9	21278	209	29553031
COVID-19	27.53	18.44	72	21215	35942	29517298
Metastases to bone marrow	27.37	18.44	11	21276	471	29552769
Adenocarcinoma	27.03	18.44	16	21271	1609	29551631
Anxiety	26.79	18.44	14	21273	85351	29467889
Injection site phlebitis	26.70	18.44	6	21281	30	29553210
Pneumonitis	26.69	18.44	61	21226	27983	29525257
Polyneuropathy	26.59	18.44	38	21249	12114	29541126
Nephrogenic diabetes insipidus	26.55	18.44	14	21273	1125	29552115
Humoral immune defect	26.49	18.44	7	21280	75	29553165
Metastases to spleen	26.27	18.44	10	21277	370	29552870
Pneumocystis jirovecii infection	26.05	18.44	15	21272	1433	29551807
Peripheral swelling	25.75	18.44	7	21280	63732	29489508
Blood bilirubin decreased	25.55	18.44	9	21278	266	29552974
Haemolysis	25.22	18.44	28	21259	6928	29546312
Cytomegalovirus enterocolitis	24.84	18.44	12	21275	801	29552439
Pneumonia bacterial	24.66	18.44	32	21255	9311	29543929
Cytomegalovirus hepatitis	24.56	18.44	9	21278	299	29552941
Sphingomonas paucimobilis infection	24.50	18.44	6	21281	46	29553194
Infusion site induration	23.90	18.44	8	21279	202	29553038
Fat tissue increased	23.44	18.44	9	21278	341	29552899
Abdominal lymphadenopathy	23.42	18.44	11	21276	689	29552551
Secondary immunodeficiency	23.31	18.44	9	21278	346	29552894
Stevens-Johnson syndrome	22.95	18.44	42	21245	16455	29536785
Infusion site reaction	22.79	18.44	11	21276	733	29552507
Tumour flare	22.66	18.44	10	21277	542	29552698
JC polyomavirus test positive	22.25	18.44	10	21277	566	29552674
Condition aggravated	22.13	18.44	45	21242	146250	29406990
Bronchopulmonary aspergillosis	21.89	18.44	35	21252	12309	29540931
International normalised ratio increased	21.86	18.44	3	21284	44369	29508871
Dermatitis exfoliative	21.82	18.44	25	21262	6400	29546840
Neoplasm recurrence	21.76	18.44	15	21272	1962	29551278
Bradycardia	21.75	18.44	10	21277	65619	29487621
Marginal zone lymphoma recurrent	21.48	18.44	5	21282	30	29553210
Aplasia pure red cell	21.47	18.44	23	21264	5468	29547772
Muscle spasms	21.43	18.44	10	21277	65072	29488168
Nervous system disorder	21.20	18.44	35	21252	12639	29540601
COVID-19 pneumonia	21.16	18.44	30	21257	9492	29543748
Pseudomonas infection	20.95	18.44	32	21255	10820	29542420
Myositis	20.82	18.44	31	21256	10252	29542988
Type IV hypersensitivity reaction	20.69	18.44	12	21275	1162	29552078
Hospitalisation	20.67	18.44	4	21283	45984	29507256
Cardiac failure congestive	20.64	18.44	15	21272	76566	29476674
Oedema peripheral	20.17	18.44	27	21260	103530	29449710
Agitation	20.05	18.44	6	21281	51298	29501942
JC virus infection	19.96	18.44	14	21273	1883	29551357
Acquired C1 inhibitor deficiency	19.95	18.44	4	21283	10	29553230
Haemolytic anaemia	19.94	18.44	29	21258	9390	29543850
Ototoxicity	19.93	18.44	13	21274	1552	29551688
Nausea	19.59	18.44	125	21162	289130	29264110
Leukopenia	19.42	18.44	85	21202	55118	29498122
Renal tubular necrosis	19.36	18.44	36	21251	14279	29538961
Cerebral aspergillosis	19.09	18.44	12	21275	1344	29551896
Pneumonia mycoplasmal	19.07	18.44	9	21278	570	29552670
Nocardiosis	19.02	18.44	17	21270	3243	29549997
Gait disturbance	18.95	18.44	15	21272	73334	29479906
Lung opacity	18.80	18.44	12	21275	1380	29551860
Gastroenteritis sapovirus	18.79	18.44	6	21281	130	29553110
Hyperthermia	18.48	18.44	28	21259	9402	29543838

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
Progressive multifocal leukoencephalopathy	648.25	16.29	263	29922	17969	64450578
