eltrombopag 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
thrombopoietin agonists 4399 496775-61-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • eltrombopag
  • SB 497115
  • revolade
  • eltrombopag olamine
  • ppromacta
  • eltrombopag choline
an oral, nonpeptide thrombopoietin receptor agonist
  • Molecular weight: 442.48
  • Formula: C25H22N4O4
  • CLOGP: 5.25
  • LIPINSKI: 1
  • HAC: 8
  • HDO: 3
  • TPSA: 114.59
  • ALOGS: -4.63
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Hosey CM, Chan R, Benet LZ
S (Water solubility) 0.00 mg/mL Bocci G, Oprea TI, Benet LZ
fu (Fraction unbound in plasma) 0 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K
BA (Bioavailability) 52 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,ACVRL1,AKT2,AKT3,ALK,AURKA,AURKB,AURKC,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK1,CDK2,CDK4,CDK5,CDK9,CSF1R,DDR1,DYRK1B,DYRK3,EGFR,EIF2AK3,EPHB4,ERBB2,FGFR1,FLT3,GRK2,GRK3,GSK3A,GSK3B,IKBKB,ITK,JAK1,JAK2,KDR,KIT,MAP2K6,MAP3K1,MAP3K11,MAP3K14,MAP3K2,MAP3K21,MAP3K3,MAP3K7,MAP3K8,MAP4K1,MAP4K3,MAPK1,MAPK10,MAPK12,MAPK7,MAPK8,MAPK9,MAPKAPK2,MAPKAPK5,MARK4,MELK,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM1,PIM2,PIM3,PLK1,PRKCD,PRKDC,PTK2,SGK1,SIK2,SIK3,STK10,STK33,SYK,TEK,TGFBR1,TTK,UHMK1,ULK1,ULK2,ZAP70 91
kinase-selectivity-class ACVR2A,ACVR2B,AXL,BRAF,CDK9,DDR1,DYRK1B,EIF2AK3,GRK2,MAP2K6,MAPK7,PRKDC,SIK2,STK33,TEK,TTK 16
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1

Approvals:

DateAgencyCompanyOrphan
March 11, 2010 EMA
Nov. 20, 2008 FDA NOVARTIS PHARMS CORP

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
Platelet count decreased 2031.60 18.78 819 16803 136150 90474675
Death 621.57 18.78 589 17033 455962 90154863
Platelet count increased 576.97 18.78 198 17424 20661 90590164
Platelet count abnormal 294.40 18.78 82 17540 4253 90606572
Thrombocytopenia 244.53 18.78 249 17373 208476 90402349
Myelofibrosis 241.59 18.78 57 17565 1510 90609315
Haemorrhage 222.93 18.78 149 17473 69220 90541605
Product use in unapproved indication 179.50 18.78 270 17352 335966 90274859
Gingival bleeding 168.81 18.78 74 17548 14829 90595996
Thrombocytosis 168.61 18.78 60 17562 6941 90603884
Petechiae 155.42 18.78 71 17551 15670 90595155
Bone marrow reticulin fibrosis 122.41 18.78 23 17599 190 90610635
Immune thrombocytopenia 112.66 18.78 54 17568 13272 90597553
Pulmonary embolism 107.82 18.78 130 17492 130690 90480135
Transplant dysfunction 107.56 18.78 40 17582 5242 90605583
Thrombosis 105.46 18.78 98 17524 73153 90537672
Epistaxis 96.62 18.78 100 17522 85025 90525800
Drug ineffective 93.41 18.78 520 17102 1383778 89227047
Mouth haemorrhage 92.35 18.78 41 17581 8460 90602365
Antiphospholipid syndrome 88.62 18.78 28 17594 2246 90608579
Therapy non-responder 87.71 18.78 120 17502 136584 90474241
Cerebral venous sinus thrombosis 87.41 18.78 28 17594 2348 90608477
Haemoglobin decreased 83.25 18.78 128 17494 161828 90448997
Cerebral venous thrombosis 79.79 18.78 26 17596 2302 90608523
Paroxysmal nocturnal haemoglobinuria 78.03 18.78 17 17605 311 90610514
Cerebral infarction 75.58 18.78 53 17569 26543 90584282
Deep vein thrombosis 75.37 18.78 91 17531 91529 90519296
Haemorrhage intracranial 72.56 18.78 42 17580 15120 90595705
Portal vein thrombosis 68.45 18.78 25 17597 3113 90607712
Myelodysplastic syndrome 62.54 18.78 43 17579 20860 90589965
Infusion related reaction 62.28 18.78 5 17617 416775 90194050
Mucosal haemorrhage 61.25 18.78 19 17603 1434 90609391
Drug hypersensitivity 60.60 18.78 9 17613 463600 90147225
Pain 60.45 18.78 63 17559 996278 89614547
Heavy menstrual bleeding 58.53 18.78 41 17581 20489 90590336
Acute graft versus host disease 58.20 18.78 26 17596 5442 90605383
Concomitant disease aggravated 55.37 18.78 32 17590 11486 90599339
Cytomegalovirus infection reactivation 55.18 18.78 28 17594 7772 90603053
Rheumatoid arthritis 52.40 18.78 5 17617 362609 90248216
Evans syndrome 49.03 18.78 12 17610 372 90610453
Platelet disorder 48.52 18.78 18 17604 2341 90608484
Glossodynia 47.67 18.78 4 17618 321775 90289050
Wound 47.07 18.78 3 17619 302977 90307848
Aplastic anaemia 46.20 18.78 30 17592 13239 90597586
Blood bilirubin increased 45.61 18.78 49 17573 43421 90567404
Sepsis 44.47 18.78 104 17518 179710 90431115
Headache 43.23 18.78 301 17321 862445 89748380
Acute myeloid leukaemia 42.69 18.78 34 17588 20606 90590219
Anaemia 40.98 18.78 156 17466 352646 90258179
Bone marrow myelogram abnormal 40.29 18.78 7 17615 35 90610790
Clonal evolution 40.26 18.78 8 17614 91 90610734
Mucocutaneous haemorrhage 38.72 18.78 8 17614 112 90610713
Pericarditis 38.30 18.78 4 17618 270147 90340678
Cytogenetic analysis abnormal 37.55 18.78 12 17610 998 90609827
Hepatic function abnormal 36.46 18.78 45 17577 46243 90564582
Swelling 36.42 18.78 18 17604 419040 90191785
