6mg Recombinant Human PEG-G-CSF PEG-rhG-CSF Injection Pegfilgrastim

6mg Recombinant Human PEG-G-CSF PEG-rhG-CSF Injection​ Pegfilgrastim

Product : PEG-G-CSF PEG-rhG-CSF Pegfilgrastim

Specification : 6mg:0.6ml

Standard : In - house

Packing : one vial/box

Description :

Pegfilgrastim is a covalent conjugate of recombinant methionyl human G-CSF (filgrastim) and monomethoxypolyethylene glycol. Filgrastim is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Filgrastim is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of filgrastim. The average molecular weight of pegfilgrastim is approximately 39 kD.

Indications and Usage :

Recombinant Human Pegylated Granulocyte Colony Stimulating Factor for Injection is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Recombinant Human Pegylated Granulocyte Colony Stimulating Factor for Injection is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Clinical Pharmacology

1. Mechanism of Action

Induces formation of neutrophil progenitor cells by binding to receptors on granulocytes, which then divide. Pegfilgrastim also potentiates the effects of mature neutrophils, thus reducing fever and the risk of infection from severe neutronpenia. It is pharmacologically identical to human granulocyte colony-stimulating factor.

2. Pharmacokinetics

The pharmacokinetics of pegfilgrastim were studied in 379 patients with cancer. The pharmacokinetics of pegfilgrastim were nonlinear and clearance decreased with increases in dose. Neutrophil receptor binding is an important component of the clearance of pegfilgrastim, and serum clearance is directly related to the number of neutrophils. In addition to numbers of neutrophils, body weight appeared to be a factor. Patients with higher body weights experienced higher systemic exposure to pegfilgrastim after receiving a dose normalized for body weight. A large variability in the pharmacokinetics of pegfilgrastim was observed. The half-life of Neulasta ranged from 15 to 80 hours after subcutaneous injection.

No gender-related differences were observed in the pharmacokinetics of pegfilgrastim, and no differences were observed in the pharmacokinetics of geriatric patients (≥ 65 years of age) compared with younger patients (< 65 years of age) [see Use in Specific Populations (8.5)]. The pharmacokinetics of pegfilgrastim were studied in pediatric patients with sarcoma. Renal dysfunction had no effect on the pharmacokinetics of pegfilgrastim. The pharmacokinetic profile in patients with hepatic insufficiency has not been assessed.