Febrile neutropenia	585.90	16.29	569	29616	187088	64281459
Neutropenia	395.73	16.29	522	29663	239102	64229445
Pyrexia	377.07	16.29	814	29371	557830	63910717
Cytomegalovirus infection	335.95	16.29	212	29973	36987	64431560
Myelosuppression	288.41	16.29	164	30021	23666	64444881
Product use in unapproved indication	262.58	16.29	366	29819	176252	64292295
Diffuse large B-cell lymphoma recurrent	257.28	16.29	84	30101	3062	64465485
Off label use	256.99	16.29	761	29424	632045	63836502
Pancytopenia	254.48	16.29	324	29861	142985	64325562
Cytopenia	250.03	16.29	129	30056	15342	64453205
Disease progression	246.34	16.29	317	29868	141363	64327184
Thrombocytopenia	230.15	16.29	391	29794	223410	64245137
Neutrophil count decreased	212.33	16.29	219	29966	76977	64391570
Prescribed underdose	183.72	16.29	111	30074	17904	64450643
Cytomegalovirus chorioretinitis	181.82	16.29	73	30112	4839	64463708
Myelodysplastic syndrome	176.50	16.29	127	30058	27452	64441095
Tumour lysis syndrome	175.94	16.29	111	30074	19329	64449218
End stage renal disease	162.51	16.29	85	30100	10390	64458157
Lymphocyte count decreased	156.56	16.29	139	30046	40560	64427987
Pneumonia	155.39	16.29	593	29592	558983	63909564
Diffuse large B-cell lymphoma	152.02	16.29	81	30104	10280	64458267
B-cell lymphoma recurrent	150.35	16.29	41	30144	791	64467756
Autoimmune haemolytic anaemia	134.87	16.29	66	30119	7010	64461537
Cytokine release syndrome	133.45	16.29	96	30089	20733	64447814
Malignant neoplasm progression	130.31	16.29	208	29977	112663	64355884
Hypogammaglobulinaemia	130.29	16.29	73	30112	10226	64458321
Arthralgia	119.55	16.29	30	30155	442230	64026317
Pneumocystis jirovecii pneumonia	117.60	16.29	100	30085	27534	64441013
Blood lactate dehydrogenase increased	115.48	16.29	107	30078	32971	64435576
Second primary malignancy	110.51	16.29	70	30115	12267	64456280
Pain	107.61	16.29	63	30122	553448	63915099
Platelet count decreased	103.82	16.29	237	29948	167474	64301073
Cytomegalovirus infection reactivation	101.72	16.29	51	30134	5705	64462842
Lymphopenia	101.38	16.29	89	30096	25568	64442979
Septic shock	98.70	16.29	177	30008	105260	64363287
Hepatitis B reactivation	97.38	16.29	47	30138	4842	64463705
Therapy partial responder	96.44	16.29	60	30125	10188	64458359
Headache	93.70	16.29	67	30118	529400	63939147
Acute myeloid leukaemia	90.41	16.29	86	30099	27377	64441170
CD4 lymphocytes decreased	86.02	16.29	35	30150	2400	64466147
Sepsis	82.48	16.29	266	29919	230075	64238472
Neuropathy peripheral	79.33	16.29	172	30013	117353	64351194
Neutropenic sepsis	78.75	16.29	74	30111	23198	64445349
JC virus infection	78.36	16.29	36	30149	3319	64465228
Chills	76.23	16.29	186	29999	137078	64331469
Rash maculo-papular	75.01	16.29	101	30084	46925	64421622
Drug interaction	74.93	16.29	38	30147	362045	64106502
Infusion related reaction	74.05	16.29	206	29979	164261	64304286
Basal cell carcinoma	71.51	16.29	80	30105	30758	64437789
Enterococcal infection	69.07	16.29	55	30130	13811	64454736
Cytomegalovirus test positive	66.53	16.29	37	30148	5107	64463440
Product dose omission issue	63.79	16.29	8	30177	194739	64273808
Lymphadenopathy	63.64	16.29	93	30092	46593	64421954
COVID-19	63.04	16.29	111	30074	65029	64403518
Erythropoiesis abnormal	62.68	16.29	18	30167	422	64468125
Chronic lymphocytic leukaemia recurrent	62.46	16.29	19	30166	547	64468000
Bone marrow failure	61.74	16.29	93	30092	47859	64420688