Cerebral haemorrhage 36.37 18.78 39 17583 34483 90576342
White blood cell count increased 35.71 18.78 54 17568 67187 90543638
Wheezing 35.14 18.78 3 17619 238077 90372748
Intermenstrual bleeding 34.96 18.78 22 17600 9201 90601624
Systemic lupus erythematosus 33.85 18.78 14 17608 361882 90248943
Myalgia 33.59 18.78 92 17530 175033 90435792
Pancytopenia 32.42 18.78 72 17550 120191 90490634
Marrow hyperplasia 32.31 18.78 10 17612 749 90610076
Superior sagittal sinus thrombosis 31.72 18.78 10 17612 796 90610029
Therapeutic response decreased 31.61 18.78 60 17562 89669 90521156
Joint swelling 31.35 18.78 31 17591 503269 90107556
Jaundice 31.24 18.78 35 17587 32482 90578343
Blister 30.97 18.78 6 17616 254992 90355833
Mobility decreased 30.24 18.78 6 17616 250728 90360097
Serum colour abnormal 30.18 18.78 4 17618 0 90610825
Drug intolerance 29.72 18.78 26 17596 447565 90163260
Megakaryocytes increased 28.98 18.78 6 17616 85 90610740
Hepatitis G 28.85 18.78 6 17616 87 90610738
Asthma 28.77 18.78 6 17616 242154 90368671
Haemorrhagic diathesis 28.30 18.78 16 17606 5508 90605317
Mesenteric vein thrombosis 27.81 18.78 10 17612 1191 90609634
Disease progression 27.79 18.78 80 17542 156535 90454290
Purpura 27.72 18.78 23 17599 14755 90596070
Haematoma 27.64 18.78 36 17586 39012 90571813
Graft versus host disease 27.34 18.78 18 17604 8126 90602699
Subdural haematoma 27.33 18.78 24 17598 16621 90594204
Chronic lymphocytic leukaemia 27.26 18.78 13 17609 3157 90607668
Hepatic failure 27.15 18.78 36 17586 39692 90571133
Biopsy bone marrow abnormal 27.05 18.78 7 17615 273 90610552
Therapy partial responder 26.99 18.78 27 17595 22016 90588809
Blast cell count increased 26.94 18.78 8 17614 521 90610304
Chronic graft versus host disease 26.80 18.78 14 17608 4125 90606700
Discomfort 26.65 18.78 10 17612 274325 90336500
SARS-CoV-2 test positive 26.65 18.78 20 17602 11108 90599717
Cytomegalovirus infection 26.18 18.78 29 17593 26573 90584252
Drug ineffective for unapproved indication 25.27 18.78 46 17576 66598 90544227
Osteoarthritis 25.08 18.78 4 17618 195726 90415099
Ecchymosis 24.84 18.78 20 17602 12303 90598522
Lower respiratory tract infection 24.58 18.78 9 17613 250650 90360175
Leukocytosis 24.20 18.78 30 17592 30960 90579865
Head banging 24.05 18.78 7 17615 425 90610400
Pulmonary artery thrombosis 23.89 18.78 8 17614 771 90610054
Hypersensitivity 22.98 18.78 33 17589 454644 90156181
Reticulocytosis 22.87 18.78 6 17616 247 90610578
Spleen operation 22.64 18.78 3 17619 0 90610825
Embolism 22.62 18.78 17 17605 9464 90601361
Cytogenetic abnormality 22.28 18.78 7 17615 551 90610274
Stomatitis 22.09 18.78 13 17609 274685 90336140
Abdominal discomfort 21.87 18.78 37 17585 477291 90133534
Febrile neutropenia 21.73 18.78 74 17548 158275 90452550
Arterial thrombosis 21.60 18.78 9 17613 1591 90609234
Liver disorder 21.56 18.78 62 17560 121207 90489618
Splenectomy 21.50 18.78 7 17615 618 90610207
Lymphocyte count increased 21.45 18.78 12 17610 4047 90606778
Adenocarcinoma gastric 21.24 18.78 7 17615 642 90610183
Ill-defined disorder 21.11 18.78 5 17617 184886 90425939
Hepatic infection 20.92 18.78 7 17615 673 90610152
Wrong technique in product usage process 20.59 18.78 44 17578 71527 90539298
Cerebral thrombosis 20.56 18.78 9 17613 1794 90609031
Blast cell proliferation 20.56 18.78 3 17619 3 90610822
Megakaryocytes abnormal 20.51 18.78 4 17618 41 90610784
Type 2 diabetes mellitus 20.43 18.78 7 17615 203237 90407588
Sinusitis 20.36 18.78 22 17600 343066 90267759
Hospice care 20.10 18.78 16 17606 9688 90601137
Splenomegaly 19.96 18.78 18 17604 12906 90597919
Transaminases increased 19.93 18.78 30 17592 37162 90573663
Dyspnoea 19.87 18.78 96 17526 880859 89729966
Therapeutic product effect decreased 19.81 18.78 15 17607 277556 90333269
Weight increased 19.51 18.78 32 17590 417895 90192930
Intentional product use issue 19.30 18.78 9 17613 216883 90393942
Cerebral toxoplasmosis 19.29 18.78 8 17614 1397 90609428
Haemosiderosis 18.99 18.78 5 17617 209 90610616
Oral blood blister 18.86 18.78 4 17618 64 90610761

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
Platelet count decreased 1034.20 17.72 602 12798 137979 42469956
Death 490.40 17.72 664 12736 470521 42137414
Platelet count abnormal 334.92 17.72 97 13303 3552 42604383
Platelet count increased 270.40 17.72 108 13292 10595 42597340
Immune thrombocytopenia 182.93 17.72 83 13317 11133 42596802
Myelofibrosis 160.16 17.72 47 13353 1800 42606135
Therapy non-responder 159.65 17.72 133 13267 53226 42554709
Product use in unapproved indication 143.22 17.72 228 13172 184228 42423707
Drug ineffective 124.77 17.72 456 12944 629741 41978194
Petechiae 100.63 17.72 54 13346 10381 42597554
Platelet disorder 99.56 17.72 34 13366 2140 42605795
Acute myeloid leukaemia 87 17.72 65 13335 22191 42585744
