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Romiplostim

Generic Name
Romiplostim
Brand Names
Nplate
Drug Type
Biotech
CAS Number
267639-76-9
Unique Ingredient Identifier
GN5XU2DXKV

Overview

Romiplostim is a thrombopoiesis stimulating dimer Fc-peptide fusion protein (peptibody) to increase platelet production through activation of the thrombopoietin receptor. The peptibody molecule has two identical single-chain subunits, each one is made up of 269 amino acid residues. Each subunit consists of an IgG1 Fc carrier domain that is covalently attached to a polypeptide sequence that contains two binding domains to interact with thrombopoietin receptor c-Mpl. Each domain consists of 14 amino acids. Interestingly, romiplostim's amino acid sequence is not similar to that of endogenous thrombopoietin. Romiplostim is produced by recombinant DNA technology in Escherichia coli. FDA approved on August 22, 2008.

Background

Romiplostim is a thrombopoiesis stimulating dimer Fc-peptide fusion protein (peptibody) to increase platelet production through activation of the thrombopoietin receptor. The peptibody molecule has two identical single-chain subunits, each one is made up of 269 amino acid residues. Each subunit consists of an IgG1 Fc carrier domain that is covalently attached to a polypeptide sequence that contains two binding domains to interact with thrombopoietin receptor c-Mpl. Each domain consists of 14 amino acids. Interestingly, romiplostim's amino acid sequence is not similar to that of endogenous thrombopoietin. Romiplostim is produced by recombinant DNA technology in Escherichia coli. FDA approved on August 22, 2008.

Indication

Treatment of chronic immune thrombocytopenic purpura.

Associated Conditions

  • Chronic immune thrombocytopenia
  • Refractory immune thrombocytopenia

FDA Approved Products

Nplate
Manufacturer:Amgen Inc
Route:SUBCUTANEOUS
Strength:250 ug in 0.5 mL
Approved: 2022/02/17
NDC:55513-221
Nplate
Manufacturer:Amgen Inc
Route:SUBCUTANEOUS
Strength:125 ug in 0.25 mL
Approved: 2022/02/17
NDC:55513-223
Nplate
Manufacturer:Amgen Inc
Route:SUBCUTANEOUS
Strength:500 ug in 1 mL
Approved: 2022/02/17
NDC:55513-222

Singapore Approved Products

ROMIPLATE POWDER FOR SOLUTION FOR INJECTION 250 μg/vial
Manufacturer:Patheon Italia S.p.A Monza Operations, Kyowa Kirin Co., Ltd. Takasaki-Plant
Form:INJECTION, POWDER, FOR SOLUTION
Strength:250 μg/vial (deliverable amount)
Online:Yes
Approved: 2014/12/03
Approval:SIN14688P

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