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Filgrastim

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https://www.readbyqxmd.com/read/28300458/peripheral-blood-stem-cell-mobilization-with-a-single-dose-of-peg-filgrastim-in-patients-with-multiple-myeloma-previously-treated-with-radiotherapy
#1
Alfonso T Anguita-Compagnon, Maria T Dibarrart, Laura Paredes, Daniel Araos, Marcela Vargas, Alejandro Majlis
No abstract text is available yet for this article.
March 16, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28278727/biosimilars-of-filgrastim-in-autologous-stem-cell-transplantation-certain-differences-for-myeloma-patients-only
#2
Christophe Nicol, Chloé Henry, Marie-Anne Couturier, Pascal Delépine, Céline Tripogney, Caroline Buors, Gaëlle Guillerm, Christian Berthou, Adrian Tempescul, Jean-Christophe Ianotto
No abstract text is available yet for this article.
February 7, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28254831/false-homozygous-hla-genotyping-results-due-to-copy-number-neutral-loss-of-heterozygosity-in-acquired-aplastic-anaemia
#3
Bert Heyrman, Ann De Becker, Sonja Verheyden, Christian Demanet
The aim of this case report is to draw attention on possible false human leucocyte antigen (HLA) genotyping in acquired aplastic anaemia prior to allogeneic haematopoietic stem cell transplantation. In acquired aplastic anaemia loss of heterozygosity (LOH) of chromosome 6p is known to occur in around 12%. We report false HLA genotyping results due to LOH and a coinciding steep rise in neutrophils following filgrastim stimulation in a patient with very severe aplastic anaemia. At diagnosis we obtained heterozygous results on peripheral blood...
March 2, 2017: BMJ Case Reports
https://www.readbyqxmd.com/read/28254519/assessment-of-the-structure-of-pegylated-recombinant-protein-therapeutics-by-the-nmr-fingerprint-assay
#4
Derek J Hodgson, Yves Aubin
A number of recombinant protein therapeutic products, such as filgrastim (methionyl granulocyte colony stimulating factor [Met-GCSF] used to boost the immune system in chemotherapy treated cancer patients), and interferon alpha-2 (used for the treatment of various viral infections), have been chemically modified with the addition of a polyethylene glycol (PEG) chain. This modification prolongs residency of the drug in the body and reduces metabolic degradation, which allows less frequent administration of the products...
February 16, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28238900/safety-and-biosimilarity-of-ior-%C3%A2-leukocim-compared-to-neupogen-%C3%A2-based-on-toxicity-pharmacodynamic-and-pharmacokinetic-studies-in-the-sprague-dawley-rat
#5
Albert Licollari, Katherine Riddle, Simon R Taylor, Nuris Ledon, Gordon T Bolger
This study examined the safety, pharmacodynamic and pharmacokinetic similarity of the human recombinant filgrastim products ior(®)LeukoCIM and Neupogen(®) following a 28-day repeated subcutaneous dose administration in male and female Sprague-Dawley rats with a 14-day recovery period. Safety profiling was based on clinical observations, clinical pathology, and pathology findings for control rats dosed with vehicle and rats dosed either with 15, 75, and 150 μg/kg of ior(®)LeukoCIM or with 150 μg/kg of Neupogen(®)...
February 24, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28194031/hematopoietic-stem-cell-remobilization-with-vinorelbine-and-filgrastim-in-aml
#6
V Blum, A D Heini, U Novak, B M Taleghani, G M Baerlocher, K Leibundgut, K Seipel, Y Banz, M Bargetzi, T Pabst
No abstract text is available yet for this article.
