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Peg filgrastim

Nagham N Hindi, Mohammad I Saleh
Neutropenia is a hematologic disorder commonly reported in patients with chronic hepatitis C virus (HCV) infection treated with pegylated interferon alfa-2a (PEG-IFN α-2a). The objective of the present project is to identify patient characteristics associated with neutropenia in hepatitis C patients. Demographic, clinical, and genetic data from 715 patients with chronic HCV infection treated with PEG-IFN α-2a and ribavirin. The outcome variable was the development of grade 3 or 4 neutropenia, defined as the decrease in neutrophil counts below 1x109 /L anytime during study...
March 25, 2018: Clinical and Experimental Pharmacology & Physiology
Jeungwoon Hong, Byoungju Lee, Kwanyub Kang, Seung-Hoon Lee, Jaehwan Ryu, Gangsoo Jung, Jaetaek Oh, Eui-Cheol Jo, Chan-Wha Kim
We describe the characterisation of a novel monoPEGylated recombinant human granulocyte colony-stimulating factor analogue, pegteograstim (Neulapeg), prepared by site-specific 20 kDa maleimide-PEG conjugation. An additional cysteine was inserted between Gly136 and Ala137 of filgrastim (methionyl human granulocyte colony-stimulating factor) for site-specific PEGylation, and Cys18 of filgrastim was replaced with Ser18 to prevent unwanted PEGylation. Pegteograstim was produced by Escherichia coli and purified by cation exchange chromatography, and its structural, physicochemical, biological and immunological properties were investigated...
October 26, 2017: Biologicals: Journal of the International Association of Biological Standardization
Robert de W Marsh, Mark S Talamonti, Marshall S Baker, Mitchell Posner, Kevin Roggin, Jeffrey Matthews, Daniel Catenacci, Mark Kozloff, Blase Polite, Michele Britto, Chi Wang, Hedy Kindler
BACKGROUND AND OBJECTIVES: Surgery followed by gemcitabine and/or a fluoropyrimidine is standard therapy for resectable PDAC. mFOLFIRINOX (oxaliplatin 85 mg/m(2) , irinotecan 180 mg/m(2) , leucovorin 400 mg/m(2) Day 1, 5-FU 2400 mg/m(2)  × 48 h IV, peg-filgrastim 6 mg SQ day 3, every 14 days) has substantial activity in metastatic PDAC. We wished to determine the tolerability/efficacy of peri-operative mFOLFIRINOX in resectable PDAC. METHODS: Patients with resectable PDAC (ECOG PS 0/1) received four cycles of mFOLFIRINOX pre- and post-surgery...
October 16, 2017: Journal of Surgical Oncology
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
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...
May 10, 2017: Journal of Pharmaceutical and Biomedical Analysis
Tara Arvedson, James O'Kelly, Bing-Bing Yang
Filgrastim, a recombinant methionyl human granulocyte colony-stimulating factor (G-CSF) (r-metHuG-CSF), is efficacious in stimulating neutrophil production and maturation to prevent febrile neutropenia (FN) in response to chemotherapy. Because of its relatively short circulating half-life, daily filgrastim injections are required to stimulate neutrophil recovery. In an effort to develop a long-acting form of filgrastim that was as safe and efficacious as filgrastim but had a longer in vivo residence time, a number of strategies were considered...
June 2015: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Junichi Kaneko, Yasuhiko Sugawara, Takamune Yamaguchi, Nobuhiro Harada, Nobuhisa Akamatsu, Takeaki Ishizawa, Taku Aoki, Yoshihiro Sakamoto, Kiyoshi Hasegawa, Sumihito Tamura, Tomohiro Tanaka, Norihiro Kokudo
Telaprevir (TVR), a direct -acting protease inhibitor, was recently reported to improve treatment efficacy when used in combination with peg-interferon (PEG-IFN) and ribavirin (RBV) as triple therapy for HCV in non-transplant patients. The aim of the present study was to investigate the feasibility of TVR-based triple therapy among Japanese living donor liver transplant (LDLT) recipients who had been resistant to dual treatment with PEG-IFN and RBV. Among 133 HCV-positive LDLT recipients, 8 null responders during or after dual treatment with PEG-IFN and RBV were finally indicated for TVR-based triple therapy after treatment...
December 2014: Bioscience Trends
Veronica Bernabucci, Alessia Ciancio, Salvatore Petta, Aimilia Karampatou, Laura Turco, Silvia Strona, Rosina Critelli, Paola Todesca, Caterina Cerami, Caterina Sagnelli, Mario Rizzetto, Calogero Cammà, Erica Villa
AIM: To investigate the safety/efficacy of Boceprevir-based triple therapy in hepatitis C virus (HCV)-G1 menopausal women who were historic relapsers, partial-responders and null-responders. METHODS: In this single-assignment, unblinded study, we treated fifty-six menopausal women with HCV-G1, 46% F3-F4, and previous PEG-α/RBV failure (7% null, 41% non-responder, and 52% relapser) with 4 wk lead-in with PEG-IFNα2b/RBV followed by PEG-IFNα2b/RBV+Boceprevir for 32 wk, with an additional 12 wk of PEG-IFN-α-2b/RBV if patients were HCV-RNA-positive by week 8...