Peripheral swelling	58.76	16.29	13	30172	209140	64259407
Rheumatoid arthritis	58.31	16.29	5	30180	164289	64304258
White blood cell count decreased	58	16.29	184	30001	157653	64310894
Dizziness	57.66	16.29	70	30115	430093	64038454
Diffuse large B-cell lymphoma refractory	56.96	16.29	21	30164	1103	64467444
Toxicity to various agents	55.54	16.29	53	30132	363460	64105087
Cerebral aspergillosis	55.27	16.29	23	30162	1670	64466877
Lymphoma transformation	54.57	16.29	14	30171	211	64468336
Cytomegalovirus colitis	52.85	16.29	29	30156	3899	64464648
Squamous cell carcinoma	52.57	16.29	47	30138	13822	64454725
Insomnia	52.24	16.29	14	30171	197822	64270725
Human polyomavirus infection	51.50	16.29	19	30166	1000	64467547
Haematotoxicity	51.47	16.29	45	30140	12851	64455696
Endocarditis noninfective	51.11	16.29	13	30172	189	64468358
Hypertension	50.97	16.29	29	30156	259232	64209315
Bronchopulmonary aspergillosis	50.34	16.29	53	30132	19032	64449515
Fall	49.59	16.29	74	30111	416752	64051795
Infection	49.36	16.29	194	29991	184686	64283861
Lymphoma	48.45	16.29	45	30140	13896	64454651
Anaemia	46.66	16.29	320	29865	378360	64090187
Drug hypersensitivity	46.17	16.29	27	30158	237788	64230759
COVID-19 pneumonia	45.62	16.29	47	30138	16457	64452090
Condition aggravated	45.38	16.29	65	30120	372361	64096186
Varicella zoster virus infection	44.98	16.29	26	30159	3862	64464685
Bacteraemia	44.74	16.29	59	30126	26852	64441695
Overdose	44.64	16.29	10	30175	159556	64308991
Febrile bone marrow aplasia	44.37	16.29	39	30146	11216	64457331
Drug ineffective for unapproved indication	43.85	16.29	63	30122	31070	64437477
Anxiety	43.80	16.29	20	30165	202629	64265918
Mantle cell lymphoma recurrent	43.80	16.29	14	30171	476	64468071
Swelling	42.94	16.29	11	30174	160207	64308340
Somnolence	42.63	16.29	21	30164	203624	64264923
Pneumonitis	42.62	16.29	81	30104	50284	64418263
Pneumonia cytomegaloviral	42.33	16.29	26	30159	4313	64464234
Oral fungal infection	42.29	16.29	23	30162	3038	64465509
Gait disturbance	42.14	16.29	14	30171	172141	64296406
Agranulocytosis	42.07	16.29	69	30116	38160	64430387
Arthropathy	42.06	16.29	4	30181	120963	64347584
Leukopenia	40.86	16.29	122	30063	101120	64367427
Squamous cell carcinoma of skin	40.63	16.29	38	30147	11838	64456709
Chronic lymphocytic leukaemia	39.93	16.29	25	30160	4290	64464257
Aplasia	39.91	16.29	30	30155	6923	64461624
Atrial fibrillation	39.72	16.29	172	30013	170917	64297630
Therapeutic product effect decreased	39.62	16.29	4	30181	115347	64353200
Extravasation	38.75	16.29	22	30163	3158	64465389
Gastrointestinal fungal infection	38.48	16.29	12	30173	376	64468171
Herpes zoster	38.40	16.29	102	30083	79085	64389462
Pneumonia bacterial	38.32	16.29	41	30144	14994	64453553
Abdominal discomfort	37.86	16.29	19	30166	182303	64286244
Pain in extremity	37.80	16.29	52	30133	303033	64165514
Pseudomonas infection	37.41	16.29	44	30141	17839	64450708
JC polyomavirus test positive	37.38	16.29	16	30169	1246	64467301
Plasma cell leukaemia	37.32	16.29	17	30168	1536	64467011
Peripheral T-cell lymphoma unspecified	36.78	16.29	13	30172	604	64467943
Primary amyloidosis	36.75	16.29	9	30176	111	64468436
Feeling abnormal	36.13	16.29	9	30176	133593	64334954
Venoocclusive liver disease	36.11	16.29	33	30152	9982	64458565
Atypical pneumonia	35.28	16.29	25	30160	5269	64463278
Encephalitis cytomegalovirus	33.98	16.29	14	30171	991	64467556
Musculoskeletal stiffness	33.90	16.29	8	30177	123198	64345349
