bendamustine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antineoplastic, alkylating agents, (beta-chloroethyl)amine derivatives 302 16506-27-7

Description:

MoleculeDescription

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:

PropertyValueReference
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 ยตM/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:

DateAgencyCompanyOrphan
March 20, 2008 FDA CEPHALON
Sept. 27, 2010 PMDA SymBio Pharmaceuticals Limited

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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|

DiseaseRelationSNOMED_IDDOID
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.61 acidic
pKa2 6.18 Basic
pKa3 2.83 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Histone deacetylase 2 Enzyme IC50 8.05 CHEMBL
Histone deacetylase 1 Enzyme IC50 7.77 CHEMBL
Histone deacetylase 3 Enzyme IC50 7.60 CHEMBL
Histone deacetylase 6 Enzyme IC50 8.22 CHEMBL
Histone deacetylase 8 Enzyme IC50 6.97 CHEMBL
Histone deacetylase 10 Enzyme IC50 7.14 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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