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

Stem definition	Drug id	CAS RN
colony stimulating factors	4996	267639-76-9

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
30	mcg	P

ADMET properties:

None

Approvals:

Date	Agency	Company
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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Platelet count abnormal	1767.71	20.39	336	11606	2737	56277388
Platelet count decreased	1332.18	20.39	578	11364	105805	56174320
Therapeutic response decreased	1124.45	20.39	421	11521	52337	56227788
Thrombocytopenia	627.94	20.39	378	11564	135846	56144279
Thrombocytosis	468.93	20.39	126	11816	5236	56274889
Platelet count increased	291.22	20.39	114	11828	15784	56264341
Splenectomy	275.41	20.39	53	11889	458	56279667
Petechiae	265.54	20.39	101	11841	12938	56267187
Myelofibrosis	256.04	20.39	59	11883	1285	56278840
Biopsy bone marrow abnormal	227.74	20.39	41	11901	235	56279890
Drug ineffective	221.87	20.39	551	11391	918438	55361687
Immune thrombocytopenia	215.75	20.39	80	11862	9545	56270580
Haemorrhage	214.55	20.39	139	11803	56258	56223867
Bone marrow reticulin fibrosis	197.35	20.39	33	11909	112	56280013
Death	154.05	20.39	266	11676	341160	55938965
Myelodysplastic syndrome	143.76	20.39	70	11872	16336	56263789
Purpura	127.63	20.39	56	11886	10306	56269819
Deep vein thrombosis	120.37	20.39	112	11830	76865	56203260
Epistaxis	101.84	20.39	96	11846	66927	56213198
Hospitalisation	96.36	20.39	98	11844	74902	56205223
Off label use	89.13	20.39	289	11653	555891	55724234
Contusion	85.52	20.39	120	11822	128310	56151815
Mucosal haemorrhage	75.56	20.39	21	11921	987	56279138
Chronic lymphocytic leukaemia	74.96	20.39	27	11915	2961	56277164
Gingival bleeding	71.07	20.39	39	11903	11627	56268498
Vaginal haemorrhage	68.61	20.39	51	11891	25622	56254503
Rheumatoid arthritis	68.53	20.39	3	11939	382601	55897524
Therapy non-responder	59.23	20.39	69	11873	61286	56218839
Pulmonary embolism	54.04	20.39	88	11854	107036	56173089
Bone marrow disorder	53.00	20.39	19	11923	2055	56278070
Aplastic anaemia	52.05	20.39	29	11913	8899	56271226
Mouth haemorrhage	49.20	20.39	25	11917	6376	56273749
Haematological malignancy	48.80	20.39	12	11930	347	56279778
Ecchymosis	45.49	20.39	28	11914	10328	56269797
Leukocytosis	43.81	20.39	38	11904	23753	56256372
Melaena	41.93	20.39	40	11902	28250	56251875
Drug hypersensitivity	41.22	20.39	5	11937	275200	56004925
Haemorrhage intracranial	40.16	20.39	28	11914	12727	56267398
Acute myeloid leukaemia	39.37	20.39	31	11911	16941	56263184
Headache	36.87	20.39	223	11719	558821	55721304
Thrombosis	35.79	20.39	53	11889	59374	56220751
Leukoerythroblastic anaemia	35.51	20.39	6	11936	22	56280103
White blood cell count increased	34.56	20.39	45	11897	44714	56235411
Cerebral haemorrhage	34.20	20.39	36	11906	28570	56251555
Rectal haemorrhage	34.08	20.39	43	11899	41424	56238701
Toxicity to various agents	33.81	20.39	4	11938	224560	56055565
Joint swelling	33.43	20.39	10	11932	289790	55990335
Infusion related reaction	33.32	20.39	3	11939	208928	56071197
Cerebral venous thrombosis	32.48	20.39	13	11929	1900	56278225
Platelet disorder	30.42	20.39	12	11930	1688	56278437
Embolism arterial	30.01	20.39	10	11932	869	56279256
Cerebral venous sinus thrombosis	29.90	20.39	12	11930	1766	56278359
Drug intolerance	29.01	20.39	10	11932	264808	56015317
Reticulin increased	27.06	20.39	4	11938	4	56280121
Rash maculo-papular	27.03	20.39	32	11910	28875	56251250
Sudden hearing loss	26.66	20.39	10	11932	1228	56278897
Blood blister	26.40	20.39	11	11931	1781	56278344
Product use issue	26.36	20.39	4	11938	186037	56094088
Portal vein thrombosis	26.32	20.39	12	11930	2411	56277714
Gastrointestinal haemorrhage	26.28	20.39	53	11889	75898	56204227
Chronic myelomonocytic leukaemia	25.20	20.39	7	11935	328	56279797
Marrow hyperplasia	24.95	20.39	8	11934	616	56279509
Abdominal discomfort	24.81	20.39	14	11928	277260	56002865
Arthropathy	24.80	20.39	6	11936	200269	56079856
Diarrhoea	24.45	20.39	63	11879	638444	55641681
Antibody test	24.05	20.39	4	11938	13	56280112
Bone pain	23.63	20.39	40	11902	50145	56229980
Swelling	23.09	20.39	11	11931	239760	56040365
Mucocutaneous haemorrhage	22.49	20.39	5	11937	92	56280033
Megaloblasts increased	22.38	20.39	3	11939	0	56280125
Splenomegaly	22.36	20.39	18	11924	10150	56269975
Peripheral swelling	22.25	20.39	11	11931	234715	56045410
Blood smear test abnormal	22.09	20.39	5	11937	100	56280025
Pain	22.04	20.39	70	11872	663114	55617011
Cerebrovascular accident	21.88	20.39	58	11884	99212	56180913
Rash erythematous	20.70	20.39	32	11910	37189	56242936
Embolism	20.50	20.39	15	11927	7349	56272776