Myelodysplastic syndrome 81.35 17.72 63 13337 22682 42585253
Epistaxis 75.70 17.72 99 13301 66727 42541208
Gingival bleeding 71.03 17.72 40 13360 8445 42599490
Thrombocytopenia 64.70 17.72 167 13233 190112 42417823
Bone marrow reticulin fibrosis 64.52 17.72 14 13386 150 42607785
Contusion 55.15 17.72 67 13333 41918 42566017
Haematological malignancy 47.20 17.72 14 13386 556 42607379
Liver disorder 45.27 17.72 59 13341 39585 42568350
Portal vein thrombosis 45.14 17.72 24 13376 4525 42603410
Clonal evolution 44.67 17.72 10 13390 125 42607810
Haemorrhage 44.25 17.72 73 13327 60490 42547445
Thrombocytosis 44.04 17.72 24 13376 4751 42603184
Paroxysmal nocturnal haemoglobinuria 43.82 17.72 10 13390 137 42607798
Disease progression 43.62 17.72 121 13279 143535 42464400
Cytogenetic abnormality 40.45 17.72 14 13386 917 42607018
Serum sickness 37.95 17.72 17 13383 2208 42605727
Toxicity to various agents 36.91 17.72 13 13387 229123 42378812
Haemorrhagic diathesis 32.13 17.72 17 13383 3172 42604763
Tooth dislocation 28.40 17.72 5 13395 15 42607920
Drug ineffective for unapproved indication 27.66 17.72 51 13349 46112 42561823
Acute myocardial infarction 27.29 17.72 58 13342 58107 42549828
Haemoglobin decreased 26.77 17.72 97 13303 132374 42475561
Therapy partial responder 26.35 17.72 32 13368 19989 42587946
Neutrophil count decreased 26.10 17.72 60 13340 63355 42544580
Oral blood blister 25.61 17.72 5 13395 30 42607905
Antiphospholipid syndrome 25.59 17.72 9 13391 618 42607317
Mucosal haemorrhage 25.29 17.72 12 13388 1778 42606157
Gingival hypertrophy 24.57 17.72 13 13387 2426 42605509
Hypoparathyroidism 24.31 17.72 9 13391 716 42607219
Hypotension 23.36 17.72 28 13372 257603 42350332
Drug interaction 23.18 17.72 30 13370 266969 42340966
Acute leukaemia 22.89 17.72 10 13390 1223 42606712
Ecchymosis 22.47 17.72 19 13381 7733 42600202
Splenic infarction 21.81 17.72 12 13388 2419 42605516
Mean platelet volume increased 21.62 17.72 8 13392 636 42607299
Dehydration 21.22 17.72 9 13391 141758 42466177
Cerebral venous thrombosis 21.16 17.72 9 13391 1032 42606903
Transplant dysfunction 20.75 17.72 13 13387 3330 42604605
Cushingoid 20.48 17.72 13 13387 3409 42604526
Chronic myelomonocytic leukaemia 20.30 17.72 8 13392 755 42607180
Blast cell count increased 20.04 17.72 9 13391 1176 42606759
Haemorrhagic disorder 20.01 17.72 8 13392 784 42607151
Deep vein thrombosis 19.65 17.72 61 13339 76896 42531039
Mouth haemorrhage 19.50 17.72 16 13384 6245 42601690
Cerebral infarction 19.38 17.72 35 13365 31134 42576801
Haemolytic anaemia 18.65 17.72 21 13379 12106 42595829
Cerebral haemorrhage 18.44 17.72 39 13361 38927 42569008
Aplastic anaemia 18.29 17.72 21 13379 12363 42595572
Oesophageal adenocarcinoma 18.29 17.72 8 13392 982 42606953
Mucocutaneous haemorrhage 18.27 17.72 5 13395 148 42607787
Hypercoagulation 18.13 17.72 9 13391 1470 42606465
Iron overload 17.82 17.72 9 13391 1526 42606409

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
Platelet count decreased 1881.69 16.60 937 22899 229506 110335957
Death 801.34 16.60 861 22975 698008 109867455
Platelet count increased 536.80 16.60 205 23631 26129 110539334
Platelet count abnormal 451.41 16.60 127 23709 6155 110559308
Myelofibrosis 329.06 16.60 85 23751 2966 110562497
Petechiae 253.41 16.60 116 23720 23201 110542262
Product use in unapproved indication 244.81 16.60 384 23452 446993 110118470
Thrombocytopenia 233.14 16.60 329 23507 348556 110216907
Immune thrombocytopenia 213.77 16.60 102 23734 22392 110543071
Therapy non-responder 213.02 16.60 213 23623 157094 110408369
Gingival bleeding 194.76 16.60 92 23744 19747 110545716
Drug ineffective 191.58 16.60 737 23099 1519803 109045660
Haemorrhage 187.54 16.60 167 23669 106525 110458938
Thrombocytosis 172.94 16.60 70 23766 10374 110555089
Myelodysplastic syndrome 149.85 16.60 96 23740 37388 110528075
Epistaxis 141.57 16.60 157 23679 130215 110435248
Acute myeloid leukaemia 141.05 16.60 93 23743 38017 110527446
Bone marrow reticulin fibrosis 138.08 16.60 28 23808 318 110565145
Transplant dysfunction 124.89 16.60 52 23784 8276 110557187
Haemoglobin decreased 98.12 16.60 185 23651 248542 110316921
Platelet disorder 94.64 16.60 34 23802 3641 110561822
Pulmonary embolism 90.19 16.60 164 23672 214310 110351153
Paroxysmal nocturnal haemoglobinuria 87.77 16.60 20 23816 406 110565057
Cerebral venous thrombosis 87.10 16.60 31 23805 3231 110562232
Clonal evolution 86.52 16.60 18 23818 234 110565229
Mucosal haemorrhage 81.77 16.60 29 23807 2991 110562472
Mouth haemorrhage 81.22 16.60 45 23791 13443 110552020
Antiphospholipid syndrome 78.99 16.60 27 23809 2496 110562967
Deep vein thrombosis 78.86 16.60 122 23714 139765 110425698
Pain 77.41 16.60 56 23780 954899 109610564
Disease progression 76.50 16.60 165 23671 243869 110321594
Portal vein thrombosis 76.30 16.60 35 23801 7023 110558440
