Nartograstim was approved by Pharmaceuticals and Medicals Devices Agency of Japan (PMDA) on April 1, 1994. It was originally developed by Kyowa Hakko Kiri, then marketed as Neu-up® by Yakult Honsha.
Nartograstim is a mutant recombinant human granulocyte colony-stimulating factor, which regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation‚ differentiation, and selected end-cell functions. It is indicated for the treatment of patients with congenital neutropenia, idiopathic neutropenia and neutropenia associated with bone marrow transplants or chemotherapy.
Neu-up® is available as injection (lyophilized powder) for subcutaneous and intravenous use, containing 25 μg, 50 μg, 100 μg or 250 μg of Nartograstim. The recommended starting dose is 1-2 μg/kg subcutaneously or intravenously (for patients with cancer receiving chemotherapy), 8 μg/kg intravenously (for patients with bone marrow transplants), 2 μg/kg subcutaneously or 4 μg/kg intravenously (for patients with congenital neutropenia and idiopathic neutropenia) once daily.
Update Date:2015-10-26
Update Date:2015-09-07
Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
---|---|---|---|---|---|---|---|
1998-01-26 | New strength | Neu-up | Neutropenia | Injection, Lyophilized powder, For solution | 25 μg | Yakult | |
1994-04-01 | First approval | Neu-up | Neutropenia | Injection, Lyophilized powder, For solution | 50 μg; 100 μg; 250 μg | Yakult |
Update Date:2015-09-07
Type | Recombinant cytokines | |
Source | Human | |
Molecular Formula | C850H1344N226O245S8 | |
Molecular Weight | 18905.7 | |
CAS No. | 62683-29-8 | |
Expression System | E.coli |