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Therapeutic Romiplostim fusion protein from the original Nplate® commercial drug.
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ProductBatch | Antigen | Molecular Class | Drug Brand | Product Concentration | CoA | Quantity per vial | Storage Temperature | Expiry Date | Price from | |
|---|---|---|---|---|---|---|---|---|---|---|
TPO receptor (cMpl) |
Peptibody , Therapeutic peptides |
Nplate® |
0,5 mg/mL |
– |
0,02 mg |
-80°C |
05/2025 |
613,00 € |
| Drug name | Nplate® |
| INN | Romiplostim |
| API type | Fc-peptide fusion protein (peptibody) |
| Pharmacotherapeutic group | Antihaemorrhagics, other systemic haemostatics |
| ATC code | B02BX04 |
| Target of antibody | TPO receptor (also known as cMpl) |
| General function | Romoplostim 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 release | Amgen 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 |
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