Tbo Filgrastim Package Insert

HIGHLIGHTS OF PRESCRIBING INFORMATION ... - GRANIX
GRANIX® (tbo-fi lgrastim) injection GRANIX® (tbo-fi lgrastim) injection 2.3 Instructions for Use of the Safety Needle Guard Device by Healthcare Professionals Hold the syringe assembly by the open sides of the device and remove the needle shield. Expel any extra volume depending on dose needed. ... Doc Retrieval

References - Securecms.highmark.com
References I-88 1. Neupogen (Filgrastim) [package insert]. Thousand Oaks, CA. Amgen Inc. Revised 07/2015. 2. National Comprehensive Cancer Network (NCCN). ... Retrieve Doc

Aetna Better Health
10. Hermans P, Rozenbaum W, Jou A, et al. Filgrastim to treat neutropenia and support myelosuppressive medication dosing in HIV infection. G-CSF 92105 Study Group. AIDS. 1996;10(14):1627 -1633. 11. Hermans P, R ozenbaum W, Jou A, et al. Filgrastim to treat neutropenia and support myelosuppressive medication dosing in HIV infection. ... Fetch Doc

Drug Therapy Guidelines Colony Stimulating Factors (CSFs ...
Package Insert: Granix (Tbo-filgrastim). Teva Pharmaceuticals. North Wales, PA 19454. Revised 6/2017 The Plan fully expects that only appropriate and medically necessary services will be rendered. The Plan reserves the right to conduct pre-payment and post-payment ... Read Here

Colony Stimulating Factors: Granix® (tbo-filgrastim)
Trifilio S, Zhou Z, Galvin J, Fong JL, Monreal J, Mehta J. Filgrastim versus TBO-filgrastim to reduce the duration of neutropenia after autologous hematopoietic stem cell transplantation: TBO, or not TBO, that is the question. ... Content Retrieval

Tbo-Filgrastim (Granix) National Drug Monograph - December 2014
Tbo-filgrastim Monograph In the registration trial in breast cancer tbo-filgrastim was superior to placebo in cycle 1 of myelosuppressive chemotherapy for the primary endpoint of duration of severe neutropenia. Equivalence was shown to filgrastim for the primary endpoint of duration of severe neutropenia. ... Fetch Document

Neupogen (filgrastim), Granix (tbo-filgrastim), Nivestym ...
Neupogen (filgrastim), Granix (tbo-filgrastim), Nivestym (filgrastim-aafi), Zarxio (filgrastim-sndz) Neupogen Granix Nivestym Zarxio FEP Clinical Rationale Filgrastim is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with AML (1-4). 3. ... Fetch Here

Clinical Policy: Filgrastim (Neupogen), Filgrastim -sndz ...
Package insert), is known to be safe and effective. However, a shorter duration of Filgrastim, Filgrastim-sndz, Tbo-filgrastim . Page 6 of 7 7. National Comprehensive Cancer Network. Myeloid Growth Factors Version 1.2018. ... Document Viewer

Therapeutic Class Overview Colony Stimulating Factors
(Neupogen®), filgrastim-sndz (Zarxio®), and tbo-filgrastim (Granix®). While filgrastim -sndz and tbo- While filgrastim -sndz and tbo- filgrastim are the same recombinant human G-CSF as filgrastim, only filgrastim-sndz is considered a ... Read Here

Biosimilars: Balancing The Promise With The Realities Of Practice
• 254 tbo-filgrastim case reports and 461 adverse reactions • Most commonly occurring terms = allergic type reactions (11), interstitial pneumonia (4) and splenomegaly (2) ... Access Full Source

Filgrastim-sndz (ZARXIO)
Package insert lists common adverse reactions from reference labeling. Low incidence of serious adverse reactions. Other Considerations Do not administer to patients with latex allergy. Projected Place in Therapy product licensed in Filgrastim-sndz has been shown to be biosimilar to the reference filgrastim the U.S. ... Read Full Source

The Critical Intersection Of Cost, Quality And Outcomes
Tbo-filgrastim is a short-acting recombinant form of G-CSF, indicated to stimulate neutrophil production in adults who become neutropenic while undergoing chemotherapy for nonmyeloid malignancies. In the efficacy study of tbo-filgrastim, the effectiveness was determined based on study results that showed that patients receiving tbo-filgrastim ... Read More

Clinical Policy: Filgrastim (Neupogen), Filgrastim-sndz ...
The expected chemotherapy-induced neutrophil nadir (as specified in the G-CSF package insert), is known to be safe and effective. However, a shorter duration of administration that is sufficient Filgrastim, Filgrastim-sndz, Tbo-filgrastim . Page . 4. of . 6. to achieve clinically adequate ... Read Document

Reference ID: 3182182 - Food And Drug Administration
The recommended dose of tbo-filgrastim is 5 mcg/kg per day administered as a subcutaneous injection. Administer the first dose of tbo-filgrastim no earlier than 24 hours following myelosuppressive chemotherapy. Do not administer tbo-filgrastim within 24 hours prior to chemotherapy [see Warnings and Precautions (5)]. ... Access This Document

Clinical Policy: Filgrastim (Neupogen), Filgrastim -sndz ...
Filgrastim (Neupogen®) and its biosimilars, filgrastim-sndz (Zarxio®) and tbo-filgrastim CSF package insert), is known to be safe and effective. However, a shorter duration of administration that is sufficient to achieve clinically adequate neutrophil recovery is a ... Read More

Reference ID: 3675736 - Food And Drug Administration
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 ... Visit Document