romiplostim 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
colony stimulating factors 4996 267639-76-9

Description:

MoleculeDescription

Synonyms:

  • romiplostim
  • nplate
  • AMG-531
  • AMG531
Romiplostim, a member of the TPO mimetic class, is an Fc-peptide fusion protein (peptibody) that activates intracellular transcriptional pathways leading to increased platelet production via the TPO receptor (also known as cMpl). The peptibody molecule contains two identical single-chain subunits, each consisting of human immunoglobulin IgG1 Fc domain, covalently linked at the C-terminus to a peptide containing two thrombopoietin receptor-binding domains. Romiplostim has no amino acid sequence homology to endogenous TPO. Romiplostim is produced by recombinant DNA technology in Escherichia coli.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
30 mcg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 21, 2011 PMDA Kyowa Hakko Kirin
Aug. 22, 2008 FDA AMGEN
Feb. 4, 2009 EMA

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 abnormal 1740.63 21.30 332 11322 2517 50590953
Platelet count decreased 1262.02 21.30 561 11093 100165 50493305
Therapeutic response decreased 1125.29 21.30 418 11236 46813 50546657
Thrombocytopenia 550.77 21.30 350 11304 127323 50466147
Thrombocytosis 462.82 21.30 125 11529 4871 50588599
Platelet count increased 292.03 21.30 114 11540 14426 50579044
Splenectomy 271.07 21.30 53 11601 458 50593012
Petechiae 261.54 21.30 101 11553 12411 50581059
Myelofibrosis 255.13 21.30 58 11596 1089 50592381
Drug ineffective 217.61 21.30 536 11118 818797 49774673
Biopsy bone marrow abnormal 212.19 21.30 39 11615 232 50593238
Haemorrhage 208.55 21.30 138 11516 53303 50540167
Bone marrow reticulin fibrosis 194.65 21.30 33 11621 112 50593358
Immune thrombocytopenia 161.09 21.30 65 11589 8952 50584518
Death 141.15 21.30 261 11393 325118 50268352
Myelodysplastic syndrome 131.78 21.30 66 11588 15066 50578404
Purpura 122.42 21.30 55 11599 9856 50583614
Deep vein thrombosis 107.82 21.30 107 11547 73197 50520273
Hospitalisation 95.91 21.30 97 11557 67840 50525630
Epistaxis 93.38 21.30 93 11561 63861 50529609
Contusion 90.51 21.30 120 11534 112063 50481407
Off label use 90.24 21.30 276 11378 474150 50119320
Chronic lymphocytic leukaemia 79.33 21.30 27 11627 2306 50591164
Mucosal haemorrhage 73.95 21.30 20 11634 780 50592690
Gingival bleeding 69.07 21.30 39 11615 11314 50582156
Vaginal haemorrhage 66.92 21.30 51 11603 24500 50568970
Therapy non-responder 58.06 21.30 65 11589 50957 50542513
Bone marrow disorder 52.64 21.30 19 11635 1929 50591541
Pulmonary embolism 52.09 21.30 88 11566 101616 50491854
Haematological malignancy 51.63 21.30 12 11642 249 50593221
Mouth haemorrhage 48.04 21.30 25 11629 6171 50587299
Ecchymosis 41.38 21.30 27 11627 10142 50583328
Melaena 40.90 21.30 40 11614 26824 50566646
Leukocytosis 40.85 21.30 37 11617 22542 50570928
Drug hypersensitivity 40.69 21.30 5 11649 251005 50342465
Headache 38.64 21.30 223 11431 506312 50087158
Haemorrhage intracranial 36.59 21.30 27 11627 12347 50581123
Acute myeloid leukaemia 36.06 21.30 29 11625 15045 50578425
Rheumatoid arthritis 35.50 21.30 3 11651 202547 50390923
Leukoerythroblastic anaemia 35.02 21.30 6 11648 22 50593448
Toxicity to various agents 35.01 21.30 4 11650 212495 50380975
Thrombosis 34.99 21.30 53 11601 55780 50537690
Rectal haemorrhage 33.76 21.30 43 11611 38515 50554955
Aplastic anaemia 32.69 21.30 21 11633 7682 50585788
White blood cell count increased 32.18 21.30 44 11610 42196 50551274
Cerebral venous thrombosis 31.73 21.30 13 11641 1858 50591612
Cerebral haemorrhage 31.68 21.30 35 11619 27017 50566453
Platelet disorder 30.79 21.30 12 11642 1505 50591965
Cerebral venous sinus thrombosis 29.69 21.30 12 11642 1656 50591814
Embolism arterial 29.50 21.30 10 11644 843 50592627
Joint swelling 29.27 21.30 10 11644 245276 50348194
Sudden hearing loss 27.24 21.30 10 11644 1065 50592405
Rash maculo-papular 27.02 21.30 32 11622 26609 50566861
Reticulin increased 26.74 21.30 4 11650 4 50593466
Portal vein thrombosis 26.43 21.30 12 11642 2200 50591270
Blood blister 26.34 21.30 11 11643 1649 50591821
Chronic myelomonocytic leukaemia 25.33 21.30 7 11647 296 50593174
Diarrhoea 25.27 21.30 62 11592 588414 50005056
Marrow hyperplasia 24.92 21.30 8 11646 569 50592901
Drug intolerance 24.34 21.30 10 11644 219094 50374376
Antibody test 23.72 21.30 4 11650 13 50593457
Bone pain 23.00 21.30 40 11614 47189 50546281
Gastrointestinal haemorrhage 22.31 21.30 51 11603 73270 50520200
Megaloblasts increased 22.13 21.30 3 11651 0 50593470
Nausea 22.01 21.30 86 11568 705312 49888158
Blood smear test abnormal 21.88 21.30 5 11649 96 50593374
Splenomegaly 21.87 21.30 18 11636 9642 50583828
Product use issue 21.85 21.30 4 11650 149471 50443999

