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

FDA Adverse Event Reporting System (Female)

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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	1806.32	20.25	342	11924	3022	63473734
Platelet count decreased	1351.64	20.25	583	11683	115539	63361217
Therapeutic response decreased	1110.41	20.25	424	11842	61101	63415655
Thrombocytopenia	583.06	20.25	362	11904	150795	63325961
Thrombocytosis	475.14	20.25	127	12139	5691	63471065
Platelet count increased	300.20	20.25	117	12149	17594	63459162
Splenectomy	274.76	20.25	53	12213	515	63476241
Petechiae	272.10	20.25	102	12164	13795	63462961
Myelofibrosis	270.95	20.25	61	12205	1316	63475440
Biopsy bone marrow abnormal	235.58	20.25	42	12224	252	63476504

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FDA Adverse Event Reporting System (Male)

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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	1043.47	19.08	230	10766	2692	34943243
Therapeutic response decreased	821.51	19.08	318	10678	28995	34916940
Platelet count decreased	767.80	19.08	472	10524	119245	34826690
Drug ineffective	373.36	19.08	574	10422	456177	34489758
Bone marrow reticulin fibrosis	319.10	19.08	54	10942	118	34945817
Platelet count increased	271.91	19.08	105	10891	9421	34936514
Thrombocytosis	268.18	19.08	84	10912	4028	34941907
Thrombocytopenia	244.81	19.08	272	10724	155975	34789960
Myelodysplastic syndrome	218.64	19.08	111	10885	19097	34926838
Coombs positive haemolytic anaemia	195.11	19.08	48	10948	924	34945011

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FDA Adverse Event Reporting System (Geriatric)

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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	2127.58	19.05	423	16522	4439	79723004
Platelet count decreased	1429.88	19.05	733	16212	193931	79533512
Therapeutic response decreased	772.98	19.05	345	16600	66508	79660935
Thrombocytosis	669.00	19.05	184	16761	8342	79719101
Thrombocytopenia	514.56	19.05	435	16510	264824	79462619
Platelet count increased	359.13	19.05	146	16799	22260	79705183
Petechiae	333.00	19.05	135	16810	20430	79707013
Myelofibrosis	326.91	19.05	81	16864	2419	79725024
Bone marrow reticulin fibrosis	282.21	19.05	51	16894	299	79727144
Drug ineffective	233.00	19.05	623	16322	1080290	78647153

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	B02BX04	BLOOD AND BLOOD FORMING ORGANS ANTIHEMORRHAGICS VITAMIN K AND OTHER HEMOSTATICS Other systemic hemostatics
FDA EPC	N0000175973	Thrombopoietin Receptor Agonist
FDA MoA	N0000175968	Thrombopoietin Receptor Agonists
FDA PE	N0000175969	Increased Megakaryocyte Maturation
FDA PE	N0000175970	Increased Platelet Production

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

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Disease	Relation	SNOMED_ID	DOID
Chronic idiopathic thrombocytopenic purpura	indication	13172003
Aplastic anemia	indication	306058006	DOID:12449

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🐶 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:

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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

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External reference:

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ID	Source
012794	NDDF
147787	MMSL
25808	MMSL
4028106	VUID
4028106	VANDF
439122000	SNOMEDCT_US
441077008	SNOMEDCT_US
5329098	PUBCHEM_CID
6974	IUPHAR_LIGAND_ID
805452	RXNORM

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Pharmaceutical products:

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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

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