Cerebral venous sinus thrombosis 75.36 16.60 27 23809 2868 110562595
Cerebral infarction 73.40 16.60 72 23764 51766 110513697
Acute graft versus host disease 69.52 16.60 40 23796 12841 110552622
Cytogenetic abnormality 67.20 16.60 20 23816 1182 110564281
Drug ineffective for unapproved indication 62.64 16.60 93 23743 102745 110462718
Haemorrhagic diathesis 62.17 16.60 31 23805 7477 110557986
Cerebral haemorrhage 59.97 16.60 72 23764 64896 110500567
Sepsis 58.45 16.60 179 23657 327167 110238296
Haemorrhage intracranial 56.18 16.60 48 23788 28921 110536542
Infusion related reaction 53.36 16.60 9 23827 381153 110184310
Thrombosis 53.33 16.60 89 23747 108573 110456890
Blood bilirubin increased 52.56 16.60 73 23763 75899 110489564
Rheumatoid arthritis 52.45 16.60 3 23833 299610 110265853
Cytomegalovirus infection reactivation 51.99 16.60 38 23798 18295 110547168
Joint swelling 49.25 16.60 17 23819 442828 110122635
Therapy partial responder 47.90 16.60 49 23787 37012 110528451
Synovitis 47.20 16.60 3 23833 274089 110291374
Concomitant disease aggravated 46.59 16.60 34 23802 16330 110549133
Gingival hypertrophy 45.32 16.60 21 23815 4310 110561153
Bone marrow myelogram abnormal 45.16 16.60 9 23827 93 110565370
Serum sickness 44.98 16.60 21 23815 4385 110561078
Evans syndrome 43.83 16.60 13 23823 759 110564704
Haemolytic anaemia 43.32 16.60 36 23800 20884 110544579
Drug hypersensitivity 43.16 16.60 22 23814 454068 110111395
Neutrophil count decreased 42.80 16.60 86 23750 120855 110444608
Ecchymosis 42.64 16.60 33 23803 17305 110548158
Aplastic anaemia 42.56 16.60 38 23798 24270 110541193
Serum colour abnormal 42.22 16.60 6 23830 3 110565460
Heavy menstrual bleeding 42.11 16.60 32 23804 16333 110549130
Chronic lymphocytic leukaemia 41.76 16.60 22 23814 5946 110559517
Haematological malignancy 40.42 16.60 13 23823 994 110564469
Mobility decreased 39.71 16.60 3 23833 237419 110328044
Asthma 39.59 16.60 4 23832 250287 110315176
Musculoskeletal stiffness 38.30 16.60 7 23829 279815 110285648
Wheezing 38.07 16.60 5 23831 255225 110310238
Hospice care 37.99 16.60 27 23809 12446 110553017
White blood cell count increased 36.85 16.60 71 23765 96771 110468692
Glossodynia 36.58 16.60 3 23833 222001 110343462
Wound 36.43 16.60 4 23832 234433 110331030
Acute leukaemia 36.23 16.60 14 23822 1835 110563628
Pericarditis 36.00 16.60 3 23833 219111 110346352
Intermenstrual bleeding 36.00 16.60 21 23815 6913 110558550
Pancytopenia 35.87 16.60 113 23723 209500 110355963
Splenomegaly 34.62 16.60 34 23802 24464 110540999
Oral blood blister 34.01 16.60 7 23829 86 110565377
Splenectomy 33.98 16.60 11 23825 859 110564604
Acute myocardial infarction 33.82 16.60 63 23773 83714 110481749
Liver disorder 33.43 16.60 86 23750 142157 110423306
Hepatic function abnormal 32.19 16.60 64 23772 89231 110476232
Graft versus host disease 32.13 16.60 29 23807 18777 110546686
Bone marrow failure 31.94 16.60 50 23786 57798 110507665
Superior sagittal sinus thrombosis 30.94 16.60 11 23825 1142 110564321
Megakaryocytes increased 30.91 16.60 7 23829 138 110565325
Anaemia 30.46 16.60 212 23624 546874 110018589
Chronic graft versus host disease 30.03 16.60 21 23815 9436 110556027
Off label use 29.97 16.60 471 23365 1499714 109065749
Hyperbilirubinaemia 29.96 16.60 35 23801 30636 110534827
Dyspnoea 29.89 16.60 130 23706 1106742 109458721
Contusion 29.66 16.60 114 23722 233247 110332216
Marrow hyperplasia 29.60 16.60 12 23824 1784 110563679
Haemorrhagic disorder 29.49 16.60 12 23824 1801 110563662
Swelling 29.12 16.60 20 23816 351021 110214442
Therapeutic response decreased 28.77 16.60 64 23772 96435 110469028
Toxicity to various agents 28.58 16.60 37 23799 480518 110084945
Chronic myeloid leukaemia 27.78 16.60 15 23821 4258 110561205
Pneumonia fungal 27.70 16.60 24 23812 14730 110550733
Mean platelet volume increased 27.41 16.60 11 23825 1593 110563870
Hypersensitivity 27.38 16.60 28 23808 403970 110161493
Blast cell count increased 27.19 16.60 11 23825 1626 110563837
Megakaryocytes abnormal 27.07 16.60 6 23830 107 110565356
Hepatitis G 26.91 16.60 6 23830 110 110565353
Osteoarthritis 26.24 16.60 4 23832 182619 110382844
Mucocutaneous haemorrhage 26.07 16.60 7 23829 284 110565179
White blood cell count decreased 25.90 16.60 108 23728 229282 110336181
Lower respiratory tract infection 25.87 16.60 10 23826 243096 110322367
Purpura 25.80 16.60 29 23807 24359 110541104
Cytopenia 25.56 16.60 32 23804 30084 110535379
Febrile neutropenia 25.40 16.60 135 23701 316632 110248831
Weight increased 25.27 16.60 32 23804 419612 110145851
Tooth dislocation 25.15 16.60 5 23831 51 110565412
Intentional product use issue 25.09 16.60 11 23825 247895 110317568
Transaminases increased 24.75 16.60 47 23789 63343 110502120
Cytomegalovirus infection 24.60 16.60 43 23793 54401 110511062