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 abnormal 1004.31 20.52 219 10075 2175 29562058
Therapeutic response decreased 825.17 20.52 313 9981 24398 29539835
Platelet count decreased 736.32 20.52 454 9840 104218 29460015
Drug ineffective 374.57 20.52 537 9757 362633 29201600
Bone marrow reticulin fibrosis 307.47 20.52 53 10241 117 29564116
Thrombocytosis 259.67 20.52 80 10214 3273 29560960
Platelet count increased 255.89 20.52 100 10194 8363 29555870
Thrombocytopenia 222.26 20.52 253 10041 134570 29429663
Myelodysplastic syndrome 204.57 20.52 107 10187 17687 29546546
Myelofibrosis 157.31 20.52 45 10249 1417 29562816
Haematological malignancy 148.03 20.52 32 10262 301 29563932
Splenectomy 147.23 20.52 33 10261 372 29563861
Immune thrombocytopenia 134.26 20.52 62 10232 7815 29556418
Petechiae 132.32 20.52 63 10231 8508 29555725
Hospitalisation 130.24 20.52 116 10178 45872 29518361
Coombs positive haemolytic anaemia 126.93 20.52 33 10261 719 29563514
Biopsy bone marrow abnormal 124.60 20.52 27 10267 257 29563976
Lymphadenitis 102.17 20.52 33 10261 1574 29562659
Death 96.97 20.52 299 9995 341785 29222448
Therapeutic product effect decreased 88.73 20.52 77 10217 29374 29534859
Chronic lymphocytic leukaemia 82.54 20.52 35 10259 3598 29560635
Deep vein thrombosis 79.73 20.52 99 10195 57300 29506933
Haemorrhage 77.97 20.52 87 10207 44985 29519248
Haemolysis 77.50 20.52 41 10253 6915 29557318
Acute myeloid leukaemia 70.60 20.52 53 10241 16460 29547773
Off label use 66.39 20.52 242 10052 300558 29263675
Migraine 57.86 20.52 42 10252 12388 29551845
Epistaxis 57.53 20.52 80 10214 51624 29512609
Gingival bleeding 52.66 20.52 31 10263 6422 29557811
Investigation 51.91 20.52 17 10277 847 29563386
Drug interaction 48.27 20.52 6 10288 197379 29366854
Embolism arterial 47.47 20.52 14 10280 491 29563742
Contusion 46.97 20.52 56 10238 31039 29533194
Toxicity to various agents 45.74 20.52 4 10290 173657 29390576
Ecchymosis 43.09 20.52 27 10267 6253 29557980
Therapy non-responder 42.36 20.52 53 10241 30858 29533375
Cellulitis gangrenous 40.10 20.52 10 10284 183 29564050
Pulmonary embolism 39.27 20.52 84 10210 76450 29487783
Bone marrow disorder 38.77 20.52 16 10278 1536 29562697
Evans syndrome 37.46 20.52 10 10284 242 29563991
Platelet disorder 37.38 20.52 15 10279 1340 29562893
Mouth haemorrhage 33.93 20.52 21 10273 4759 29559474
Diarrhoea 30.46 20.52 43 10251 332655 29231578
Thrombosis 30.29 20.52 54 10240 42991 29521242
Mesenteric vascular insufficiency 28.95 20.52 7 10287 112 29564121
Cerebrovascular accident 28.12 20.52 74 10220 76837 29487396
Marrow hyperplasia 27.44 20.52 11 10283 980 29563253
Embolism 26.97 20.52 21 10273 6875 29557358
Lymphoma 26.20 20.52 24 10270 9804 29554429
Non-Hodgkin's lymphoma 26.17 20.52 12 10282 1485 29562748
Therapeutic response delayed 23.59 20.52 8 10286 444 29563789
Vomiting 23.02 20.52 24 10270 212236 29351997
Myeloproliferative neoplasm 22.80 20.52 8 10286 492 29563741
Leukocytosis 22.42 20.52 32 10262 21110 29543123
Protein-losing gastroenteropathy 22.38 20.52 7 10287 300 29563933
Multimorbidity 21.99 20.52 8 10286 547 29563686
Completed suicide 21.41 20.52 3 10291 90243 29473990
White blood cell count increased 21.35 20.52 43 10251 37473 29526760
Bone pain 21.16 20.52 29 10265 18423 29545810
Reticulin increased 20.89 20.52 3 10291 0 29564233

