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Filgrastim

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https://www.readbyqxmd.com/read/28090158/zarxio-filgrastim-sndz-the-first-biosimilar-approved-by-the-fda
#1
Mina Awad, Pavit Singh, Olga Hilas
Zarxio (filgrastim-sndz), a biosimilar for the treatment of severe chronic neutropenia.
January 2017: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/28049914/comparison-of-the-adsorption-of-original-and-biosimilar-preparations-of-filgrastim-on-infusion-sets-and-the-inhibition-of-adsorption-by-polysorbate-80
#2
Mio Tange, Akino Matsumoto, Miyako Yoshida, Honami Kojima, Tamami Haraguchi, Takahiro Uchida
The purpose of the study was to evaluate the adsorption of filgrastim on infusion sets (comprising infusion bag, line and filter) and to compare the adsorption of the original filgrastim preparation with biosimilar preparations using HPLC. The inhibitory effect of polysorbate 80 on this adsorption was also evaluated. Filgrastim was mixed with isotonic sodium chloride solution or 5% (w/v) glucose solution in the infusion fluid. Filgrastim adsorption on infusion sets was observed with all preparations and with both types of infusion solution...
2017: Chemical & Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/28007722/physical-compatibility-of-isavuconazonium-sulfate-with-select-i-v-drugs-during-simulated-y-site-administration
#3
Wonhee So, Liz Kim, Abrar K Thabit, David P Nicolau, Joseph L Kuti
PURPOSE: The physical compatibility of isavuconazonium sulfate with 95 i.v. drugs during simulated Y-site administration was studied. METHODS: Isavuconazonium sulfate for injection and all other drugs were reconstituted according to the manufacturer's recommendation and further diluted with 0.9% sodium chloride injection or 5% dextrose injection to a final concentration (1.5 mg/mL for isavuconazonium sulfate and standard concentrations used clinically for other drugs)...
January 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/27972623/tbo-filgrastim-patterns-of-care-by-treatment-site-and-setting-in-the-united-states-2014-and-2015
#4
K E Smoyer, J Radtchenko, D Garofalo, C A Jones, P B Lane, B Feinberg
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27929743/knowledge-behaviors-and-practices-of-community-and-hospital-pharmacists-towards-biosimilar-medicines-results-of-a-french-web-based-survey
#5
Morgane Beck, Bruno Michel, Marie-Christine Rybarczyk-Vigouret, Dominique Levêque, Christelle Sordet, Jean Sibilia, Michel Velten
This study's aims were: 1) to extract a comprehensive overview of the knowledge, experience and opinions of both community pharmacists and hospital pharmacists regarding biosimilar medicines in France; and 2) to identify the perceived problems and solutions to promoting their prescription. A 2015 web-based survey was conducted by the Observatoire des Médicaments, des Dispositifs Médicaux et de l'Innovation Thérapeutique of Alsace. A total of 802 pharmacists responded to the survey. Many (536, 66.8%, [95% confidence interval (CI) 63...
December 8, 2016: MAbs
https://www.readbyqxmd.com/read/27928760/cost-effectiveness-analysis-of-prophylaxis-treatment-strategies-to-reduce-the-incidence-of-febrile-neutropenia-in-patients-with-early-stage-breast-cancer-or-non-hodgkin-lymphoma
#6
Kelly Fust, Xiaoyan Li, Michael Maschio, Guillermo Villa, Anju Parthan, Richard Barron, Milton C Weinstein, Luc Somers, Caroline Hoefkens, Gary H Lyman
OBJECTIVE: The objective of this study was to evaluate the cost effectiveness of no prophylaxis, primary prophylaxis (PP), or secondary prophylaxis (SP) with granulocyte colony-stimulating factors (G-CSFs), i.e., pegfilgrastim, lipegfilgrastim, filgrastim (6- and 11-day), or lenograstim (6- and 11-day), to reduce the incidence of febrile neutropenia (FN) in patients with stage II breast cancer receiving TC (docetaxel, cyclophosphamide) and in patients with non-Hodgkin lymphoma (NHL) receiving R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) over a lifetime horizon from a Belgian payer perspective...
