WebFood and Drug Administration (FDA) Approved Indications: • ® GRANIX (tbo-filgrastim) is a leukocyte growth factor indicated for reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a WebFDA Approved Indication(s) Granix is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia (FN).
Colony Stimulating Factors: Granix® (tbo-filgrastim)
WebThe indications for the medications are consistent with FDA approved indications, CMS coverage guidelines, National Comprehensive Cancer Network ... Granix 300 mcg prefilled syringe – 63459-0910-xx (Teva) Granix 400 mcg prefilled syringe – 63459-0912-xx (Teva) Max Units (per dose and over time): Webindication for mobilization or for myeloid malignancies . Efficacy (FDA Approved Indications) Literature Search Summary . A literature search was performed on PubMed/Medline (1966 to September 2014) using the search terms tbo-filgrastim and Granix and XM02. cody todd
HIGHLIGHTS OF PRESCRIBING INFORMATION …
WebIndication. GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs … Webfilgrastim (Granix), Filgrastim -aafi (Nivestym) Reference Number: CP.PHAR .297 Effective Date: 12.01.16 . Last Review Date: 05.20. ... Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – WebMay 1, 2024 · Other indications 5 mcg/kg daily for up to 14 days VI. Billing Code/Availability Information Jcode: J1447 - Injection, tbo-filgrastim, 1 microgram (1 microgram=1 billable unit) NDC: Granix 300 mcg prefilled syringe: 63459-0910-xx Granix 480 mcg prefilled syringe: 63459-0912-xx VII. References 1. Granix [package insert]. cody toler obituary