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https://www.readbyqxmd.com/read/28722494/cost-efficiency-analyses-for-the-us-of-biosimilar-filgrastim-sndz-reference-filgrastim-pegfilgrastim-and-pegfilgrastim-with-on-body-injector-in-the-prophylaxis-of-chemotherapy-induced-febrile-neutropenia
#1
Ali McBride, Kim Campbell, Mohan Bikkina, Karen MacDonald, Ivo Abraham, Sanjeev Balu
AIMS: Guidelines recommend prophylaxis with granulocyte colony-stimulating factor for chemotherapy-induced (febrile) neutropenia (CIN/FN) based on regimen myelotoxicity and patient-related risk factors. Our aim was to conduct a cost-efficiency analysis for the US of the direct acquisition and administration costs of the recently approved biosimilar filgrastim-sndz (Zarxio® EP2006) with reference filgrastim (Neupogen(®)), pegfilgrastim (Neulasta(®)), and pegfilgrastim injection device (Neulasta Onpro(®); hereafter pegfilgrastim-injector) for CIN/FN prophylaxis...
July 19, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28653421/comparison-of-biosimilar-filgrastim-originator-filgrastim-and-lenograstim-for-autologous-stem-cell-mobilization-in-patients-with-multiple-myeloma
#2
Katharina Lisenko, Marc-Andrea Baertsch, Renate Meiser, Petra Pavel, Thomas Bruckner, Mark Kriegsmann, Anita Schmitt, Mathias Witzens-Harig, Anthony D Ho, Jens Hillengass, Patrick Wuchter
BACKGROUND: Granulocyte-colony-stimulating factor (G-CSF) originators such as filgrastim (Neupogen) and lenograstim (Granocyte) are widely used for peripheral blood stem cell (PBSC) mobilization. In recent years, biosimilar agents have been approved for the same indications. The aim of this retrospective study was to compare the mobilization efficiency of the three G-CSF variants originator filgrastim, lenograstim, and the biosimilar Filgrastim Hexal in a homogeneous group of multiple myeloma (MM) patients in first-line therapy...
June 26, 2017: Transfusion
https://www.readbyqxmd.com/read/28642700/pricing-and-reimbursement-of-biosimilars-in-central-and-eastern-european-countries
#3
Paweł Kawalec, Ewa Stawowczyk, Tomas Tesar, Jana Skoupa, Adina Turcu-Stiolica, Maria Dimitrova, Guenka I Petrova, Zinta Rugaja, Agnes Männik, Andras Harsanyi, Pero Draganic
Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries. Methods: A questionnaire-based survey was conducted between November 2016 and January 2017 among experts from the following CEE countries: Bulgaria, Czech Republic, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. The requirements for the pricing and reimbursement of biosimilars were reviewed for each country...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28622961/zoh%C3%A3-a-prospective-study-of-the-use-of-biosimilar-filgrastim-zarzio-in-clinical-practice-in-patients-treated-with-chemotherapy-for-lymphoid-malignancies
#4
Gandhi Laurent Damaj, Omar Benbrahim, Maya Hacini, Inna Voronina, Khaled Benabed, Ravaka-Fatoma Soumoudronga, Isabelle Gasnereau, Corinne Haioun, Philippe Solal-Céligny
BACKGROUND: The ZOHé study was a prospective, observational, multicenter study in France to assess use of biosimilar filgrastim Zarzio in routine clinical practice in patients undergoing neutropenia-inducing chemotherapy. PATIENTS AND METHODS: Patients ≥ 18 years undergoing chemotherapy for a malignant disease and with a first prescription for Zarzio were enrolled in 2 cohorts: solid tumor (1174 patients) or hematological malignancy (633 patients); the latter is reported here...
June 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/28619479/a-demonstration-of-analytical-similarity-comparing-a-proposed-biosimilar-pegfilgrastim-and-reference-pegfilgrastim
#5
Stephen Brokx, Louise Scrocchi, Nirmesh Shah, Jason Dowd
BACKGROUND: Recombinant human granulocyte-colony stimulating factor (G-CSF, filgrastim) is used primarily to reduce incidence and duration of severe neutropenia and its associated complications in cancer patients that have received a chemotherapy regimen. The pegylated form of filgrastim, "pegfilgrastim", is a long-acting form that requires only a once-per-cycle administration for the management of chemotherapy-induced neutropenia. Apobiologix, a division of ApoPharma USA, Inc., and Intas Pharmaceuticals Limited have co-developed a proposed pegfilgrastim biosimilar to US-licensed pegfilgrastim...
