The potency of this medicinal product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class. For more information, refer to the PHARMACOLOGY. Pharmacotherapeutic group: Immunostimulants, Colony stimulating factors, ATC code: L03AA14 Pharmacological Actions Mechanism of action Human G-CSF is a glycoprotein that regulates the production and release of functional neutrophils from the bone marrow. Filgrastim is an un-glycosylated recombinant methionyl human G-CSF. Lipegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance. Lipegfilgrastim binds to human the G-CSF receptor like filgrastim and pegfilgrastim. Pharmacodynamics effects Lipegfilgrastim and filgrastim induced a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes. These results suggest that the G-CSF moiety of lipegfilgrastim confers the expected activity of this growth factor: stimulation of proliferation of haematopoietic progenitor cells, differentiation into mature cells and release into the peripheral blood. This effect includes not only the neutrophil lineage but extends to other single lineage and multilineage progenitors and pluripotent haematopoietic stem cells. G-CSF also increases the antibacterial activities of neutrophils including the phagocytosis. Pharmacokinetics Absorption Following initial sc administration of lipegfilgrastim in healthy subjects, a lag in absorption of approximately 1 hour is observed with maximum serum concentrations being attained at approximately 35 hours after dose administration. Given its molecular weight, lipegfilgrastim is believed to be primarily absorbed via the lymphatic system then drained into the vascular system. Following repeated administration in patients 4), mean serum concentrations of lipegfilgrastim are consistently lower than after a single dose. Maximum serum concentrations after repeat doses were attained earlier (8 to 24 hours after dose
The potency of this medicinal product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class. For more information, refer to the PHARMACOLOGY. Pharmacotherapeutic group: Immunostimulants, Colony stimulating factors, ATC code: L03AA14 Pharmacological Actions Mechanism of action Human G-CSF is a glycoprotein that regulates the production and release of functional neutrophils from the bone marrow. Filgrastim is an un-glycosylated recombinant methionyl human G-CSF. Lipegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance. Lipegfilgrastim binds to human the G-CSF receptor like filgrastim and pegfilgrastim. Pharmacodynamics effects Lipegfilgrastim and filgrastim induced a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes. These results suggest that the G-CSF moiety of lipegfilgrastim confers the expected activity of this growth factor: stimulation of proliferation of haematopoietic progenitor cells, differentiation into mature cells and release into the peripheral blood. This effect includes not only the neutrophil lineage but extends to other single lineage and multilineage progenitors and pluripotent haematopoietic stem cells. G-CSF also increases the antibacterial activities of neutrophils including the phagocytosis. Pharmacokinetics Absorption Following initial sc administration of lipegfilgrastim in healthy subjects, a lag in absorption of approximately 1 hour is observed with maximum serum concentrations being attained at approximately 35 hours after dose administration. Given its molecular weight, lipegfilgrastim is believed to be primarily absorbed via the lymphatic system then drained into the vascular system. Following repeated administration in patients 4), mean serum concentrations of lipegfilgrastim are consistently lower than after a single dose. Maximum serum concentrations after repeat doses were attained earlier (8 to 24 hours after dose
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