Muscle spasms	33.59	16.29	12	30173	141011	64327536
Neoplasm progression	33.57	16.29	65	30120	40899	64427648
Malaise	33.52	16.29	86	30099	396161	64072386
Toxic skin eruption	33.18	16.29	43	30142	19241	64449306
Cell-mediated cytotoxicity	32.93	16.29	7	30178	43	64468504
Sinus polyp	32.58	16.29	11	30174	445	64468102
Abdominal lymphadenopathy	32.45	16.29	14	30171	1112	64467435
Procalcitonin increased	32.44	16.29	18	30167	2473	64466074
Paraneoplastic pemphigus	32.28	16.29	8	30177	104	64468443
Metastases to muscle	31.98	16.29	10	30175	316	64468231
Dermatitis exfoliative	31.40	16.29	31	30154	10321	64458226
Metastases to retroperitoneum	30.66	16.29	10	30175	363	64468184
Fatigue	30.20	16.29	216	29969	748514	63720033
Plasmacytoma	29.85	16.29	20	30165	3850	64464697
Nasal abscess	29.55	16.29	8	30177	150	64468397
Rhabdomyolysis	29.46	16.29	4	30181	91722	64376825
Mantle cell lymphoma	28.96	16.29	13	30172	1135	64467412
Hepatitis B	28.86	16.29	26	30159	7719	64460828
Depression	28.80	16.29	26	30159	183265	64285282
Hypoglycaemia	28.68	16.29	4	30181	89888	64378659
Cytomegalovirus syndrome	28.65	16.29	9	30176	289	64468258
Metastases to bone marrow	28.48	16.29	11	30174	657	64467890
Dermatitis exfoliative generalised	28.47	16.29	23	30162	5893	64462654
Serum sickness	28.32	16.29	18	30167	3171	64465376
Seizure	28.28	16.29	22	30163	166870	64301677
Haemolysis	27.95	16.29	30	30155	11009	64457538
B-cell lymphoma	27.94	16.29	22	30163	5435	64463112
Colitis	27.86	16.29	75	30110	58599	64409948
Metastases to spleen	27.67	16.29	10	30175	496	64468051
Polyneuropathy	27.64	16.29	40	30145	19854	64448693
Infusion site extravasation	27.57	16.29	24	30161	6813	64461734
Adenocarcinoma	27.50	16.29	18	30167	3333	64465214
Inappropriate schedule of product administration	27.43	16.29	5	30180	92281	64376266
Nasopharyngitis	27.18	16.29	31	30154	196042	64272505
Enterococcal sepsis	27.06	16.29	16	30169	2478	64466069
Cytomegalovirus enterocolitis	26.90	16.29	13	30172	1342	64467205
Tumour flare	26.73	16.29	11	30174	776	64467771
Bradycardia	26.59	16.29	11	30174	118208	64350339
Splenomegaly	26.25	16.29	37	30148	17924	64450623
Pleural effusion	26.18	16.29	123	30062	126436	64342111
Balance disorder	26.16	16.29	4	30181	83922	64384625
Cerebrovascular accident	26.15	16.29	16	30169	137567	64330980
Arthritis	26.11	16.29	4	30181	83810	64384737
Hypercalcaemia	25.92	16.29	50	30135	31366	64437181
Exposure during pregnancy	25.89	16.29	3	30182	77672	64390875
Drug intolerance	25.76	16.29	30	30155	187962	64280585
Cytomegalovirus gastritis	25.59	16.29	9	30176	412	64468135
Nephrogenic diabetes insipidus	25.57	16.29	14	30171	1873	64466674
Drug resistance	25.53	16.29	53	30132	35049	64433498
Coma	25.50	16.29	5	30180	87610	64380937
Blood pressure increased	25.34	16.29	26	30159	172526	64296021
Pneumocystis jirovecii infection	25.23	16.29	15	30170	2346	64466201
Therapy responder	25.19	16.29	9	30176	432	64468115
Blood pressure decreased	25.06	16.29	93	30092	86106	64382441
Contusion	25.00	16.29	11	30174	113954	64354593
Neutrophil count abnormal	24.86	16.29	16	30169	2880	64465667
Hepatitis E	24.83	16.29	15	30170	2416	64466131
Intentional overdose	24.43	16.29	6	30179	89938	64378609
Weight increased	24.25	16.29	39	30146	213309	64255238
Radiation injury	24.06	16.29	10	30175	724	64467823
Injection site pain	24.05	16.29	11	30174	111397	64357150
Agitation	23.79	16.29	6	30179	88361	64380186