Reticulin increased 24.49 16.60 4 23832 11 110565452
Jaundice 24.48 16.60 45 23791 59191 110506272
Concomitant disease progression 24.39 16.60 13 23823 3597 110561866
Iron overload 24.30 16.60 11 23825 2140 110563323
Conjunctival haemorrhage 24.08 16.60 16 23820 6617 110558846
Reticulocyte count increased 23.98 16.60 10 23826 1596 110563867
Hypotension 23.94 16.60 48 23788 523801 110041662
Drug intolerance 23.45 16.60 32 23804 406480 110158983
Folliculitis 23.35 16.60 4 23832 167649 110397814
Hepatic failure 23.26 16.60 48 23788 68691 110496772
Thrombotic microangiopathy 23.20 16.60 30 23806 29119 110536344
Transverse sinus thrombosis 23.09 16.60 8 23828 770 110564693
Hepatic infection 22.51 16.60 9 23827 1290 110564173
Biopsy bone marrow abnormal 22.30 16.60 7 23829 495 110564968
Autoimmune haemolytic anaemia 21.49 16.60 18 23818 10549 110554914
Head banging 21.45 16.60 7 23829 561 110564902
Oesophageal adenocarcinoma 21.14 16.60 8 23828 991 110564472
Anxiety 21.10 16.60 26 23810 345052 110220411
Hypoparathyroidism 21.09 16.60 9 23827 1521 110563942
Pulmonary artery thrombosis 20.69 16.60 9 23827 1593 110563870
Chronic myelomonocytic leukaemia 20.65 16.60 8 23828 1055 110564408
Reticulocytosis 20.63 16.60 7 23829 633 110564830
Embolism 20.08 16.60 21 23815 16268 110549195
Cushingoid 19.89 16.60 18 23818 11694 110553769
Hypercoagulation 19.76 16.60 11 23825 3315 110562148
Liver function test abnormal 19.74 16.60 45 23791 68905 110496558
Pneumonia 19.64 16.60 281 23555 876433 109689030
Sinusitis 19.60 16.60 21 23815 296667 110268796
Discomfort 19.50 16.60 11 23825 214696 110350767
Splenic infarction 19.47 16.60 12 23824 4362 110561101
SARS-CoV-2 test positive 19.40 16.60 21 23815 16914 110548549
Oral mucosa haematoma 19.37 16.60 4 23832 50 110565413
Cytogenetic analysis abnormal 19.28 16.60 8 23828 1261 110564202
Myocardial infarction 19.05 16.60 87 23749 191996 110373467
Haemolysis 18.99 16.60 20 23816 15619 110549844
Mesenteric vein thrombosis 18.80 16.60 9 23827 1986 110563477
Myeloproliferative neoplasm 18.50 16.60 8 23828 1397 110564066
Post transplant distal limb syndrome 18.42 16.60 7 23829 877 110564586
Subdural haematoma 18.06 16.60 30 23806 36424 110529039
Systemic lupus erythematosus 17.95 16.60 17 23819 254321 110311142
Leukaemia 17.81 16.60 14 23822 7504 110557959
Red blood cell count decreased 17.75 16.60 42 23794 65881 110499582
Hospitalisation 17.60 16.60 69 23767 142424 110423039
Platelet glycoprotein gene mutation 17.50 16.60 3 23833 12 110565451
Haemosiderosis 17.31 16.60 6 23830 578 110564885
Abdominal discomfort 17.21 16.60 37 23799 393821 110171642
Infection 17.08 16.60 135 23701 362065 110203398
Mantle cell lymphoma 17.07 16.60 8 23828 1684 110563779
Granulocytopenia 16.77 16.60 17 23819 12698 110552765

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B02BX05 BLOOD AND BLOOD FORMING ORGANS
ANTIHEMORRHAGICS
VITAMIN K AND OTHER HEMOSTATICS
Other systemic hemostatics
FDA MoA N0000175968 Thrombopoietin Receptor Agonists
FDA PE N0000175969 Increased Megakaryocyte Maturation
FDA PE N0000175970 Increased Platelet Production
FDA EPC N0000175973 Thrombopoietin Receptor Agonist
FDA MoA N0000190107 Organic Anion Transporting Polypeptide 1B1 Inhibitors
FDA MoA N0000190113 Breast Cancer Resistance Protein Inhibitors
FDA MoA N0000191272 UGT1A1 Inhibitors
FDA MoA N0000191273 UGT2B7 Inhibitors
FDA MoA N0000191274 UGT2B15 Inhibitors
FDA MoA N0000191275 UGT1A3 Inhibitors
FDA MoA N0000191276 UGT1A4 Inhibitors
FDA MoA N0000191277 UGT1A6 Inhibitors
FDA MoA N0000191278 UGT1A9 Inhibitors
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:62868 hepatoprotective agent
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:85012 thrombopoietin receptor agonist

Related Drugs by ATC class:

B02BX Other systemic hemostatics 10 drugs
avatrombopagcarbazochromeconcizumabemicizumabetamsylatefitusiranfostamatiniblusutrombopagmarstacimab-hncqromiplostim

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

DiseaseRelationSNOMED_IDDOID
Chronic idiopathic thrombocytopenic purpura indication 13172003
Aplastic anemia indication 306058006 DOID:12449
Thrombocytosis contraindication 6631009 DOID:2228
Hyperbilirubinemia contraindication 14783006 DOID:2741
Acute hepatitis contraindication 37871000
Hepatic vein thrombosis contraindication 38739001 DOID:11512
Leukopenia contraindication 84828003 DOID:615
Kidney disease contraindication 90708001 DOID:557
Bilateral cataracts contraindication 95722004
Myelodysplastic syndrome contraindication 109995007
Liver function tests abnormal contraindication 166603001
Acute hepatic failure contraindication 197270009
Disease of liver contraindication 235856003 DOID:409
Anemia contraindication 271737000 DOID:2355
Thromboembolic disorder contraindication 371039008
Predisposition to Thrombosis contraindication
