KidiPeg®


(Pegylated Filgrastim)

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Description

KidiPeg® (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 kilo Daltons (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.

KidiPeg® is supplied in 0.3 mL prefilled syringes for subcutaneous injection. Each syringe contains 3 mg pegfilgrastim (based on protein weight) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate, polysorbate 20, sodium, and sorbitol in water for Injection, USP.

Indication and Usage

KidiPeg® 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 (FDA approved in pediatric patients [age not specified]).

KidiPeg® is also indicated to decrease the incidence of infection in patients undergoing radiation neutropenia (FDA approved in pediatric patients [age not specified]).

KidiPeg® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

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