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Platelet count abnormal	1023.76	20.63	223	10235	2336	31684550
Therapeutic response decreased	820.00	20.63	313	10145	26196	31660690
Platelet count decreased	754.15	20.63	461	9997	109974	31576912
Drug ineffective	372.92	20.63	545	9913	395028	31291858
Bone marrow reticulin fibrosis	310.30	20.63	53	10405	117	31686769
Platelet count increased	263.10	20.63	102	10356	8814	31678072
Thrombocytosis	259.83	20.63	81	10377	3642	31683244
Thrombocytopenia	250.98	20.63	270	10188	142477	31544409
Myelodysplastic syndrome	219.19	20.63	113	10345	19138	31667748
Immune thrombocytopenia	177.84	20.63	76	10382	8422	31678464
Myelofibrosis	157.16	20.63	46	10412	1662	31685224
Splenectomy	148.51	20.63	33	10425	378	31686508
Haematological malignancy	139.09	20.63	32	10426	433	31686453
Petechiae	134.49	20.63	63	10395	8657	31678229
Hospitalisation	127.61	20.63	116	10342	49691	31637195
Coombs positive haemolytic anaemia	126.66	20.63	33	10425	767	31686119
Biopsy bone marrow abnormal	123.60	20.63	27	10431	284	31686602
Lymphadenitis	101.89	20.63	33	10425	1677	31685209
Death	100.89	20.63	303	10155	360266	31326620
Therapeutic product effect decreased	87.56	20.63	77	10381	31545	31655341
Haemorrhage	81.76	20.63	89	10369	47245	31639641
Deep vein thrombosis	81.10	20.63	100	10358	60636	31626250
Haemolysis	81.01	20.63	42	10416	7174	31679712
Chronic lymphocytic leukaemia	74.87	20.63	35	10423	4781	31682105
Acute myeloid leukaemia	69.50	20.63	54	10404	18618	31668268
Off label use	62.12	20.63	252	10206	347022	31339864
Epistaxis	58.49	20.63	80	10378	53627	31633259
Migraine	54.92	20.63	42	10416	14138	31672748
Gingival bleeding	53.54	20.63	31	10427	6570	31680316
Investigation	52.76	20.63	17	10441	849	31686037
Drug interaction	48.36	20.63	6	10452	208537	31478349
Embolism arterial	46.81	20.63	14	10444	545	31686341
Contusion	46.66	20.63	56	10402	32972	31653914
Toxicity to various agents	45.20	20.63	4	10454	181483	31505403
Ecchymosis	43.75	20.63	27	10431	6423	31680463
Therapy non-responder	42.41	20.63	54	10404	33757	31653129
Cellulitis gangrenous	40.63	20.63	10	10448	183	31686703
Pulmonary embolism	39.78	20.63	85	10373	81561	31605325
Bone marrow disorder	38.78	20.63	16	10442	1620	31685266
Evans syndrome	37.16	20.63	10	10448	264	31686622
Platelet disorder	36.80	20.63	15	10443	1472	31685414
Mouth haemorrhage	34.04	20.63	21	10437	4991	31681895
Marrow hyperplasia	31.04	20.63	12	10446	1025	31685861
Thrombosis	30.51	20.63	54	10404	45097	31641789
Diarrhoea	29.77	20.63	44	10414	352365	31334521
Mesenteric vascular insufficiency	29.33	20.63	7	10451	112	31686774
Cerebrovascular accident	29.10	20.63	74	10384	79410	31607476
Embolism	27.02	20.63	21	10437	7232	31679654
Lymphoma	27.01	20.63	25	10433	10918	31675968
Myeloproliferative neoplasm	26.55	20.63	9	10449	527	31686359
Non-Hodgkin's lymphoma	26.20	20.63	12	10446	1563	31685323
Bone pain	22.83	20.63	30	10428	19321	31667565
Therapeutic response delayed	22.78	20.63	8	10450	521	31686365
Leukocytosis	22.63	20.63	32	10426	22082	31664804
Protein-losing gastroenteropathy	21.95	20.63	7	10451	338	31686548
Vomiting	21.92	20.63	25	10433	223948	31462938
White blood cell count increased	21.79	20.63	43	10415	38957	31647929
Thrombocytopenia neonatal	21.28	20.63	7	10451	373	31686513
Reticulin increased	21.05	20.63	3	10455	0	31686886

