The Food and Drug Administration has expanded the indication for Granix (tbo-filgrastim; Teva) to include treatment in pediatric patients. Specifically, this human granulocyte colony-stimulating factor (G-CSF) is now approved to reduce the duration of severe neutropenia in adult and pediatric patients ≥1 month old with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant incidence of febrile neutropenia.
The pediatric approval was supported by evidence from studies in adults with additional safety and pharmacokinetics data from a single-arm trial of 50 pediatric patients with solid tumors treated with Granix for chemotherapy-induced neutropenia. The pharmacokinetics and safety profile of the treatment in the pediatric population were found to be similar to those seen in adults.
The single-dose prefilled syringes (300mcg/0.5mL, 480mcg/0.8mL) will continue to be available as well.
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