December 7, 2016: PharmacoEconomics
https://www.readbyqxmd.com/read/27920647/febrile-neutropenia-with-thrombocytopenia-after-infliximab-induction-in-a-patient-with-ulcerative-colitis
#7
Gustavo Gomez, Shifa Umar, Mohammad Bilal, Cristina Strahotin, Kofi Clarke
A 34-year-old female with left-sided ulcerative colitis (UC) developed severe febrile neutropenia/thrombocytopenia soon after infliximab induction therapy. There was no other plausible cause of the cell line abnormalities other than an accurate temporal association with infliximab administration. Supportive care, broad-spectrum antibiotic, and single dose of filgrastim was given on day 5 of admission due to persistently low absolute neutrophil count and fevers. The cell lines recovered, fever resolved and the patient made a complete clinical recovery...
September 2016: Case Reports in Gastroenterology
https://www.readbyqxmd.com/read/27904448/mobilization-with-cyclophosphamide-reduces-the-number-of-lymphocyte-subpopulations-in-the-leukapheresis-product-and-delays-their-reconstitution-after-autologous-hematopoietic-stem-cell-transplantation-in-patients-with-multiple-myeloma
#8
Matevz Skerget, Barbara Skopec, Darja Zontar, Peter Cernelc
BACKGROUND: Autologous hematopoietic stem cell transplantation is considered the standard of care for younger patients with multiple myeloma. Several mobilization regimens are currently used, most commonly growth factors alone or in combination with chemotherapy. The aim of our study was to investigate the differences in lymphocyte subpopulation counts between three different mobilization regimens on collection day, in the leukapheresis product and on day 15 after autologous hematopoietic stem cell transplantation...
December 1, 2016: Radiology and Oncology
https://www.readbyqxmd.com/read/27876365/midyear-commentary-on-trends-in-drug-delivery-and-clinical-translational-medicine-growth-in-biosimilar-complex-injectable-drug-formulation-products-within-evolving-collaborative-regulatory-interagency-fda-ftc-and-doj-practices-and-enforcement
#9
Rodney J Y Ho
Before the 2009 Biologics Price Competition and Innovation Act that enabled the U.S. Federal Drug Administration (FDA) to create the 351(k) Biologic License Application-an abbreviated biosimilar approval process, FDA approved follow-on biomolecule products such as beta-interferon, glucagon, hyaluronidase, and somatropin (human growth hormone) under varying and evolving rules. With the 351(k) Biologic License Application biosimilar approval process in place, currently, there are 4 (licensed in 2015-2016) biosimilars available, namely Neupogen (filgrastim; $1 B/y), Humira (adalumumab; $14...
February 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27829539/chemotherapy-induced-febrile-neutropenia-prophylaxis-with-biosimilar-filgrastim-in-elderly-versus-non-elderly-cancer-patients-patterns-outcomes-and-determinants-monitor-gcsf-study
#10
Matti Aapro, Carsten Bokemeyer, Heinz Ludwig, Pere Gascón, Mario Boccadoro, Kris Denhaerynck, Michael Gorray, Andriy Krendyukov, Karen MacDonald, Ivo Abraham
BACKGROUND: Myelotoxic chemotherapy is associated with chemotherapy-induced (febrile) neutropenia (CIN/FN). The MONITOR-GCSF study evaluated biosimilar filgrastim (Zarzio®) prophylaxis patterns, associated outcomes, and determinants. We performed stratified analyses comparing elderly and non-elderly patients. METHODS: Comparative (elderly/non-elderly) analysis of demographics and clinical status, prophylaxis, associated CIN/FN outcomes (CIN grade 4 [CIN4], FN, CIN/FN-related hospitalizations and chemodisturbances, composite), and, per hierarchical modeling, determinants thereof evaluated at the patient- and cycle-level...
November 6, 2016: Journal of Geriatric Oncology
https://www.readbyqxmd.com/read/27821391/filgrastim-becomes-biosimilar-test-case-for-hospitals
#11
Kate Traynor
No abstract text is available yet for this article.
November 15, 2016: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/27793849/predictive-modeling-of-the-outcomes-of-chemotherapy-induced-febrile-neutropenia-prophylaxis-with-biosimilar-filgrastim-monitor-gcsf-study
#12
M Aapro, H Ludwig, C Bokemeyer, P Gascón, M Boccadoro, K Denhaerynck, A Krendyukov, M Gorray, K MacDonald, I Abraham
BACKGROUND: Risk models of chemotherapy-induced (CIN) and febrile neutropenia (FN) have to date focused on determinants measured at the start of chemotherapy. We extended this static approach with a dynamic approach of CIN/FN risk modeling at the start of each cycle. DESIGN: We applied predictive modeling using multivariate logistic regression to identify determinants of CIN/FN episodes and related hospitalizations and chemotherapy disturbances (CIN/FN consequences) in analyses at the patient ('ever' during the whole period of chemotherapy) and cycle-level (during a given chemotherapy cycle)...
