bendamustine 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 ┬ÁM/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

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

FDA Adverse Event Reporting System (Male)

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

Pharmacologic Action:

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 (View source of the data)

DiseaseRelationSNOMED_IDDOID
Chronic lymphoid leukemia, disease indication 92814006
Follicular non-Hodgkin's lymphoma indication 308121000
Indolent B-Cell Lymphoma indication
Mantle cell lymphoma off-label use 443487006
Fluid volume disorder contraindication 1860003
Hyperkalemia contraindication 14140009
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Acute infectious disease contraindication 63171007
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Breastfeeding (mother) contraindication 413712001
Smokes tobacco daily contraindication 449868002
Chemotherapy-Induced Hyperuricemia contraindication

Acid dissociation constants calculated using MoKa v3.0.0

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

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation 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 3 Enzyme IC50 7.60 CHEMBL
Histone deacetylase 1 Enzyme IC50 7.77 CHEMBL
Histone deacetylase 2 Enzyme IC50 8.05 CHEMBL
Histone deacetylase 10 Enzyme IC50 7.14 CHEMBL
Histone deacetylase 8 Enzyme IC50 6.97 CHEMBL
Histone deacetylase 6 Enzyme IC50 8.22 CHEMBL
DNA DNA OTHER DRUG LABEL DRUG LABEL

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
BELRAPZO HUMAN PRESCRIPTION DRUG LABEL 1 42367-521 INJECTION 100 mg INTRAVENOUS NDA 27 sections
Bendeka HUMAN PRESCRIPTION DRUG LABEL 1 63459-348 INJECTION, SOLUTION 25 mg INTRAVENOUS NDA 31 sections
TREANDA HUMAN PRESCRIPTION DRUG LABEL 1 63459-390 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 25 mg INTRAVENOUS NDA 27 sections
TREANDA HUMAN PRESCRIPTION DRUG LABEL 1 63459-391 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS NDA 27 sections
TREANDA HUMAN PRESCRIPTION DRUG LABEL 1 63459-395 INJECTION, SOLUTION, CONCENTRATE 45 mg INTRAVENOUS NDA 27 sections
TREANDA HUMAN PRESCRIPTION DRUG LABEL 1 63459-396 INJECTION, SOLUTION, CONCENTRATE 180 mg INTRAVENOUS NDA 27 sections