Increased Reticulin Bone Marrow Deposition contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.16 acidic
pKa2 3.76 acidic
pKa3 10.67 acidic
pKa4 1.34 Basic
pKa5 0.59 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** PROMACTA NOVARTIS N022291 Nov. 16, 2012 DISCN TABLET ORAL 7547719 July 13, 2025 PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** PROMACTA NOVARTIS N022291 Nov. 16, 2012 DISCN TABLET ORAL 7547719 July 13, 2025 TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** PROMACTA NOVARTIS N022291 Nov. 16, 2012 DISCN TABLET ORAL 7547719 July 13, 2025 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 12.5MG ACID PROMACTA NOVARTIS N022291 Oct. 20, 2011 RX TABLET ORAL 7547719 July 13, 2025 COMBINATION WITH IMMUNOSUPPRESSIVE THERAPY FOR FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 12.5MG ACID PROMACTA NOVARTIS N022291 Oct. 20, 2011 RX TABLET ORAL 7547719 July 13, 2025 PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 12.5MG ACID PROMACTA NOVARTIS N022291 Oct. 20, 2011 RX TABLET ORAL 7547719 July 13, 2025 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID PROMACTA NOVARTIS N022291 Oct. 20, 2011 RX TABLET ORAL 7547719 July 13, 2025 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 25MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 7547719 July 13, 2025 COMBINATION WITH IMMUNOSUPPRESSIVE THERAPY FOR FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 25MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 7547719 July 13, 2025 PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 25MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 7547719 July 13, 2025 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 7547719 July 13, 2025 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 50MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 7547719 July 13, 2025 COMBINATION WITH IMMUNOSUPPRESSIVE THERAPY FOR FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 50MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 7547719 July 13, 2025 PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 50MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 7547719 July 13, 2025 TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 50MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 7547719 July 13, 2025 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 50MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 7547719 July 13, 2025 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 75MG ACID PROMACTA NOVARTIS N022291 Sept. 8, 2009 RX TABLET ORAL 7547719 July 13, 2025 COMBINATION WITH IMMUNOSUPPRESSIVE THERAPY FOR FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 75MG ACID PROMACTA NOVARTIS N022291 Sept. 8, 2009 RX TABLET ORAL 7547719 July 13, 2025 PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 75MG ACID PROMACTA NOVARTIS N022291 Sept. 8, 2009 RX TABLET ORAL 7547719 July 13, 2025 TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 75MG ACID PROMACTA NOVARTIS N022291 Sept. 8, 2009 RX TABLET ORAL 7547719 July 13, 2025 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 75MG ACID PROMACTA NOVARTIS N022291 Sept. 8, 2009 RX TABLET ORAL 7547719 July 13, 2025 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 12.5MG ACID/PACKET PROMACTA KIT NOVARTIS N207027 Sept. 27, 2018 RX FOR SUSPENSION ORAL 7547719 July 13, 2025 COMBINATION WITH IMMUNOSUPPRESSIVE THERAPY FOR FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 12.5MG ACID/PACKET PROMACTA KIT NOVARTIS N207027 Sept. 27, 2018 RX FOR SUSPENSION ORAL 7547719 July 13, 2025 PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 12.5MG ACID/PACKET PROMACTA KIT NOVARTIS N207027 Sept. 27, 2018 RX FOR SUSPENSION ORAL 7547719 July 13, 2025 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID/PACKET PROMACTA KIT NOVARTIS N207027 Sept. 27, 2018 RX FOR SUSPENSION ORAL 7547719 July 13, 2025 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 25MG ACID/PACKET PROMACTA KIT NOVARTIS N207027 Aug. 24, 2015 RX FOR SUSPENSION ORAL 7547719 July 13, 2025 COMBINATION WITH IMMUNOSUPPRESSIVE THERAPY FOR FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