November 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/27792717/-comparison-of-the-effectiveness-of-hematopoietic-cell-mobilization-with-chemotherapy-and-filgrastim-versus-filgrastim-alone-for-autologous-transplant-in-patients-with-lymphoma
#13
César Homero Gutiérrez-Aguirre, Fernando De la Garza-Salazar, Olga Cantú-Rodríguez, Óscar González-Llano, José C Jaime-Pérez, Consuelo Mancias-Guerra, Ricardo García-Sepúlveda, Rosario Salazar-Riojas, David Gómez-Almaguer
INTRODUCTION: Autologous hematopoietic stem cell transplantation is the treatment of choice for high-risk Hodgkin's lymphoma and non-Hodgkin's lymphoma. OBJECTIVE: Compare the capacity to mobilize CD34+ cells for autologous hematopoietic stem cell transplantation using schemes with chemotherapy and without chemotherapy plus filgrastim in patients diagnosed with Hodgkin's lymphoma or non-Hodgkin's lymphoma. MATERIAL AND METHODS: The clinical records of patients with Hodgkin's lymphoma or non-Hodgkin's lymphoma who received an autologous hematopoietic stem cell transplant were analyzed retrospectively...
October 2016: Gaceta Médica de México
https://www.readbyqxmd.com/read/27789277/erratum-to-filgrastim-stimulated-bone-marrow-compared-with-filgrastim-mobilized-peripheral-blood-in-myeloablative-sibling-allografting-for-patients-with-hematologic-malignancies-a-randomized-canadian-blood-and-marrow-transplant-group-study-biol-blood-marrow
#14
Stephen Couban, Mahmoud Aljurf, Sylvie Lachance, Irwin Walker, Cynthia Toze, Morel Rubinger, Jeffrey H Lipton, Stephanie J Lee, Jeff Szer, Richard Doocey, Ian D Lewis, Lothar Huebsch, Kang Howson-Jan, Michel Lalancette, Fahad Almohareb, Nadeem Chaudhri, Sabine Ivison, Raewyn Broady, Megan Levings, Diane Fairclough, Gerald Devins, David Szwajcer, Ronan Foley, Clayton Smith, Tony Panzarella, Holly Kerr, Amina Kariminia, Kirk R Schultz
No abstract text is available yet for this article.
October 24, 2016: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/27783280/optimal-primary-febrile-neutropenia-prophylaxis-for-patients-receiving-docetaxel-cyclophosphamide-chemotherapy-for-breast-cancer-a-systematic-review
#15
REVIEW
Ricardo Fernandes, Sasha Mazzarello, Carol Stober, Lisa Vandermeer, Shaan Dudani, Mohamed F K Ibrahim, Habeeb Majeed, Kirstin Perdrizet, Risa Shorr, Brian Hutton, Dean Fergusson, Mark Clemons
BACKGROUND: Due to the high rate of febrile neutropenia (FN) with docetaxel-cyclophosphamide (DC) chemotherapy, primary FN prophylaxis is recommended. However, the optimal choice of prophylaxis [i.e., granulocyte-colony stimulating factors (G-CSF) or antibiotics] is unknown. A systematic review was performed to address this knowledge gap. METHODS: Embase, Ovid Medline, Pubmed, the Cochrane database of systematic reviews, and Cochrane register of controlled trials were searched from 1946 to April 2016 for studies evaluating primary prophylactic FN treatments in breast cancer patients receiving DC chemotherapy...
October 25, 2016: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/27765329/effect-of-g-csf-on-oral-mucositis-and-traumatic-ulcers-produced-in-the-tongue-of-rats-undergoing-radiotherapy-clinical-and-histologic-evaluation
#16
Juliana Jasper, Sérgio Roithmann, Renata Stifelman Camilotti, Fernanda Gonçalves Salum, Karen Cherubini, Maria Antonia Zancanaro de Figueiredo
OBJECTIVE: To investigate the effect of granulocyte colony-stimulating factor (G-CSF) on oral mucositis (OM) and on the healing of traumatic ulcers produced in the tongue of rats undergoing radiotherapy (RT). STUDY DESIGN: Twenty-seven Wistar rats were assigned to four groups: (1) RT + traumatic ulcer + filgrastim (G-CSF analog; n = 7); (2) RT + traumatic ulcer + saline (n = 7); (3) no RT + traumatic ulcer + filgrastim (n = 7); and (4) no RT + traumatic ulcer (n = 6)...