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 abnormal 2057.56 18.55 410 15483 3702 64479137
Platelet count decreased 1338.80 18.55 701 15192 167010 64315829
Therapeutic response decreased 789.71 18.55 340 15553 51848 64430991
Thrombocytosis 655.41 18.55 180 15713 6976 64475863
Thrombocytopenia 473.71 18.55 411 15482 223390 64259449
Platelet count increased 339.74 18.55 139 15754 18557 64464282
Petechiae 319.86 18.55 133 15760 18493 64464346
Myelofibrosis 315.55 18.55 79 15814 2114 64480725
Bone marrow reticulin fibrosis 286.03 18.55 51 15842 229 64482610
Biopsy bone marrow abnormal 208.84 18.55 42 15851 394 64482445
Drug ineffective 205.20 18.55 557 15336 839690 63643149
Splenectomy 194.35 18.55 43 15850 660 64482179
Haemorrhage 192.30 18.55 158 15735 79193 64403646
Myelodysplastic syndrome 186.82 18.55 104 15789 27475 64455364
Off label use 177.07 18.55 442 15451 632364 63850475
Immune thrombocytopenia 166.46 18.55 79 15814 14987 64467852
Deep vein thrombosis 136.25 18.55 148 15745 105034 64377805
Coombs positive haemolytic anaemia 133.15 18.55 33 15860 845 64481994
Hospitalisation 128.68 18.55 123 15770 75084 64407755
Epistaxis 126.95 18.55 138 15755 97993 64384846
Gingival bleeding 120.05 18.55 63 15830 14791 64468048
Purpura 111.23 18.55 63 15830 17183 64465656
Contusion 108.58 18.55 137 15756 113828 64369011
Death 99.41 18.55 302 15591 482403 64000436
Lymphadenitis 85.65 18.55 33 15860 3752 64479087
Haemolysis 81.25 18.55 44 15849 10995 64471844
Therapeutic product effect decreased 80.08 18.55 119 15774 115232 64367607
Therapy non-responder 78.82 18.55 89 15804 65810 64417029
Haematological malignancy 74.73 18.55 19 15874 541 64482298
Pulmonary embolism 71.75 18.55 129 15764 146227 64336612
Mucosal haemorrhage 66.68 18.55 24 15869 2257 64480582
Toxicity to various agents 64.94 18.55 7 15886 363506 64119333
Mouth haemorrhage 63.65 18.55 36 15857 9783 64473056
Vaginal haemorrhage 63.10 18.55 46 15847 19298 64463541
Ecchymosis 59.02 18.55 39 15854 13983 64468856
Platelet disorder 55.56 18.55 21 15872 2266 64480573
Investigation 52.26 18.55 20 15873 2232 64480607
Drug interaction 51.36 18.55 13 15880 362070 64120769
Acute myeloid leukaemia 50.91 18.55 47 15846 27416 64455423
Chronic lymphocytic leukaemia 48.78 18.55 23 15870 4292 64478547
White blood cell count increased 47.06 18.55 69 15824 65945 64416894
Marrow hyperplasia 45.92 18.55 16 15877 1368 64481471
Leukocytosis 45.15 18.55 51 15842 37689 64445150
Headache 44.17 18.55 251 15642 529216 63953623
Neutralising antibodies positive 40.31 18.55 10 15883 257 64482582
Cellulitis gangrenous 39.84 18.55 10 15883 270 64482569
Leukoerythroblastic anaemia 39.22 18.55 6 15887 7 64482832
Reticulin increased 38.77 18.55 6 15887 8 64482831
Blood blister 36.09 18.55 16 15877 2592 64480247
Bone pain 35.76 18.55 51 15842 47521 64435318
Diarrhoea 33.57 18.55 81 15812 722623 63760216
Migraine 32.93 18.55 57 15836 62620 64420219
Drug hypersensitivity 32.82 18.55 9 15884 237806 64245033
Cerebral haemorrhage 31.59 18.55 50 15843 51040 64431799
Melaena 31.19 18.55 51 15842 53497 64429342
Cerebrovascular accident 30.90 18.55 89 15804 137494 64345345
Cerebral venous thrombosis 30.67 18.55 14 15879 2427 64480412
Mesenteric vascular insufficiency 29.98 18.55 7 15886 138 64482701
Dyspnoea 29.23 18.55 86 15807 718588 63764251
Bone marrow disorder 28.72 18.55 14 15879 2811 64480028
Condition aggravated 27.24 18.55 31 15862 372395 64110444
Evans syndrome 27.10 18.55 8 15885 401 64482438
Vomiting 26.97 18.55 60 15833 551057 63931782
Joint swelling 26.44 18.55 10 15883 215372 64267467
Haemorrhage intracranial 26.41 18.55 31 15862 23853 64458986
Intercepted medication error 26.10 18.55 9 15884 746 64482093
Rectal haemorrhage 25.90 18.55 51 15842 61766 64421073
Thrombosis 25.73 18.55 55 15838 70587 64412252
Anti-platelet antibody positive 25.43 18.55 7 15886 272 64482567
Acute kidney injury 25.33 18.55 45 15848 449195 64033644
Sudden hearing loss 25.31 18.55 11 15882 1699 64481140
Red blood cell abnormality 24.98 18.55 8 15885 527 64482312
Product use issue 24.48 18.55 4 15889 151711 64331128
Cerebral venous sinus thrombosis 24.45 18.55 11 15882 1844 64480995
Antibody test 23.95 18.55 4 15889 11 64482828
Portal vein thrombosis 23.75 18.55 15 15878 4976 64477863
Gastrointestinal haemorrhage 23.59 18.55 79 15814 132233 64350606
Hypotension 23.48 18.55 36 15857 380938 64101901
Mucocutaneous haemorrhage 23.39 18.55 6 15887 177 64482662
Splenomegaly 22.73 18.55 25 15868 17936 64464903
Upper respiratory tract inflammation 22.20 18.55 13 15880 3769 64479070
Peripheral swelling 22.10 18.55 12 15881 209141 64273698
Megaloblasts increased 21.93 18.55 3 15890 0 64482839
Megakaryocytes increased 21.85 18.55 5 15888 90 64482749
Megakaryocytes abnormal 21.79 18.55 5 15888 91 64482748
Neutralising antibodies 21.18 18.55 4 15889 26 64482813
Therapeutic response delayed 21.07 18.55 8 15885 874 64481965
Myeloproliferative neoplasm 21.00 18.55 8 15885 881 64481958
Antiphospholipid syndrome 19.65 18.55 9 15884 1573 64481266
Neoplasm malignant 19.34 18.55 27 15866 24661 64458178
Product preparation error 18.97 18.55 12 15881 3993 64478846