EQ 25MG ACID/PACKET PROMACTA KIT NOVARTIS N207027 Aug. 24, 2015 RX FOR SUSPENSION ORAL 7547719 July 13, 2025 PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 25MG ACID/PACKET PROMACTA KIT NOVARTIS N207027 Aug. 24, 2015 RX FOR SUSPENSION ORAL 7547719 July 13, 2025 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID/PACKET PROMACTA KIT NOVARTIS N207027 Aug. 24, 2015 RX FOR SUSPENSION ORAL 7547719 July 13, 2025 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 12.5MG ACID PROMACTA NOVARTIS N022291 Oct. 20, 2011 RX TABLET ORAL 8052993 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID PROMACTA NOVARTIS N022291 Oct. 20, 2011 RX TABLET ORAL 8052994 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID PROMACTA NOVARTIS N022291 Oct. 20, 2011 RX TABLET ORAL 8062665 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID PROMACTA NOVARTIS N022291 Oct. 20, 2011 RX TABLET ORAL 8071129 Aug. 1, 2027 TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 12.5MG ACID PROMACTA NOVARTIS N022291 Oct. 20, 2011 RX TABLET ORAL 8071129 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID PROMACTA NOVARTIS N022291 Oct. 20, 2011 RX TABLET ORAL 8071129 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 12.5MG ACID PROMACTA NOVARTIS N022291 Oct. 20, 2011 RX TABLET ORAL 8828430 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 12.5MG ACID PROMACTA NOVARTIS N022291 Oct. 20, 2011 RX TABLET ORAL 8828430 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 25MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 8052993 Aug. 1, 2027 PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 25MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 8052993 Aug. 1, 2027 TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 25MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 8052993 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 8052993 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 25MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 8052994 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 8062665 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 8071129 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 8828430 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 25MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 8828430 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 50MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 8052993 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 50MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 8052994 Aug. 1, 2027 TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 50MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 8052994 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 50MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 8052994 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 50MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 8062665 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 50MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 8071129 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 50MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 8828430 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 50MG ACID PROMACTA NOVARTIS N022291 Nov. 20, 2008 RX TABLET ORAL 8828430 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 75MG ACID PROMACTA NOVARTIS N022291 Sept. 8, 2009 RX TABLET ORAL 8052993 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 75MG ACID PROMACTA NOVARTIS N022291 Sept. 8, 2009 RX TABLET ORAL 8052994 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 75MG ACID PROMACTA NOVARTIS N022291 Sept. 8, 2009 RX TABLET ORAL 8062665 Aug. 1, 2027 TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
EQ 75MG ACID PROMACTA NOVARTIS N022291 Sept. 8, 2009 RX TABLET ORAL 8062665 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 75MG ACID PROMACTA NOVARTIS N022291 Sept. 8, 2009 RX TABLET ORAL 8062665 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 75MG ACID PROMACTA NOVARTIS N022291 Sept. 8, 2009 RX TABLET ORAL 8071129 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 75MG ACID PROMACTA NOVARTIS N022291 Sept. 8, 2009 RX TABLET ORAL 8828430 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP)
EQ 75MG ACID PROMACTA NOVARTIS N022291 Sept. 8, 2009 RX TABLET ORAL 8828430 Aug. 1, 2027 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 18MG BASE ALVAIZ TEVA PHARMS INC N216774 Nov. 29, 2023 RX TABLET ORAL 11072586 Nov. 5, 2038 TREATMENT OF ADULT PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 18MG BASE ALVAIZ TEVA PHARMS INC N216774 Nov. 29, 2023 RX TABLET ORAL 11072586 Nov. 5, 2038 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH PERSISTENT OR CHRONIC IMMUNE THROMBOCYTOPENIA (ITP)
EQ 18MG BASE ALVAIZ TEVA PHARMS INC N216774 Nov. 29, 2023 RX TABLET ORAL 11072586 Nov. 5, 2038 TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 36MG BASE ALVAIZ TEVA PHARMS INC N216774 Nov. 29, 2023 RX TABLET ORAL 11072586 Nov. 5, 2038 TREATMENT OF ADULT PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 36MG BASE ALVAIZ TEVA PHARMS INC N216774 Nov. 29, 2023 RX TABLET ORAL 11072586 Nov. 5, 2038 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH PERSISTENT OR CHRONIC IMMUNE THROMBOCYTOPENIA (ITP)