June 12, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28614980/meta-analysis-and-indirect-treatment-comparison-of-lipegfilgrastim-with-pegfilgrastim-and-filgrastim-for-the-reduction-of-chemotherapy-induced-neutropenia-related-events
#6
T Christopher Bond, Erika Szabo, Susan Gabriel, Jean Klastersky, Omar Tomey, Udo Mueller, Lee Schwartzberg, Boxiong Tang
Background Granulocyte colony-stimulating factors are effective at reducing the risk and duration of neutropenia. The current meta-analysis compared the neutropenia-related efficacy and safety of lipegfilgrastim to those of pegfilgrastim and filgrastim. Methods Embase was searched for trials examining the efficacy/safety of lipegfilgrastim, pegfilgrastim, or filgrastim. Outcomes included febrile neutropenia, severe neutropenia, duration of severe neutropenia, time to recovery of absolute neutrophil count, and incidence of bone pain...
January 1, 2017: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/28612945/comparative-study-of-the-number-of-report-and-time-to-onset-of-the-reported-adverse-event-between-the-biosimilars-and-the-originator-of-filgrastim
#7
Tetsu Kobayashi, Izumi Kamada, Junko Komura, Satoshi Toyoshima, Akiko Ishii-Watabe
PURPOSE: The objective of this study is to specify the most reported adverse events as preferred terms (PTs) and to compare the reported adverse events about some properties including the number of report and time-to-onset (TTO) distribution of the originator of filgrastim Neupogen® and its biosimilars in Europe, using VigiBase®. METHODS: We identified the biosimilar which was reported as the suspected drug in more than 100 individual case safety reports in Europe...
June 14, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28597691/safety-and-efficacy-of-pegfilgrastim-when-given-less-than-14-days-before-the-next-chemotherapy-cycle-retrospective-review-of-every-14-day-chemotherapy-regimen-containing-5-fu-continuous-infusion
#8
Kofi N Donkor, Julie H Selim, Ariani Waworuntu, Kelsey Lewis
BACKGROUND: Pegfilgrastim should not be given <14 days from the next chemotherapy because of concerns for cytopenias. Some clinicians are prescribing pegfilgrastim to be given <14 days in patients receiving 5-fluorouracil continuous infusion (5-FUCI) regimens. OBJECTIVE: To determine the effectiveness and safety of pegfilgrastim administered <14 days from the next chemotherapy in patients receiving 5-FUCI administered >46 hours. METHODS: Single-institution retrospective cohort study of patients who received 5-FUCI administered >46 hours from June 2013 to December 2015...
June 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28587560/effectiveness-of-originator-neupogen-and-biosimilar-zarzio-filgrastim-in-autologous-peripheral-blood-stem-cell-mobilization-in-adults-with-acute-myeloid-leukemia-a-single-center-retrospective-study
#9
Vincenzo Nasillo, Ambra Paolini, Giovanni Riva, Monica Morselli, Leonardo Potenza, Valeria Coluccio, Monica Maccaferri, Elisabetta Colaci, Valeria Fantuzzi, Andrea Messerotti, Laura Arletti, Valeria Pioli, Elisabetta Lugli, Andrea Gilioli, Chiara Quadrelli, Patrizia Zucchini, Daniela Vallerini, Ivana Lagreca, Patrizia Barozzi, Angela Cuoghi, Paola Bresciani, Roberto Marasca, Maria Teresa Mariano, Giovanni Ceccherelli, Patrizia Comoli, Daniele Campioli, Tommaso Trenti, Franco Narni, Mario Luppi, Fabio Forghieri
No abstract text is available yet for this article.
June 7, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28559645/comorbidity-between-htlv-1-associated-adult-t-cell-lymphoma-leukemia-and-verrucous-carcinoma-a-case-report
#10
Miller Valencia, Luis Moreno
BACKGROUND: Adult T-cell Leukemia/Lymphoma (ATLL) is classified as a peripheral CD4+ T-cell neoplasm caused by the human T-cell lymphotropic virus type 1 (HTLV-1). Typical symptoms are associated with leukemic infiltration; however, atypical and exaggerated manifestations of verrucous carcinoma have also been described. CASE REPORT: We present here the case of a patient with multiple skin lesions, ischemic necrosis in the hallux and lymphadenopathies. Biopsies were taken, which showed verrucous epidermal carcinoma and cutaneous lymphoma...
