Oncology
Grasustek is a biosimilar medicinal product that contains the active substance Pegfilgrastim. Pegfilgrastim is a covalent conjugate of filgrastim molecule with polyethylenglycol (PEG). It is used for reduction in the duration of neutropenia (low levels of white blood cells) and the incidence of febrile neutropenia (neutropenia with fever) in adult patients treated with cytotoxic chemotherapy for malignancy. The substance promotes the formation of more white blood cells (functional neutrophil granulocytes) and their release from the bone marrow. Thus the risk of infection could be decreased. The special formulation as Pegfilgrastim compared to filgrastim, slows down the removal of filgrastim from the body, allowing the medicine to be given less often.
Pegfilgrastim
Human granulocyte-colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow. Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (r-metHuG-CSF) and is produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Pegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance.
Pegfilgrastim causes a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes.
Subcutaneous injection
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Solution for injection:
Not all pack sizes may be marketed.