Leukaemic lymphoma	23.73	16.29	6	30179	85	64468462
Guillain-Barre syndrome	23.41	16.29	23	30162	7612	64460935
Neoplasm recurrence	23.41	16.29	17	30168	3722	64464825
Oedema peripheral	23.38	16.29	39	30146	210278	64258269
Haemolytic anaemia	23.36	16.29	33	30152	16020	64452527
Campylobacter gastroenteritis	23.05	16.29	11	30174	1105	64467442
Wound	23.04	16.29	4	30181	76473	64392074
Marginal zone lymphoma recurrent	22.96	16.29	5	30180	35	64468512
Fungal infection	22.93	16.29	50	30135	34201	64434346
Alopecia scarring	22.88	16.29	6	30179	99	64468448
Acute febrile neutrophilic dermatosis	22.83	16.29	16	30169	3313	64465234
Sphingomonas paucimobilis infection	22.71	16.29	6	30179	102	64468445
Hyperthermia	22.68	16.29	32	30153	15518	64453029
Venoocclusive disease	22.44	16.29	17	30168	3968	64464579
Cytomegalovirus hepatitis	22.39	16.29	9	30176	598	64467949
General physical health deterioration	22.35	16.29	168	30017	204257	64264290
Hypoglossal nerve paresis	22.34	16.29	6	30179	109	64468438
Fear of injection	22.33	16.29	20	30165	5892	64462655
Disease recurrence	22.24	16.29	47	30138	31463	64437084
International normalised ratio increased	22.05	16.29	5	30180	79162	64389385
Platelet count abnormal	21.96	16.29	17	30168	4095	64464452
Nervous system disorder	21.89	16.29	39	30146	23039	64445508
Nocardiosis	21.82	16.29	18	30167	4749	64463798
Stevens-Johnson syndrome	21.80	16.29	49	30136	34200	64434347
Chronic lymphocytic leukaemia refractory	21.80	16.29	6	30179	120	64468427
Acute kidney injury	21.58	16.29	312	29873	448928	64019619
Nausea	21.50	16.29	250	29935	785550	63682997
Infusion site phlebitis	21.47	16.29	6	30179	127	64468420
Intentional product use issue	21.44	16.29	95	30090	95269	64373278
Non-small cell lung cancer	21.42	16.29	18	30167	4872	64463675
Intentional product misuse	21.31	16.29	4	30181	72291	64396256
Aplasia pure red cell	21.26	16.29	21	30164	6993	64461554
Urticaria papular	21.26	16.29	6	30179	132	64468415
Obliterative bronchiolitis	21.10	16.29	14	30171	2651	64465896
VIth nerve paresis	21.09	16.29	6	30179	136	64468411
Acquired C1 inhibitor deficiency	20.89	16.29	4	30181	13	64468534
Chest pain	20.88	16.29	50	30135	235930	64232617
Cardio-respiratory arrest	20.80	16.29	10	30175	98383	64370164
Mixed dementia	20.74	16.29	7	30178	283	64468264
Gastroenteritis sapovirus	20.68	16.29	6	30179	146	64468401
Cardiomyopathy	20.49	16.29	40	30145	25316	64443231
Hospitalisation	20.45	16.29	5	30180	75202	64393345
Fungal oesophagitis	20.00	16.29	9	30176	790	64467757
Myositis	19.99	16.29	31	30154	16346	64452201
Mucosal erosion	19.92	16.29	12	30173	1922	64466625
Osteoarthritis	19.78	16.29	3	30182	63333	64405214
Hepatic enzyme increased	19.74	16.29	19	30166	129924	64338623
Fat tissue increased	19.54	16.29	9	30176	834	64467713
Mucosal inflammation	19.44	16.29	69	30116	62515	64406032
Vision blurred	19.37	16.29	9	30176	90307	64378240
Rash	19.14	16.29	311	29874	458238	64010309
Back pain	19.11	16.29	57	30128	250114	64218433
Coagulation factor V level decreased	19.09	16.29	8	30177	591	64467956
Discomfort	19.05	16.29	7	30178	80871	64387676
Suicidal ideation	18.94	16.29	4	30181	66538	64402009
Pneumonia fungal	18.83	16.29	22	30163	8855	64459692
Listeria sepsis	18.81	16.29	8	30177	613	64467934
Cardiac failure congestive	18.80	16.29	20	30165	130560	64337987
Blood immunoglobulin G decreased	18.64	16.29	13	30172	2670	64465877
