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https://www.readbyqxmd.com/read/27920647/febrile-neutropenia-with-thrombocytopenia-after-infliximab-induction-in-a-patient-with-ulcerative-colitis
#1
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
#2
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
#3
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...
November 19, 2016: 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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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...
October 6, 2016: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/27695174/acute-promyelocytic-leukemia-after-renal-transplant-and-filgrastim-treatment-for-neutropenia
#15
Jaime A Campbell, John R Krause
Prolonged immunosuppression in solid organ transplant recipients has been considered a risk for developing opportunistic infections and malignancies. Acute leukemia is a rare complication. We report a case of acute promyelocytic leukemia (APL) (FAB M3) after cadaveric renal transplant for focal segmental glomerulosclerosis in a 24-year-old woman. Her immunosuppressive therapy included tacrolimus, mycophenolate mofetil, and prednisone. Approximately 2 years after transplant, she became pancytopenic, prompting administration of filgrastim...
October 2016: Proceedings of the Baylor University Medical Center
https://www.readbyqxmd.com/read/27688102/partner-an-open-label-randomized-phase-2-study-of-docetaxel-cisplatin-chemotherapy-with-or-without-panitumumab-as-first-line-treatment-for-recurrent-or-metastatic-squamous-cell-carcinoma-of-the-head-and-neck
#16
Lori J Wirth, Shaker Dakhil, Gabriela Kornek, Rita Axelrod, Douglas Adkins, Shubham Pant, Paul O'Brien, Philip R Debruyne, Kelly S Oliner, Jun Dong, Swami Murugappan
OBJECTIVE: This phase 2 estimation study evaluated docetaxel/cisplatin with/without panitumumab, an anti-epidermal growth factor receptor monoclonal antibody, as first-line therapy for recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN). PATIENTS AND METHODS: Randomized patients received docetaxel/cisplatin (75mg/m(2) each) with/without panitumumab (9mg/kg) in 21-day cycles. Patients randomized to panitumumab+chemotherapy could continue panitumumab monotherapy after completing six chemotherapy cycles without progression; patients randomized to chemotherapy alone could receive second-line panitumumab after progression...
October 2016: Oral Oncology
https://www.readbyqxmd.com/read/27668063/zarxio-filgrastim-sndz-first-biosimilar-approved-in-the-united-states
#17
Lisa A Raedler
No abstract text is available yet for this article.
March 2016: American Health & Drug Benefits
https://www.readbyqxmd.com/read/27649817/feasibility-and-kinetics-of-cd34-hematopoietic-progenitor-cell-mobilization-in-response-to-a-single-administration-of-docetaxel-chemotherapy-and-pegfilgrastim-in-a-contemporary-cohort-of-patients-with-metastatic-breast-cancer
#18
Harminder Takhar, Anna Rachelle Mislang, Nimit Singhal, Michael P Brown
AIM: Autologous hematopoietic stem cell transplantation (auto-HSCT) remains an experimental therapy for metastatic breast cancer (MBC) and there is no established protocol for cluster of differentiation 34(+) (CD34(+) ) hematopoietic progenitor cell (HPC) mobilization with historic studies using growth factors with or without chemotherapy. This study describes the feasibility and kinetics of CD34(+) HPC mobilization following a single administration of docetaxel and the pegylated form of recombinant human granulocyte colony-stimulating factor analogue filgrastim (pegfilgrastim)...
September 21, 2016: Asia-Pacific Journal of Clinical Oncology
https://www.readbyqxmd.com/read/27633122/healthy-donor-hematopoietic-stem-cell-mobilization-with-biosimilar-granulocyte-colony-stimulating-factor-safety-efficacy-and-graft-performance
#19
Petra Becker, Arnd Schwebig, Susanne Brauninger, Heike Bialleck, Beate Luxembourg, Miriam Schulz, Chrysanthi Tsamadou, Markus Wiesneth, Peter Reinhardt, Joannis Mytilineos, Christian Seidl, Sreekanth Gattu, Natalia Kaliakina, Pritibha Singh, Hubert Schrezenmeier, Erhard Seifried, Halvard Bonig
BACKGROUND: Biosimilar granulocyte-colony-stimulating factors (G-CSFs) have been available in the European Union since 2008, and Sandoz' biosimilar filgrastim was approved in the United States in March 2015 for all of the reference product's indications except acute radiation syndrome. Biosimilar G-CSFs have been largely embraced by the medical community, except for some reservations about healthy-donor stem cell mobilization, for which use outside of clinical studies was cautioned against by some members of the scientific community...
September 16, 2016: Transfusion
https://www.readbyqxmd.com/read/27623036/mexican-biosimilar-filgrastim-for-autologous-hematopoietic-stem-cell-mobilization-and-transplantation
#20
Mónica León-González, Andrés A León-Peña, María Fernanda Vallejo-VIllalobos, Ana Karen Núñez-Cortés, Alejandro Ruiz-Argüelles, Guillermo J Ruiz-Argüelles
BACKGROUND: Following the release of the initial presentation of filgrastim (granulocyte colony-stimulating factor), several biosimilars have been developed worldwide. OBJECTIVE: To study the efficacy of a Mexican biosimilar granulocyte colony-stimulating factor in a single transplant center. METHODS: In a group of 19 consecutive patients with multiple sclerosis given autografts, we employed granulocyte colony-stimulating factors to mobilize stem cells from the bone marrow to the peripheral blood, either the original granulocyte colony-stimulating factor (n = 10) or a Mexican granulocyte colony-stimulating factor biosimilar (n = 9)...
July 2016: Revista de Investigación Clínica; Organo del Hospital de Enfermedades de la Nutrición
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