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B02BX04 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

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Chronic idiopathic thrombocytopenic purpura indication 13172003
Aplastic anemia indication 306058006 DOID:12449




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Thrombopoietin receptor Membrane receptor AGONIST DRUG LABEL DRUG LABEL

External reference:

IDSource
D08990 KEGG_DRUG
4028106 VUID
N0000177934 NUI
4028106 VANDF
CHEMBL1201832 ChEMBL_ID
C488777 MESH_SUPPLEMENTAL_RECORD_UI
6974 IUPHAR_LIGAND_ID
8587 INN_ID
DB05332 DRUGBANK_ID
GN5XU2DXKV UNII
135449332 PUBCHEM_CID
805452 RXNORM
147787 MMSL
25808 MMSL
d07320 MMSL
439122000 SNOMEDCT_US
441077008 SNOMEDCT_US
C2364481 UMLSCUI
012794 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Nplate HUMAN PRESCRIPTION DRUG LABEL 1 55513-221 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 250 ug SUBCUTANEOUS BLA 28 sections
Nplate HUMAN PRESCRIPTION DRUG LABEL 1 55513-221 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 250 ug SUBCUTANEOUS BLA 28 sections
Nplate HUMAN PRESCRIPTION DRUG LABEL 1 55513-222 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 ug SUBCUTANEOUS BLA 28 sections
Nplate HUMAN PRESCRIPTION DRUG LABEL 1 55513-222 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 ug SUBCUTANEOUS BLA 28 sections
Nplate HUMAN PRESCRIPTION DRUG LABEL 1 55513-223 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 125 ug SUBCUTANEOUS BLA 28 sections
Nplate HUMAN PRESCRIPTION DRUG LABEL 1 55513-223 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 125 ug SUBCUTANEOUS BLA 28 sections