Recombinant Human Granulocyte Colony Stimulating Factor G-CSF / rhG-CSF Filgrastim Injection

Recombinant Human Granulocyte Colony Stimulating Factor G-CSF / rhG-CSF Filgrastim Injection

Product : Filgrastim Recombinant Human Granulocyte Colony-Stimulating Factor Injection G-CSF rhG-CSF

Specification : 75mcg, 150mcg, 300mcg vial and prefilled syringe

Standard : In - house

Packing : 1 vial/box, 1 PFS/box

Description :

Filgrastim is a recombinant, non-pegylated human granulocyte colony stimulating factor (G-CSF) analogue manufactured by recombinant DNA technology using a strain of E. coli. It is marketed as the brand name Neupogen by Amgen. Chemically, it consists of 175 amino acid residues. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis, except for the addition of an N-terminal methionine necessary for expression in E coli.

Indications and Dosages

➤➤To prevent infection after myelosuppressive chemotherapy

i.v. infusion

Adults and children. 5 mcg/kg daily over 15 to 30 min. Increased, as needed, by 5 mcg/kg with each chemotherapy cycle.

subcutaneous injection

Adults and children. 5 mcg/kg daily for up to 2 wk. Increased, as needed, by 5 mcg/kg with each chemotherapy cycle.

➤➤To reduce duration of neutropenia after bone marrow transplantation

i.v. infusion

Adults. 10 mcg/kg daily over 4 hr or as a continuous infusion over 24 hr.

subcutaneous infusion

Adults. 10 mcg/kg as a continuous infusion over 24 hr.

➤➤To enhance peripheral blood progenitor cell collection in autologous hematopoietic stem cell transplantation

subcutaneous infusion or injection

Adults. 10 mcg/kg as continuous infusion over 24 hr or a single injection, starting 4 days before first leukapheresis and continuing until last day of leukapheresis.

➤➤To reduce occurrence and duration of neutropenia in congenital neutropenia subcutaneous injection

Adults and children. 6 mcg/kg twice daily.

➤➤To reduce the occurrence and duration of neutropenia in idiopathic or cyclic neutropenia

subcutaneous injection

Adults and children. 5 mcg/kg daily. dosage adjustment Dosage reduced for patients whose absolute neutrophil count remains above 10,000/mm3.

Route      Onset          Peak        Duration

I.V.          In 5 min    Unknown    Unknown

Pharmacodynamics :

Used in the treatment of chemotherapy-induced neutropenia by enhancing the production of neutrophils. Filgrastim acts on hematopoietic cells by binding to specific cell surface receptors thereby stimulating proliferation, differentiation, commitment, and end cell functional activation. When tbo-filgrastim is administered to cancer patients, it took 3-5 days to reach maximum absolute neutrophil count (ANC). Levels of neutrophils returned to baseline by 21 days following completion of chemotherapy. In the healthy volunteer trials, doubling the tbo-filgrastim subcutaneous dose from 5 to 10 mcg/kg resulted in a 16-19% increase in the ANCmax and a 33-36% increase in the area under the effect curve for ANC.

Mechanism of action :

Filgrastim binds to the G-CSF receptor and stimulates the production of neutrophils in the bone marrow. As a G-CSF analog, it controls proliferation of committed progenitor cells and influences their maturation into mature neutrophils. Filgrastim also stimulates the release of neutrophils from bone marrow storage pools and reduces their maturation time. Filgrastim acts to increase the phagocytic activity of mature neutrophils. In patients receiving cytotoxic chemotherapy, Filgrastim can accelerate neutrophil recovery, leading to a reduction in duration of the neutropenic phase.