November 28, 2014: World Journal of Gastroenterology: WJG
Meenu Wadhwa, Chris Bird, Thomas Dougall, Peter Rigsby, Adrian Bristow, Robin Thorpe
We assessed the feasibility of developing a suitable international reference standard for determination of in vitro biological activity of human sequence recombinant PEG-G-CSF products with a 20kD linear PEG linked to the N-terminal methionyl residue of G-CSF (INN Filgrastim), produced using a conjugation process and coupling chemistry similar to that employed for the lead PEGfilgrastim product. Based on initial data which showed that the current WHO 2nd international standard, IS for G-CSF (09/136) or alternatively, a PEG-G-CSF standard with a unitage traceable to the G-CSF IS may potentially serve as the IS for PEG-G-CSF products, two candidate preparations of PEG-G-CSF were formulated and lyophilized at NIBSC...
January 2015: Journal of Immunological Methods
Kelly Cristhian Lima Oliveira, Emili de Oliveira Bortolon Cardoso, Suzana Carla Pereira de Souza, Flávia Souza Machado, Carlos Eduardo Alves Zangirolami, Alecsandro Moreira, Giovanni Faria Silva, Cássio Vieira de Oliveira
The use of triple therapy for hepatitis C not only increases the rate of sustained virological responses compared with the use of only interferon and ribavirin (RBV) but also leads to an increased number of side effects. The subject of this study was a 53-year-old male who was cirrhotic with hepatitis C virus genotype 1 A and was a previous null non-responder. We initially attempted retreatment with boceprevir (BOC), Peg-interferon and RBV, and a decrease in viral load was observed in the 8(th) week. In week 12, he presented with disorientation, flapping, fever, tachypnea, arterial hypotension and tachycardia...
June 27, 2014: World Journal of Hepatology
S Fine, M Koo, T Gill, M Marin, M Poulin-Costello, R Barron, N Mittmann
BACKGROUND: Data on real-life utilization of granulocyte colony-stimulating factors (g-csfs) in Canada are limited. The objective of the present study was to describe the reasons for, and the patterns of, g-csf use in selected outpatient oncology clinics in Ontario and Quebec. METHODS: In a retrospective longitudinal cohort study, a review of medical records from 9 Canadian oncology clinics identified patients being prescribed filgrastim (fil) and pegfilgrastim (peg)...
April 2014: Current Oncology
Paul Y Kwo, Marwan Ghabril, Marco A Lacerda, Alfred Joseph Tector, Jonathan A Fridell, Rodrigo Vianna
INTRODUCTION: Aggressive recurrence of hepatitis C remains problematic post-orthotopic liver transplant (OLT). There are limited data on treatment of HCV infection with telaprevir/boceprevir therapy with peginterferon/ribavirin (PR) post-OLT. AIM: To review our experience with telaprevir addition to peginterferon/ribavirin in treatment of aggressive hepatitis C in null responders to PR post-OLT. METHODS: Adult patients with recurrent HCV infection post-OLT with null response to peginterferon/ribavirin for 12 wk (<2 log reduction) received four-wk lead-in PEG-IFN alfa-2b (1...
June 2014: Clinical Transplantation
Massimo Martino, Daniele Laszlo, Francesco Lanza
INTRODUCTION: Peg-filgrastim (PEG-FIL), a polyethylene glycol-conjugated form of granulocyte colony-stimulating factor (G-CSF), has been introduced in clinical practice and is effective in shortening the time of neutropenia after cytotoxic chemotherapy. G-CSF has emerged as the preferred cytokine for hematopoietic progenitor cells' (HPC) mobilization. Nevertheless, data on the ability of PEG-FIL in this field have been published. AREAS COVERED: We review publications in the field with the goal of providing an overview of this approach...
June 2014: Expert Opinion on Biological Therapy
Pashtoon Murtaza Kasi, Mrinal M Patnaik, Prema P Peethambaram
Pegfilgrastim (Neulasta) is a recombinant filgrastim (human granulocyte colony-stimulating factor (G-CSF)) attached to a polyethylene glycol (PEG) molecule and is given as part of chemotherapy regimens that are associated with significant myelosuppression and risk for febrile neutropenia. Prescribing information available on manufacturer's website for the drug warns us about possible severe sickle cell crises related to the medication but does not report the actual incidence or the use in patients with sickle cell trait...
