Short and long-term safety of lenograstim administration in healthy peripheral haematopoietic progenitor cell donors: a single centre experience

“…İran'dan yapılan bir çalışmada, hastaların %5'inde yorgunluk, %3'ünde baş ağrısı bildirilmiş, hastaların yakınmaları bir hafta içerisinde düzelmiştir (13) . Erişkinlerin aksine çocukluk döneminde kemik ağrısı sık görülmemektedir (1,13,14) . G-CSF'in çok ender olgu bildirimleri şeklinde olan ama ciddi yan etkileri dalak ruptürü, akciğer hasarı, rabdomyoliz ve otoimmüni-tedir (15)(16)(17)(18) .…”

Section: Kök Hücre Mobilizasyonu Ve Toplanması Sırasında Gelişebilen unclassified

Peripheric Stem Cell Collection Practices At Childhood

Kazancı¹,

Bayhan²

2018

BUCH

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“…La sicurezza dei diversi G-CSF si declina in due differenti tipologie: la sicurezza a breve e a lungo termine [21][22][23][24][25][26][27]. Per quanto riguarda la sicurezza a breve termine, i diversi G-CSF sono generalmente ben tollerati.…”

Section: Sicurezzaunclassified

“…Tra questi, lo studio di Martino et al condotto per valutare gli effetti collaterali a breve e a lungo termine del G-CSF identico all'umano, in cui sono stati valutati 184 donatori sani sottoposti al trattamento con lenograstim [27]. Il monitoraggio annuale degli eventi a lungo termine è stato effettuato per una media di 62 mesi e nessuno dei soggetti ha sviluppato alterazioni ematologiche, confermando il profilo di sicurezza della stimolazione con tale farmaco [27]. Dati simili sono riportati in un' esperienza monocentrica condotta su 3.928 donatori sani e durata 12 anni [23].…”

Section: Sicurezzaunclassified

Appropriate administration of Granulocyte-Colony Stimulating Factors

Rosti¹

2012

RHC

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Chemotherapy-induced febrile neutropenia is a potentially fatal complication of cancer treatment and is also the main reason of dose-reduction and/or delay of chemotherapy regimen. Prophylaxis with G-CSF is applicable to reduce the risk of chemotherapy-induced neutropenia. Two molecules of recombinant G-CSF are available for clinical use: lenograstim, identical to human native G-CSF, that is derived from mammalian cells and filgrastim, different to human native G-CSF, expressed in E. coli and commercialized in normal form and pegilated long-acting form. Neutrophil morphology and expected defense functions are modified by treatment with filgrastim, while they are not affected by lenograstim. These functionality differences observed in vitro are recently confirmed in a clinical trial that shows a lower incidence of febrile episodes with lenograstim compared to filgrastim in presence of G-CSF induced neutrophils. The long-term safety of lenograstim was supported by the results of a prospective, longer-term study involving almost 4,000 healthy donors. Another important question is the respect of timing of administration of G-CSF and chemotherapy. Absolutely in no case the plasma concentration of G-CSF is to be detected 48h before to 24h post chemotherapeutic drugs administration. In fact, this combination could result in an increased risk of mielotoxicity and a potential for an increase in sensitivity of rapidly dividing myeloid cells to cytotoxic-mutagenic chemotherapy potential. Lenograstim and filgrastim shows short half-life time, instead pegfilgrastim shows detectable concentrations for 16 days after a single administration. This is important to be considered, in particular in bi-weekly and tri-weekly adjuvant chemotherapy regimens. Anyway, the use of the lowest effective dose for the shortest adequate time of medications ensures the optimal balance among effectiveness, safety and costs of treatments, in a context that takes into account effectiveness and efficiency.Keywords Granulocyte-Colony Stimulating Factors; Lenograstim; Filgrastim; Pegfilgrastim; G-CSF; Timing; Appropriateness; Guidelines Appropriatezza d'uso dei fattori di crescita granulocitari nella profilassi e nel trattamento della neutropenia febbrile Introduzione Chemioterapia, neutropenia e G-CSFLa chemioterapia antiblastica, anche nell' era delle terapie target, resta il caposaldo del trattamento della maggioranza dei tumori solidi e delle neoplasie ematologiche. A fronte del beneficio clinico, alcuni effetti collaterali sono preminenti, in particolare la mielodepressione e, nell'ambito di questa, soprattutto la neutropenia. Il comparire di neutropenia durante il trattamento può portare una serie di ulteriori complicanze come la neutropenia febbrile e la riduzione della dose intensity, intesa come diminuzione della quantità di dose somministrata nell'unità di tempo. Da ciò deriva un possibile ridotto effetto dei farmaci sul controllo della malattia e quindi un peggiorato outcome [1]. Indubbiamente negli ultimi anni l'impiego in clinica...

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Short and long-term safety of lenograstim administration in healthy peripheral haematopoietic progenitor cell donors: a single centre experience

Cited by 35 publications

References 35 publications

Allogeneic hematopoietic stem cell donation—standardized assessment of donor outcome data: A consensus statement from the Worldwide Network for Blood and Marrow Transplantation (WBMT)

Allogeneic hematopoietic stem cell donation—standardized assessment of donor outcome data: A consensus statement from the Worldwide Network for Blood and Marrow Transplantation (WBMT)

Peripheric Stem Cell Collection Practices At Childhood

Appropriate administration of Granulocyte-Colony Stimulating Factors

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