February 13, 2017: Bone Marrow Transplantation
https://www.readbyqxmd.com/read/28182150/evaluation-of-a-biosimilar-granulocyte-colony-stimulating-factor-filgrastim-xm02-for-peripheral-blood-stem-cell-mobilization-and-transplantation-a-single-center-experience-in-japan
#7
Hideaki Yoshimura, Masaaki Hotta, Takahisa Nakanishi, Shinya Fujita, Aya Nakaya, Atsushi Satake, Tomoki Ito, Kazuyoshi Ishii, Shosaku Nomura
BACKGROUND: Biosimilar granulocyte colony-stimulating factor (G-CSF) has recently been introduced into clinical practice. G-CSFs are used to mobilize CD34(+) cells and accelerate engraftment after transplantation. However, in Asia, particularly in Japan, data for peripheral blood stem cell (PBSC) mobilization by this biosimilar G-CSF are currently lacking. Therefore, the clinical efficacy and safety of biosimilar G-CSF for hematopoietic stem cell transplantation needs to be evaluated in a Japanese context...
2017: Journal of Blood Medicine
https://www.readbyqxmd.com/read/28164135/role-of-cd8-regulatory-t-cells-versus-tc1-and-tc17-cells-in-the-development-of-human-graft-versus-host-disease
#8
Adriana Gutiérrez-Hoya, Rubén López-Santiago, Jorge Vela-Ojeda, Laura Montiel-Cervantes, Octavio Rodríguez-Cortés, Víctor Rosales-García, Vladimir Paredes-Cervantes, Raúl Flores-Mejía, Daniela Sandoval-Borrego, Martha Moreno-Lafont
CD8(+) T cells that secrete proinflammatory cytokines play a central role in exacerbation of inflammation; however, a new subpopulation of CD8 regulatory T cells has recently been characterized. This study analyzes the prominent role of these different subpopulations in the development of graft-versus-host disease (GVHD). Samples from 8 healthy donors mobilized with Filgrastim® (G-CSF) and 18 patients who underwent allogeneic hematopoietic stem cell transplantation (HSCT) were evaluated by flow cytometry. Mobilization induced an increase in Tc1 (p < 0...
2017: Journal of Immunology Research
https://www.readbyqxmd.com/read/28152926/cancer-care-decision-support-for-wbc-growth-factors-gf-geographic-differences-in-utilization-and-provider-malleability
#9
Kenneth Sherman Wurtz, Anna DiMarco, Lourdes Feliciano, Dinah Faith Q Huff, Kevin B Knopf, William J Hrushesky, Michael Baum
128 Background: Growth factor use is the largest single category of drug expenditure for US cancer patients. Oncology Analytics is a decision support company that assists physicians in determining the appropriate use of GF based on the NCCN, ASCO, and ASH guidelines and the level one data that underlies these guidelines. We hypothesized that there would be geographic variation among GF preference and in the malleability of those practice patterns after OA entered a market. We determined the proportion of initial pegfilgrastim requests for preauthorization over other types of GF as well as the review outcomes and final drug of choice after OA intervention of inappropriate GF requests across three specific jurisdictions: Florida, Puerto Rico, Georgia and Texas...
March 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28111718/over-and-under-prophylaxis-for-chemotherapy-induced-febrile-neutropenia-relative-to-evidence-based-guidelines-is-associated-with-differences-in-outcomes-findings-from-the-monitor-gcsf-study
#10
Carsten Bokemeyer, Pere Gascón, Matti Aapro, Heinz Ludwig, Mario Boccadoro, Kris Denhaerynck, Michael Gorray, Andriy Krendyukov, Ivo Abraham, Karen MacDonald
PURPOSE: In the MONITOR-GCSF study of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim, 56.6% of patients were prophylacted according to amended EORTC guidelines, but 17.4% were prophylacted below and 26.0% above guideline recommendations. METHODS: MONITOR-GCSF is a prospective, observational study of 1447 evaluable patients from 140 cancers centers in 12 European countries treated with myelosuppressive chemotherapy for up to 6 cycles receiving biosimilar GCSF prophylaxis...
January 22, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28090158/zarxio-filgrastim-sndz-the-first-biosimilar-approved-by-the-fda
#11
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
#12
COMPARATIVE STUDY
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
#13
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
#14
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
#15
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...
February 2017: 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
#16
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...
April 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/27920647/febrile-neutropenia-with-thrombocytopenia-after-infliximab-induction-in-a-patient-with-ulcerative-colitis
#17
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
#18
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
#19
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
#20
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
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