WebAug 6, 2024 · Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved GRANIX ® (tbo … WebGRANIX (tbo-filgrastim) ZARXIO (filgrastim-sndz) NIVESTYM (filgrastim-aafi) POLICY I. INDICATIONS The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. A. FDA-Approved Indications
GRANIX (tbo-filgrastim) Injection
WebTbo-filgrastim exhibits nonlinear pharmacokinetics. Doubling the dose from 5 to 10 mcg/kg resulted in an approximately 2.5-fold increase in the Cmax value and a 3-fold increase in the AUC value. In adult patients enrolled in 3 studies, the geometric mean Cmax values were 20 to 31 ng/mL (coefficient of variation (CV), 24% to 65%) at a median ... WebAug 6, 2024 · Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved GRANIX ® (tbo-filgrastim) Injection for a new vial presentation and indication in pediatric patients 1 month and older. GRANIX is indicated to reduce the duration of severe neutropenia in adult and … population of shreveport louisiana 2022
SPECIALTY GUIDELINE MANAGEMENT - NC
WebGRANIX safely and effectively. See full prescribing information for GRANIX. GRANIX. TM (tbo-filgrastim) Injection, for subcutaneous use Initial U.S. Approval: 2012 -----INDICATIONS AND USAGE----- GRANIX (tbo-filgrastim) is a leukocyte growth factor indicated for reduction in the duration of severe neutropenia in patients with non-myeloid ... WebIndicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia 5 mcg/kg SC/IV... Web1. Is Granix prescribed by or given in consultation with a hematologist or oncologist for the following indication? • Adult and pediatric patients 1 month of age and older with a nonmyeloid malignancy who is receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever population of shrewsbury vt