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Platelet count abnormal	2088.62	19.20	415	15860	3990	70908179
Platelet count decreased	1406.28	19.20	722	15553	177500	70734669
Therapeutic response decreased	779.11	19.20	341	15934	58112	70854057
Thrombocytosis	657.72	19.20	181	16094	7603	70904566
Thrombocytopenia	552.43	19.20	448	15827	238662	70673507
Platelet count increased	345.25	19.20	141	16134	20132	70892037
Petechiae	325.30	19.20	133	16142	19039	70893130
Myelofibrosis	314.94	19.20	80	16195	2447	70909722
Bone marrow reticulin fibrosis	289.66	19.20	51	16224	229	70911940
Immune thrombocytopenia	245.73	19.20	104	16171	16220	70895949
Biopsy bone marrow abnormal	221.13	19.20	44	16231	421	70911748
Drug ineffective	208.64	19.20	575	15700	939177	69972992
Myelodysplastic syndrome	205.59	19.20	111	16164	29674	70882495
Haemorrhage	200.95	19.20	161	16114	83654	70828515
Splenectomy	196.86	19.20	43	16232	669	70911500
Off label use	168.65	19.20	459	15816	742601	70169568
Deep vein thrombosis	147.24	19.20	153	16122	110889	70801280
Epistaxis	135.32	19.20	141	16134	102486	70809683
Coombs positive haemolytic anaemia	133.50	19.20	33	16242	900	70911269
Hospitalisation	126.36	19.20	123	16152	82445	70829724
Gingival bleeding	122.79	19.20	63	16212	15169	70897000
Purpura	115.72	19.20	64	16211	17911	70894258
Death	110.16	19.20	310	15965	509751	70402418
Contusion	103.68	19.20	137	16138	127899	70784270
Lymphadenitis	85.24	19.20	33	16242	4084	70908085
Haemolysis	85.14	19.20	45	16230	11506	70900663
Therapy non-responder	79.38	19.20	93	16182	76822	70835347
Pulmonary embolism	73.81	19.20	130	16145	155737	70756432
Haematological malignancy	69.42	19.20	19	16256	778	70911391
Therapeutic product effect decreased	67.34	19.20	119	16156	142899	70769270
Mucosal haemorrhage	67.07	19.20	24	16251	2385	70909784
Mouth haemorrhage	64.67	19.20	36	16239	10195	70901974
Vaginal haemorrhage	63.95	19.20	46	16229	20306	70891863
Toxicity to various agents	63.20	19.20	7	16268	382165	70530004
Ecchymosis	60.78	19.20	39	16236	14293	70897876
Platelet disorder	54.46	19.20	21	16254	2570	70909599
Investigation	53.48	19.20	20	16255	2251	70909918
Acute myeloid leukaemia	52.81	19.20	49	16226	30891	70881278
Marrow hyperplasia	50.00	19.20	17	16258	1452	70910717
Drug interaction	49.91	19.20	13	16262	381428	70530741
White blood cell count increased	48.05	19.20	69	16206	69504	70842665
Leukocytosis	46.05	19.20	51	16224	39617	70872552
Chronic lymphocytic leukaemia	43.90	19.20	23	16252	5775	70906394
Headache	41.69	19.20	251	16024	580154	70332015
Cellulitis gangrenous	40.44	19.20	10	16265	273	70911896
Neutralising antibodies positive	40.37	19.20	10	16265	275	70911894
Leukoerythroblastic anaemia	39.64	19.20	6	16269	7	70912162
Reticulin increased	39.20	19.20	6	16269	8	70912161
Bone pain	37.45	19.20	52	16223	50770	70861399
Blood blister	36.47	19.20	16	16259	2715	70909454
Drug hypersensitivity	34.20	19.20	9	16266	262450	70649719
Cerebral haemorrhage	33.69	19.20	51	16224	53813	70858356
Mucocutaneous haemorrhage	33.50	19.20	8	16267	188	70911981
