The Safety Profile of Filgrastim and Pegfilgrastim

Neumann, Theresa; Foote, MaryAnn

doi:10.1007/978-3-0348-0218-5_21

Cited by 8 publications

(4 citation statements)

References 63 publications

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“…Further investigation of this hypothesis in prospective, randomized studies is warranted. Finally, bone pain was most commonly observed in patients treated with BIO/G-CSF, consistent with previous reports [ 35 ].…”

Section: Discussionsupporting

confidence: 91%

Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high-dose melphalan and autologous stem cell transplantation

et al. 2023

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Multiple myeloma (MM) is the main indication for autologous stem cell transplantation (ASCT). Novel supportive therapies (e.g., granulocyte colony-stimulating factor) have significantly improved post-ASCT-related mortality; however, data on biosimilar pegfilgrastim-bmez (BIO/PEG) in this setting is lacking. This prospective cohort study compared Italian patients with MM who received BIO/PEG post-ASCT with data collected retrospectively from historical control groups from the same center who received either filgrastim-sndz (BIO/G-CSF) or pegfilgrastim (PEG; originator). The primary endpoint was time to neutrophil engraftment (three consecutive days with an absolute neutrophil count ≥ 0.5 × 109/L). Secondary endpoints included incidence and duration of febrile neutropenia (FN). Of the 231 patients included, 73 were treated with PEG, 102 with BIO/G-CSF, and 56 with BIO/PEG. Median age was 60 years and 57.1% were male. Neutrophil engraftment was reached after a median of 10 days in the BIO/PEG and PEG groups and 11 days in the BIO/G-CSF group. Among patients who achieved neutrophil engraftment earlier than this (i.e., day 9), 58% (29/50) were on PEG; of those who achieved it later (i.e., day 11), 80.8% (59/73) were on BIO/G-CSF. FN incidence was higher with BIO/G-CSF (61.4%) versus PEG (52.1%) or BIO/PEG (37.5%) (p = 0.02 among groups). Patients on BIO/PEG had less frequent grade 2–3 diarrhea (5.5%) compared with BIO/G-CSF (22.5%) or PEG (21.9%); grade 2–3 mucositis was most frequent in the BIO/G-CSF group. In conclusion, pegfilgrastim and its biosimilar displayed an advantageous efficacy and safety profile compared with biosimilar filgrastim in patients with MM post-ASCT.

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Section: Discussionsupporting

confidence: 91%

Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high-dose melphalan and autologous stem cell transplantation

et al. 2023

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“…Some studies have reported higher BPT incidence and thus higher mortality in G-CSF co-administration, while others did not show any association (9). Several randomized and nonrandomized studies with different diagnoses include advanced testicular cancer, germ-cell tumors, Hodgkin and non-Hodgkin's lymphoma (NHL), and metastatic teratoma, reported no increase in BPT in the co-administration of filgrastim (7,60).…”

Section: Subgroup Analysis and Meta-regressionmentioning

confidence: 99%

The effect of concomitant use of Colony-Stimulating factors on bleomycin pulmonary toxicity – A systematic review and meta-analysis

Sani

Sahranavard

Yazdanabad

et al. 2022

International Immunopharmacology

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“…6,7 The synthetic G-CSF or filgrastim or Neupogen which was developed as a recombinant protein and produced in Escherichia coli was approved for clinical used in 1991. 8,9 It has been used as the first line therapy for chemotherapyinduced neutropenia and proven to be well tolerated by the patients. 10 Following the patent expiration of Neupogen as the recombinant human G-CSF (rhG-CSF) originator, development of rhG-CSF biosimilar has become interesting for researchers and pharmaceutical industries.…”

Section: Introductionmentioning

confidence: 99%

Bioassay of Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) for Neutropenia Treatment in Male Sprague Dawley Rats

Pratiwi

Agustiyanti

Dewi

et al. 2020

Mol Cell Biomed Sci

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Background: Recombinant human granulocyte colony stimulating factor (rhG-CSF) is a first line therapy for neutropenia. However, it is less affordable for most patients in developing and poor countries. Therefore, biosimilar products are developed to suppress the cost of treatment, namely with rhG-CSF. This study aimed to explore the establishment of an affordable rhG-CSF that has similar potential to induce neutrophils recovery as the positive control.Materials and Methods: The rhG-CSF was expressed as inclusion body in Escherichia coli NiCo21(DE3). The inclusion body was then solubilized, refolded, purified and characterized prior to be used in the bioactivity assay. Cyclophosphamide-induced male Sprague Dawley rats were used as animal model and administered with rhG-CSF. Blood sample was collected at several points of time, before and after rhG-CSF treatments. Complete blood count and peripheral blood smear were conducted to investigate the activity of the rhG-CSF on each blood cells type, particularly neutrophil.Results: Specific activity on neutrophil proliferation was shown after treatments with our rhG-CSF and positive control. Positive control dose 40 mg/kg BW was statistically similar with that of the rhG-CSF dose 80 and 120 mg/kg BW. However, in neutropenic condition, recovery of neutrophil counts could not be achieved within 4 days of treatments. Thus, a longer treatment is needed to observe the activity of the rhG-CSF as an antineutropenia agent.Conclusion: The rhG-CSF has been proven having specific activity on neutrophil proliferation. However, improvement in the rhG-CSF preparation is still needed and longer administration of the rhG-CSF has to be applied in the future study.Keywords: rhG-CSF, biosimilar, neutropenia, Sprague Dawley rats

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The Safety Profile of Filgrastim and Pegfilgrastim

Cited by 8 publications

References 63 publications

Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high-dose melphalan and autologous stem cell transplantation

Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high-dose melphalan and autologous stem cell transplantation

The effect of concomitant use of Colony-Stimulating factors on bleomycin pulmonary toxicity – A systematic review and meta-analysis

Bioassay of Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) for Neutropenia Treatment in Male Sprague Dawley Rats

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