2013: Case Reports in Hematology
Maurizio Rupolo, Arben Lleshi, Bruno Cacopardo, Mariagrazia Michieli, Massimiliano Berretta
The 60% of tumors affected patients >65years of age and the future previsions are considering an amount of 70% after 2030. Elderly Patients presents multiple comorbidity, polipharmacy, and disability. Geriatric assessment helps physicians to take the best therapeutic decisions. Clinical conditions influence efficacy and tolerability of chemotherapy. Prophylactic use of G-CSF after chemotherapy lowers the rate and length of severe neutropenia , and decreases the episodes of febrile neutropenia. Anemia is a hematologic condition associated with ageing , but is frequently associated to concomitant chronic disease...
November 2013: Anti-cancer Agents in Medicinal Chemistry
Paul Shaughnessy, Nelson Chao, Jamie Shapiro, Kent Walters, John McCarty, Sunil Abhyankar, Sepideh Shayani, Pieter Helmons, Helen Leather, Amy Pazzalia, Simon Pickard
Adequate hematopoietic stem cell (HSC) mobilization and collection is required prior to proceeding with high dose chemotherapy and autologous hematopoietic stem cell transplant. Cytokines such as G-CSF, GM-CSF, and peg-filgrastim, alone or in combination with plerixafor, and after chemotherapy have been used to mobilize HSCs. Studies have shown that the efficiency of HSC mobilization and collection may vary when different methods of mobilization are used. No studies have shown that survival is significantly affected by the method of mobilization, but some studies have suggested that cost and resource utilization may be different between different mobilization techniques...
September 2013: Biology of Blood and Marrow Transplantation
Ivonete Silva, Roberto Carvalho Filho, Ana Cristina Feldner, Iandra Zaros, Antonio Eduardo Silva, Maria Lucia Ferraz
INTRODUCTION: Treatment of genotype 1 chronic hepatitis C in elderly patients has been associated with low rates of a sustained virological response (SVR), but the reasons are unclear. OBJECTIVE: To determine the SVR rate in patients ≥ 60 years with genotype 1 chronic hepatitis C treated with Peg-IFN and ribavirin, and to identify risk factors related to treatment response in this specific group of patients. Material and methods. Patients were divided into < 60 years (non-elderly) and ≥60 years (elderly) and were compared regarding clinical, laboratory and histological characteristics and response to treatment...
May 2013: Annals of Hepatology
I A Puchkov, N V Kononova, A I Bobruskin, D I Bairamashvili, V A Mart'ianov, A M Shuster
In order to create an active pharmaceutical substance of the drug with prolonged action the modification of recombinant human granulocyte colony-stimulating factor GCSF (filgrastim) with polyethylene glycol (PEG, M 21.5 kDa) was conducted. A method for preparation of PEG-filgrastim designed for the development and scaling-up of the technological process of production was described. Modification of proteins with PEG was performed by selective covalent attachment of the molecule alpha-methyl-PEG-propionaldehyde to the alpha-amino group of the N-terminal methionine amino acid residue of the recombinant GCSF...
September 2012: Bioorganicheskaia Khimiia
Saveria Capria, Silvia Maria Trisolini, Clara Minotti, Caterina Stefanizzi, Luisa Cardarelli, Claudio Cartoni, Daniela Diverio, Maria Stefania De Propris, Marco Mancini, Alessandra Micozzi, Robin Foà, Giovanna Meloni
Long-term survival of relapsed/refractory acute myeloid leukemia (AML) remains a major problem, particularly in patients not eligible for transplantation.We hereby evaluated the feasibility and efficacy of adding Gemtuzumab Ozogamicin to salvage chemotherapy (Ara-C, Idarubicine, Peg-Filgrastim) in relapsed/refractory AML. The main endpoints were: the rate of complete remissions (CR) and the proportion of patients capable of undergoing a stem cell transplant.Fourty-two patients were enrolled. The overall CR rate was 76% and no induction deaths were reported...
2012: Mediterranean Journal of Hematology and Infectious Diseases
Giuseppe Di Lorenzo, Carmine DʼAniello, Carlo Buonerba, Piera Federico, Pasquale Rescigno, Livio Puglia, Matteo Ferro, Davide Bosso, Carla Cavaliere, Giovannella Palmieri, Guru Sonpavde, Sabino De Placido
To determine the impact of prophylaxis with granulocyte-colony stimulating growth factor (G-CSF) on the risk of febrile neutropenia in a cohort of patients enrolled at the University Federico II of Naples and treated with cabazitaxel for metastatic castration-resistant prostate cancer (mCRPC). We carried out a retrospective review of prospectively collected data of patients enrolled at our institution in a compassionate-use programme with cabazitaxel, aimed at providing early access to the drug before its commercial availability in mCRPC patients...
January 2013: Anti-cancer Drugs
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