Secondary immunodeficiency	18.47	16.29	13	30172	2711	64465836
Varicella zoster oesophagitis	18.37	16.29	4	30181	28	64468519
Myalgia	18.01	16.29	29	30156	158588	64309959
Renal tubular necrosis	18.01	16.29	35	30150	22075	64446472
Lymphoplasmacytoid lymphoma/immunocytoma refractory	17.93	16.29	3	30182	3	64468544
Varicella zoster gastritis	17.79	16.29	4	30181	33	64468514
B-cell lymphoma refractory	17.63	16.29	5	30180	112	64468435
Schistocytosis	17.48	16.29	4	30181	36	64468511
Pericarditis	17.31	16.29	4	30181	62512	64406035
Psoriasis	17.24	16.29	6	30179	71697	64396850
Hepatitis B e antigen positive	17.19	16.29	4	30181	39	64468508
Nonspecific reaction	17.03	16.29	11	30174	1992	64466555
Hyperpyrexia	16.89	16.29	16	30169	5061	64463486
Immune effector cell-associated neurotoxicity syndrome	16.70	16.29	12	30173	2583	64465964
Lung opacity	16.60	16.29	13	30172	3186	64465361
Cutaneous listeriosis	16.43	16.29	4	30181	48	64468499
Follicle centre lymphoma, follicular grade I, II, III recurrent	16.39	16.29	3	30182	7	64468540
Abdominal pain upper	16.35	16.29	36	30149	174994	64293553

FDA Adverse Event Reporting System (Pediatric)

None

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

Disease	Relation	SNOMED_ID	DOID
Chronic lymphoid leukemia, disease	indication	92814006
Follicular non-Hodgkin's lymphoma	indication	308121000
Treatment prior to tumor-specific T-cell infusion therapy	indication
Indolent B-Cell Lymphoma	indication
Diffuse large B-cell lymphoma refractory	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

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG/VIAL	TREANDA	CEPHALON	N022249	March 20, 2008	RX	POWDER	IV (INFUSION)	8791270	Jan. 12, 2026	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
180MG/2ML (90MG/ML)	TREANDA	CEPHALON	N022249	Sept. 13, 2013	DISCN	SOLUTION	IV (INFUSION)	8791270	Jan. 12, 2026	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
25MG/VIAL	TREANDA	CEPHALON	N022249	May 1, 2009	RX	POWDER	IV (INFUSION)	8791270	Jan. 12, 2026	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
45MG/0.5ML (90MG/ML)	TREANDA	CEPHALON	N022249	Sept. 13, 2013	DISCN	SOLUTION	IV (INFUSION)	8791270	Jan. 12, 2026	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	8791270	Jan. 12, 2026	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	8791270	Jan. 12, 2026	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	8791270	Jan. 12, 2026	FOR USE IN TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR NON-HODGKINS LYMPHOMA
100MG/VIAL	TREANDA	CEPHALON	N022249	March 20, 2008	RX	POWDER	IV (INFUSION)	8445524	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
100MG/VIAL	TREANDA	CEPHALON	N022249	March 20, 2008	RX	POWDER	IV (INFUSION)	8669279	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
100MG/VIAL	TREANDA	CEPHALON	N022249	March 20, 2008	RX	POWDER	IV (INFUSION)	8883836	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
100MG/VIAL	TREANDA	CEPHALON	N022249	March 20, 2008	RX	POWDER	IV (INFUSION)	9533955	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
100MG/VIAL	TREANDA	CEPHALON	N022249	March 20, 2008	RX	POWDER	IV (INFUSION)	9533955	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
25MG/VIAL	TREANDA	CEPHALON	N022249	May 1, 2009	RX	POWDER	IV (INFUSION)	8445524	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
25MG/VIAL	TREANDA	CEPHALON	N022249	May 1, 2009	RX	POWDER	IV (INFUSION)	8669279	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