November 2016: Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
https://www.readbyqxmd.com/read/27759847/a-phase-iii-randomized-non-inferiority-study-comparing-the-efficacy-and-safety-of-biosimilar-filgrastim-versus-originator-filgrastim-for-chemotherapy-induced-neutropenia-in-breast-cancer-patients
#17
Roberto Hegg, André Mattar, João Nunes de Matos-Neto, José Luiz Pedrini, Sabina Bandeira Aleixo, Roberto Odebrecht Rocha, Renato Peixoto Cramer-Junior, Sylvie van-Eyll-Rocha
OBJECTIVES: To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapy-induced neutropenia and to evaluate the non-inferiority of the test drug relative to the originator. METHODS: This phase III non-inferiority study had a randomized, multicenter, and open-label design. The patients were randomized at a ratio of 1:1 with a follow-up period of 6 weeks for each patient. In both study arms, filgrastim was administered subcutaneously at a daily dose of 5 mg/kg body weight...
October 1, 2016: Clinics
https://www.readbyqxmd.com/read/27751704/when-hydromorphone-is-not-working-try-loratadine-an-emergency-department-case-of-loratadine-as-abortive-therapy-for-severe-pegfilgrastim-induced-bone-pain
#18
Katherine Moore, Rachel Haroz
BACKGROUND: Intractable bone pain is a notorious adverse effect of granulocyte-colony stimulating factors (G-CSFs), such as pegfilgrastim and filgrastim, which are given to help prevent neutropenia in patients who are undergoing chemotherapy. G-CSF-induced bone pain is surprisingly common and often refractory to treatment with conventional analgesics. CASE REPORT: This article describes an emergency department case of opiate and nonsteroidal anti-inflammatory drug-resistant pegfilgrastim-induced bone pain that was successfully alleviated with 10 mg of oral loratadine, allowing for discharge home...
October 14, 2016: Journal of Emergency Medicine
https://www.readbyqxmd.com/read/27743353/compatibility-of-biosimilar-filgrastim-with-cytotoxic-chemotherapy-during-the-treatment-of-malignant-diseases-venice-a-prospective-multicenter-non-interventional-longitudinal-study
#19
Stefan Fruehauf, Burkhard Otremba, Oliver Stötzer, Christine Rudolph
INTRODUCTION: Febrile neutropenia (FN) is a serious and frequent complication of cytotoxic chemotherapy. Biosimilar filgrastim (Nivestim™, Hospira Inc, A Pfizer Company, Lake Forest, IL, USA) is a granulocyte-colony stimulating factor licensed for the treatment of neutropenia and FN induced by myelosuppressive chemotherapy. The primary goal of this VENICE study (ClinicalTrials.gov identifier, NCT01627990) was to observe the tolerability, safety and efficacy of biosimilar filgrastim in patients receiving cancer chemotherapy...
November 2016: Advances in Therapy
https://www.readbyqxmd.com/read/27709313/a-randomized-multi-center-open-label-phase-iii-study-of-once-per-cycle-da-3031-a-pegylated-g-csf-in-comparison-with-daily-filgrastim-in-patients-receiving-tac-chemotherapy-for-breast-cancer
#20
K H Park, S Lee, J H Park, S Y Kang, H Y Kim, I H Park, Y H Park, Y H Im, H J Lee, S Park, S I Lee, K H Jung, Y S Kim, Jae Hong Seo
PURPOSE: This multi-center, randomized, phase III study was conducted to demonstrate the non-inferiority of DA-3031 compared with daily filgrastim in patients during the first cycle of chemotherapy for breast cancer in terms of the duration of severe neutropenia (DSN). METHODS: Seventy-four patients with breast cancer who were receiving combination chemotherapy with docetaxel, doxorubicin, and cyclophosphamide (TAC) were enrolled. All participants were randomized to receive either daily subcutaneous injections of filgrastim 100 μg/m(2)/day for up to 10 days or a single subcutaneous injection of DA-3031 at fixed doses of 6 mg on day 2 of each chemotherapy cycle...
February 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
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