EQ 36MG BASE ALVAIZ TEVA PHARMS INC N216774 Nov. 29, 2023 RX TABLET ORAL 11072586 Nov. 5, 2038 TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 54MG BASE ALVAIZ TEVA PHARMS INC N216774 Nov. 29, 2023 RX TABLET ORAL 11072586 Nov. 5, 2038 TREATMENT OF ADULT PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 54MG BASE ALVAIZ TEVA PHARMS INC N216774 Nov. 29, 2023 RX TABLET ORAL 11072586 Nov. 5, 2038 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH PERSISTENT OR CHRONIC IMMUNE THROMBOCYTOPENIA (ITP)
EQ 54MG BASE ALVAIZ TEVA PHARMS INC N216774 Nov. 29, 2023 RX TABLET ORAL 11072586 Nov. 5, 2038 TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
EQ 9MG BASE ALVAIZ TEVA PHARMS INC N216774 Nov. 29, 2023 RX TABLET ORAL 11072586 Nov. 5, 2038 TREATMENT OF ADULT PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
EQ 9MG BASE ALVAIZ TEVA PHARMS INC N216774 Nov. 29, 2023 RX TABLET ORAL 11072586 Nov. 5, 2038 TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH PERSISTENT OR CHRONIC IMMUNE THROMBOCYTOPENIA (ITP)
EQ 9MG BASE ALVAIZ TEVA PHARMS INC N216774 Nov. 29, 2023 RX TABLET ORAL 11072586 Nov. 5, 2038 TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Thrombopoietin receptor Membrane receptor AGONIST EC50 7.42 IUPHAR IUPHAR
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 6.16 CHEMBL
ATP-binding cassette sub-family G member 2 Transporter IC50 5.51 CHEMBL

External reference:

IDSource
D03978 KEGG_DRUG
4028105 VUID
N0000179799 NUI
496775-62-3 SECONDARY_CAS_RN
4028105 VANDF
C1831905 UMLSCUI
CHEMBL461101 ChEMBL_ID
CHEMBL3989691 ChEMBL_ID
DB06210 DRUGBANK_ID
C520809 MESH_SUPPLEMENTAL_RECORD_UI
6961 IUPHAR_LIGAND_ID
8655 INN_ID
S56D65XJ9G UNII
135449332 PUBCHEM_CID
2675185 RXNORM
26020 MMSL
394882 MMSL
42248 MMSL
d07357 MMSL
012912 NDDF
012913 NDDF
019622 NDDF
432005001 SNOMEDCT_US
434132009 SNOMEDCT_US
441995009 SNOMEDCT_US
CHEBI:760243 CHEBI
CHEMBL6068328 ChEMBL_ID
2336813-25-1 SECONDARY_CAS_RN
S56D65XJ9G INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Eltrombopag HUMAN PRESCRIPTION DRUG LABEL 1 0054-0962 TABLET 12.50 mg ORAL ANDA 30 sections
Eltrombopag HUMAN PRESCRIPTION DRUG LABEL 1 0054-0963 TABLET 25 mg ORAL ANDA 30 sections
Eltrombopag HUMAN PRESCRIPTION DRUG LABEL 1 0054-0964 TABLET 50 mg ORAL ANDA 30 sections
Eltrombopag HUMAN PRESCRIPTION DRUG LABEL 1 0054-0965 TABLET 75 mg ORAL ANDA 30 sections
PROMACTA HUMAN PRESCRIPTION DRUG LABEL 1 0078-0684 TABLET, FILM COATED 12.50 mg ORAL NDA 34 sections
PROMACTA HUMAN PRESCRIPTION DRUG LABEL 1 0078-0685 TABLET, FILM COATED 25 mg ORAL NDA 34 sections
PROMACTA HUMAN PRESCRIPTION DRUG LABEL 1 0078-0686 TABLET, FILM COATED 50 mg ORAL NDA 34 sections
PROMACTA HUMAN PRESCRIPTION DRUG LABEL 1 0078-0687 TABLET, FILM COATED 75 mg ORAL NDA 34 sections
PROMACTA HUMAN PRESCRIPTION DRUG LABEL 1 0078-0697 POWDER, FOR SUSPENSION 25 mg ORAL NDA 34 sections
PROMACTA HUMAN PRESCRIPTION DRUG LABEL 1 0078-0972 POWDER, FOR SUSPENSION 12.50 mg ORAL NDA 34 sections
ALVAIZ HUMAN PRESCRIPTION DRUG LABEL 1 0480-3273 TABLET, FILM COATED 9 mg ORAL NDA 30 sections
ALVAIZ HUMAN PRESCRIPTION DRUG LABEL 1 0480-3274 TABLET, FILM COATED 18 mg ORAL NDA 30 sections
ALVAIZ HUMAN PRESCRIPTION DRUG LABEL 1 0480-3275 TABLET, FILM COATED 36 mg ORAL NDA 30 sections
ALVAIZ HUMAN PRESCRIPTION DRUG LABEL 1 0480-3276 TABLET, FILM COATED 54 mg ORAL NDA 30 sections
Eltrombopag HUMAN PRESCRIPTION DRUG LABEL 1 31722-300 POWDER, FOR SUSPENSION 12.50 mg ORAL ANDA 26 sections
Eltrombopag HUMAN PRESCRIPTION DRUG LABEL 1 31722-301 POWDER, FOR SUSPENSION 25 mg ORAL ANDA 26 sections
ELTROMBOPAG HUMAN PRESCRIPTION DRUG LABEL 1 31722-841 TABLET, FILM COATED 12.50 mg ORAL ANDA 30 sections
ELTROMBOPAG HUMAN PRESCRIPTION DRUG LABEL 1 31722-842 TABLET, FILM COATED 25 mg ORAL ANDA 30 sections
ELTROMBOPAG HUMAN PRESCRIPTION DRUG LABEL 1 31722-843 TABLET, FILM COATED 50 mg ORAL ANDA 30 sections
ELTROMBOPAG HUMAN PRESCRIPTION DRUG LABEL 1 31722-844 TABLET, FILM COATED 75 mg ORAL ANDA 30 sections
Eltrombopag Olamine HUMAN PRESCRIPTION DRUG LABEL 1 42291-932 TABLET, FILM COATED 12.50 mg ORAL ANDA 29 sections
Eltrombopag Olamine HUMAN PRESCRIPTION DRUG LABEL 1 42291-933 TABLET, FILM COATED 25 mg ORAL ANDA 29 sections
Eltrombopag Olamine HUMAN PRESCRIPTION DRUG LABEL 1 42291-934 TABLET, FILM COATED 50 mg ORAL ANDA 29 sections
Eltrombopag Olamine HUMAN PRESCRIPTION DRUG LABEL 1 42291-935 TABLET, FILM COATED 75 mg ORAL ANDA 29 sections
eltrombopag HUMAN PRESCRIPTION DRUG LABEL 1 43598-151 TABLET, FILM COATED 12.50 mg ORAL ANDA 33 sections
eltrombopag HUMAN PRESCRIPTION DRUG LABEL 1 43598-730 TABLET, FILM COATED 25 mg ORAL ANDA 33 sections
eltrombopag HUMAN PRESCRIPTION DRUG LABEL 1 43598-731 TABLET, FILM COATED 50 mg ORAL ANDA 33 sections
eltrombopag HUMAN PRESCRIPTION DRUG LABEL 1 43598-732 TABLET, FILM COATED 75 mg ORAL ANDA 33 sections
Eltrombopag Olamine HUMAN PRESCRIPTION DRUG LABEL 1 60219-1414 TABLET, FILM COATED 75 mg ORAL ANDA 29 sections
Eltrombopag Olamine HUMAN PRESCRIPTION DRUG LABEL 1 60219-1415 TABLET, FILM COATED 50 mg ORAL ANDA 29 sections