Romiplostim

Therapeutic Romiplostim fusion protein from the original Nplate® commercial drug

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Antigen
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TPO receptor (cMpl)
Peptibody
Nplate®
0,5 mg/mL
0,02 mg
2-8°C / -80°C
05/2025
639,00 
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NPlate® / Romiplostim Reference Product

Drug nameNplate®
INNRomiplostim
API typeFc-peptide fusion protein (peptibody)
Pharmacotherapeutic group
Antihaemorrhagics, other systemic haemostatics
ATC code
B02BX04
Target of antibody
TPO receptor (also known as cMpl)
General functionRomoplostim is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Nplate is indicated for the treatment of chronic primary immune thrombocytopenia (ITP) in paediatric patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins)
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Romiplostim is an Fc-peptide fusion protein (peptibody) that signals and activates intracellular transcriptional pathways via the TPO receptor (also known as cMpl) to increase platelet production. The peptibody molecule is comprised of a human immunoglobulin IgG1 Fc domain, with each single-chain subunit covalently linked at the C-terminus to a peptide chain containing 2 TPO receptor-binding domains. Romiplostim has no amino acid sequence homology to endogenous TPO. In pre-clinical and clinical trials no anti-romiplostim antibodies cross reacted with endogenous TPO.

The pharmacokinetics of romiplostim involved target-mediated disposition, which is presumably mediated by TPO receptors on platelets and other cells of the thrombopoietic lineage such as megakaryocytes.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)The pharmacokinetics of romiplostim involved target-mediated disposition, which is presumably mediated by TPO receptors on platelets and other cells of the thrombopoietic lineage such as megakaryocytes.

Due to the formation of neutralising antibodies pharmacodynamic effects of romiplostim in rats were often decreasing at prolonged duration of administration. Toxicokinetic studies showed no interaction of the antibodies with the measured concentrations.
Original license holder
Amgen Europe B.V.
Marketing authorisation numbers
EU/1/08/497/001
Marketing authorisation holder
Amgen Europe B.V. Minervum 7061 4817 ZK Breda The Netherlands
Name of the manufacturer of the biological active substance
Amgen Inc One Amgen Center Drive Thousand Oaks, CA 91320 USA
Name and address of the manufacturer(s) responsible for batch releaseAmgen Europe B.V. Minervum 7061 NL-4817 ZK Breda The Netherlands
Max shelf life
3 years
Storage conditions
2°C – 8°C
List of excipients
Mannitol (E421), Sucrose, L-histidine, Hydrochloric acid (for pH adjustment), Polysorbate 20
Evidentic Support
+49 (0) 30 959 99 8831

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