Diarrhoea	32.90	19.20	83	16192	783258	70128911
Cerebrovascular accident	32.53	19.20	89	16186	143381	70768788
Melaena	31.96	19.20	51	16224	56304	70855865
Cerebral venous thrombosis	31.23	19.20	14	16261	2501	70909668
Haemorrhage intracranial	30.74	19.20	33	16242	24744	70887425
Joint swelling	30.58	19.20	10	16265	253201	70658968
Mesenteric vascular insufficiency	30.34	19.20	7	16268	141	70912028
Migraine	30.03	19.20	57	16218	72181	70839988
Condition aggravated	29.29	19.20	33	16242	427602	70484567
Dyspnoea	29.02	19.20	86	16189	769974	70142195
Gastrointestinal haemorrhage	28.95	19.20	83	16192	137325	70774844
Bone marrow disorder	28.94	19.20	14	16261	2971	70909198
Product use issue	27.99	19.20	4	16271	179933	70732236
Aplastic anaemia	27.61	19.20	26	16249	16690	70895479
Evans syndrome	27.19	19.20	8	16267	426	70911743
Vomiting	26.32	19.20	61	16214	593050	70319119
Rectal haemorrhage	26.20	19.20	51	16224	65780	70846389
Thrombosis	25.95	19.20	55	16220	75350	70836819
Anti-platelet antibody positive	25.83	19.20	7	16268	276	70911893
Intercepted medication error	25.41	19.20	9	16266	868	70911301
Sudden hearing loss	25.28	19.20	11	16264	1830	70910339
Myeloproliferative neoplasm	24.87	19.20	9	16266	923	70911246
Red blood cell abnormality	24.78	19.20	8	16267	581	70911588
Acute kidney injury	24.26	19.20	45	16230	474579	70437590
Cerebral venous sinus thrombosis	24.25	19.20	11	16264	2020	70910149
Antibody test	24.24	19.20	4	16271	11	70912158
Peripheral swelling	24.23	19.20	12	16263	236551	70675618
Portal vein thrombosis	23.75	19.20	15	16260	5347	70906822
Product preparation error	23.53	19.20	14	16261	4488	70907681
Splenomegaly	23.18	19.20	25	16250	18845	70893324
Hypotension	22.80	19.20	36	16239	404345	70507824
Upper respiratory tract inflammation	22.56	19.20	13	16262	3929	70908240
Drug intolerance	22.29	19.20	12	16263	225675	70686494
Megaloblasts increased	22.14	19.20	3	16272	0	70912169
Megakaryocytes abnormal	21.94	19.20	5	16270	95	70912074
Megakaryocytes increased	21.80	19.20	5	16270	98	70912071
Neutralising antibodies	21.47	19.20	4	16271	26	70912143
Therapeutic response delayed	20.64	19.20	8	16267	992	70911177
Drug effective for unapproved indication	20.61	19.20	13	16262	4622	70907547
Antiphospholipid syndrome	19.62	19.20	9	16266	1696	70910473
Chronic myeloid leukaemia	19.23	19.20	12	16263	4189	70907980

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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 | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Thrombopoietin receptor	Membrane receptor	P40238	TPOR_HUMAN	AGONIST				DRUG LABEL	DRUG LABEL

External reference:

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

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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	55513-221	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	55513-222	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
Nplate	HUMAN PRESCRIPTION DRUG LABEL	1	55513-223	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	125 ug	SUBCUTANEOUS	BLA	28 sections