March 30, 2017: Colombia Médica: CM
https://www.readbyqxmd.com/read/28554533/therapeutic-use-of-filgrastim-for-established-febrile-neutropenia-is-cost-effective-among-patients-with-solid-tumors-and-lymphomas
#11
Xiao Jun Wang, Wei Xiang Tong, Alexandre Chan
PURPOSE: With the emergence of biosimilar filgrastim to the market, there is a gradual decrease in the listed price of the originator product of filgrastim over the years, and this could have an impact on the cost-effectiveness of filgrastim in the treatment of febrile neutropenia (FN). A cost-effectiveness analysis would allow clinicians to make informed decision when considering the therapeutic filgrastim among low-risk FN patients. This study aims to evaluate the cost-effectiveness of adding therapeutic filgrastim to antibiotics in the treatment of established FN among patients with solid tumors and lymphomas...
May 26, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28549110/thoracic-aortitis-and-aortic-dissection-following-pegfilgrastim-administration
#12
Yuki Sato, Shuichiro Kaji, Hiroyuki Ueda, Keisuke Tomii
The patient was a 67-year-old woman with a history of advanced lung adenocarcinoma. Eight days after pegfilgrastim administration, her computed tomography scan revealed thickened bilateral common carotid arteries and thoracic aorta, which led to the diagnosis of pegfilgrastim-associated aortitis. Thirty-six days after pegfilgrastim administration, asymptomatic Stanford type B aortic dissection was detected. Her serum biomarker analysis suggested that interleukin-6 might be involved in the pathogenesis. Physicians should be aware of these adverse effects of filgrastim...
May 26, 2017: European Journal of Cardio-thoracic Surgery
https://www.readbyqxmd.com/read/28527129/efficacy-and-safety-of-plerixafor-for-the-mobilization-collection-of-peripheral-hematopoietic-stem-cells-for-autologous-transplantation-in-japanese-patients-with-multiple-myeloma
#13
Masaki Ri, Kosei Matsue, Kazutaka Sunami, Chihiro Shimazaki, Akio Hayashi, Yoshinori Sunaga, Toru Sasaki, Kenshi Suzuki
To evaluate the efficacy and safety of plerixafor for the mobilization/collection of peripheral hematopoietic stem cells (HSCs) for autologous transplantation in Japanese patients with multiple myeloma (MM). In a randomized study, patients received G-CSF (filgrastim, 400 µg/m(2)/day) for 4 days prior to the first dose of plerixafor. Starting on Day 4 evening and for up to 4 days, patients received either plerixafor (240 µg/kg/day) + G-CSF group (PG group) or G-CSF alone (G group). Daily apheresis started on Day 5 for up to 4 days, or until ≥6 × 10(6) CD34+ cells/kg were collected...
May 19, 2017: International Journal of Hematology
https://www.readbyqxmd.com/read/28485020/pegylated-granulocyte-colony-stimulating-factor-versus-non-pegylated-granulocyte-colony-stimulating-factor-for-peripheral-blood-stem-cell-mobilization-a-systematic-review-and-meta-analysis
#14
Jew W Kuan, Anselm T Su, Chooi F Leong
Granulocyte-colony stimulating factor (G-CSF) mobilizes and increases the amount of hematopoietic stem cells in peripheral blood, enabling its harvest by few apheresis procedures. The pegylated G-CSF has longer half-life and is given once only, which is more comfortable for patients, whereas the non-pegylated requires multiple daily injection because of its short half-life. We summarized results of randomized trials comparing the efficacy and safety of pegylated and non-pegylated G-CSF for peripheral blood stem cell mobilization...
May 9, 2017: Journal of Clinical Apheresis
https://www.readbyqxmd.com/read/28454057/application-of-2d-nmr-with-room-temperature-nmr-probes-for-the-assessment-of-the-higher-order-structure-of-filgrastim
#15
Robert G Brinson, Houman Ghasriani, Derek J Hodgson, Kristie M Adams, Ian McEwen, Darón I Freedberg, Kang Chen, David A Keire, Yves Aubin, John P Marino
The higher order structure (HOS) of biotherapeutics is a critical quality attribute that can be evaluated by nuclear magnetic resonance (NMR) spectroscopy at atomic resolution. NMR spectral mapping of HOS can be used to establish HOS consistency of a biologic across manufacturing changes or to compare a biosimilar to an innovator reference product. A previous inter-laboratory study performed using filgrastim drug products demonstrated that two-dimensional (2D)-NMR (1)H(N)-(15)N(H) heteronuclear correlation spectroscopy is a highly robust and precise method for mapping the HOS of biologic drugs at natural abundance using high sensitivity NMR 'cold probes...