25MG/VIAL	TREANDA	CEPHALON	N022249	May 1, 2009	RX	POWDER	IV (INFUSION)	8883836	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
25MG/VIAL	TREANDA	CEPHALON	N022249	May 1, 2009	RX	POWDER	IV (INFUSION)	9533955	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
25MG/VIAL	TREANDA	CEPHALON	N022249	May 1, 2009	RX	POWDER	IV (INFUSION)	9533955	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
180MG/2ML (90MG/ML)	TREANDA	CEPHALON	N022249	Sept. 13, 2013	DISCN	SOLUTION	IV (INFUSION)	8344006	Sept. 23, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
45MG/0.5ML (90MG/ML)	TREANDA	CEPHALON	N022249	Sept. 13, 2013	DISCN	SOLUTION	IV (INFUSION)	8344006	Sept. 23, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	11103483	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	11103483	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	9572796	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	9572796	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	9572797	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	9572797	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	11103483	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	11103483	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9572796	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9572796	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9572797	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9572797	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	8609707	Aug. 11, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	8609707	Aug. 11, 2031	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	8609707	Aug. 11, 2031	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	10052385	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	10052385	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9000021	March 15, 2033	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9034908	March 15, 2033	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9144568	March 15, 2033	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9572887	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9572887	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9579384	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9579384	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9597397	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9597397	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9597398	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9597399	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9597399	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

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

External reference:

ID	Source
4027339	VUID
N0000179513	NUI
D07085	KEGG_DRUG
3543-75-7	SECONDARY_CAS_RN
1114693	RXNORM
C0525079	UMLSCUI
CHEBI:135515	CHEBI
CHEMBL487253	ChEMBL_ID
DB06769	DRUGBANK_ID
CHEMBL1201734	ChEMBL_ID
D000069461	MESH_DESCRIPTOR_UI
65628	PUBCHEM_CID
7478	IUPHAR_LIGAND_ID
5228	INN_ID
9266D9P3PQ	UNII
132929	MMSL
241056	MMSL
25220	MMSL
275320	MMSL
d07121	MMSL
006925	NDDF
006926	NDDF
4027339	VANDF
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	29 sections
BELRAPZO	HUMAN PRESCRIPTION DRUG LABEL	1	42367-521	INJECTION	100 mg	INTRAVENOUS	NDA	29 sections
Bendeka	HUMAN PRESCRIPTION DRUG LABEL	1	63459-348	INJECTION, SOLUTION	25 mg	INTRAVENOUS	NDA	32 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