April 4, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28453180/a-novel-homozygous-vps45-p-p468l-mutation-leading-to-severe-congenital-neutropenia-with-myelofibrosis
#16
Rikin K Shah, Mary Munson, Klaas J Wierenga, Hanumantha R Pokala, Peter E Newburger, David Crawford
VPS45-associated severe congenital neutropenia (SCN) is a rare disorder characterized by life-threating infections, neutropenia, neutrophil and platelet dysfunction, poor response to filgrastim, and myelofibrosis with extramedullary hematopoiesis. We present a patient with SCN due to a homozygous c.1403C>T (p.P468L) mutation in VPS45, critical regulator of SNARE-dependent membrane fusion. Structural modeling indicates that P468, like the T224 and E238 residues affected by previously reported mutations, cluster in a VPS45 "hinge" region, indicating its critical role in membrane fusion and VPS45-associated SCN...
April 28, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/28439700/filgrastim-alone-versus-pegylated-filgrastim-alone-for-autologous-peripheral-blood-stem-cells-mobilization-in-newly-diagnosed-multiple-myeloma-patients
#17
Barbara Skopec, Matevz Skerget, Darja Zontar, Vesna Zadnik, Samo Zver
BACKGROUND: Autologous hematopoietic stem cell transplantation (aHSCT) is the recommended standard upfront treatment for transplant eligible myeloma patients. Considering possible complications related to chemotherapy-cytokine mobilization, cytokine-alone mobilization is often used. We compared mobilization with filgrastim alone to pegfilgrastim alone in newly diagnosed myeloma patients after induction treatment with bortezomib and dexamethasone. The comparison was made between peripheral blood stem cell (PBSC) yields, number of apheresis, hematopoietic stem cell subsets, and time to neutrophil and platelet engraftment after aHSCT...
April 24, 2017: Wiener Klinische Wochenschrift
https://www.readbyqxmd.com/read/28438855/the-effectiveness-of-febrile-neutropenia-prophylaxis-with-lipegfilgrastim-in-routine-clinical-practice
#18
REVIEW
Lubos Holubec, Jiri Polivka, Lenka Lisnerova, Tereza Kubikova, Martin Safanda
Febrile neutropenia (FN) is a common and potentially fatal complication of anticancer treatment, particularly in patients receiving myelosuppressive chemotherapy. It has been shown that prophylaxis with granulocyte colony-stimulating factor (G-CSF), especially its pegylated forms, significantly reduces the incidence of FN, the likelihood of chemotherapy dose intensity reduction and, also, the number of hospitalizations due to FN. This review discusses currently published results from clinical trials dealing with FN prophylaxis in routine clinical practice in patients with solid tumors and myeloproliferative malignancies with a focus on lipegfilgrastim, which is the newest modification of the original molecule filgrastim...
May 2017: In Vivo
https://www.readbyqxmd.com/read/28362168/impact-of-abbreviated-filgrastim-schedule-on-survival-and-hematopoietic-recovery-after-irradiation-in-four-mouse-strains-with-different-radiosensitivity
#19
Merriline Satyamitra, Vidya P Kumar, Shukla Biswas, Lynnette Cary, Leonora Dickson, Srinivasan Venkataraman, Sanchita P Ghosh
Filgrastim (Neupogen(®), granulocyte-colony stimulating factor) is among the few countermeasures recommended for management of patients in the event of lethal total-body irradiation. Despite the plethora of studies using filgrastim as a radiation countermeasure, relatively little is known about the optimal dose schedule of filgrastim to mitigate radiation lethality. We evaluated the efficacy of filgrastim in improving 30-day survival of CD2F1 mice irradiated with a lethal dose (LD70/30) in the AFRRI cobalt-60 facility...
June 2017: Radiation Research
https://www.readbyqxmd.com/read/28353170/impact-of-guidance-on-the-prescription-patterns-of-g-csfs-for-the-prevention-of-febrile-neutropenia-following-anticancer-chemotherapy-a-population-based-utilization-study-in-the-lazio-region
#20
Francesco Trotta, Flavia Mayer, Alessandra Mecozzi, Laura Amato, Antonio Addis
BACKGROUND: Current guidelines recommend prophylaxis with granulocyte colony-stimulating factors (G-CSFs) for patients with cancer who are at greater risk of febrile neutropenia (FN) while receiving chemotherapy. G-CSF biosimilars are available and represent a savings opportunity; however, their uptake has thus far been low. OBJECTIVE: Our objective was to evaluate prescribing patterns for G-CSFs in the prevention of chemotherapy-related FN and to evaluate the impact of regional guidance on G-CSF prescription...
April 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
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