Neupogen (Filgrastim) - Summary

NEUPOGEN SUMMARY

Filgrastim is a human granulocyte colony-stimulating factor (G-CSF)‚ produced by recombinant DNA technology. NEUPOGEN^® is the Amgen Inc. trademark for Filgrastim‚ which has been selected as the name for recombinant methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF). NEUPOGEN^® is a 175 amino acid protein manufactured by recombinant DNA technology. ¹ NEUPOGEN^® is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene.

Cancer Patients Receiving Myelosuppressive Chemotherapy

NEUPOGEN^® is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (see CLINICAL EXPERIENCE). A complete blood count (CBC) and platelet count should be obtained prior to chemotherapy‚ and twice per week (see LABORATORY MONITORING) during NEUPOGEN^® therapy to avoid leukocytosis and to monitor the neutrophil count. In phase 3 clinical studies‚ NEUPOGEN^® therapy was discontinued when the ANC was ≥ 10‚000/mm³ after the expected chemotherapy-induced nadir.

Patients With Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy

NEUPOGEN^® is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with AML.

Cancer Patients Receiving Bone Marrow Transplant

NEUPOGEN^® is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ eg‚ febrile neutropenia‚ in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation (see CLINICAL EXPERIENCE). It is recommended that CBCs and platelet counts be obtained at a minimum of 3 times per week (see LABORATORY MONITORING) following marrow infusion to monitor the recovery of marrow reconstitution.

Patients Undergoing Peripheral Blood Progenitor Cell Collection and Therapy

NEUPOGEN^® is indicated for the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. Mobilization allows for the collection of increased numbers of progenitor cells capable of engraftment compared with collection by leukapheresis without mobilization or bone marrow harvest. After myeloablative chemotherapy‚ the transplantation of an increased number of progenitor cells can lead to more rapid engraftment‚ which may result in a decreased need for supportive care (see CLINICAL EXPERIENCE).

Patients With Severe Chronic Neutropenia

NEUPOGEN^® is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (eg‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia (see CLINICAL EXPERIENCE). It is essential that serial CBCs with differential and platelet counts‚ and an evaluation of bone marrow morphology and karyotype be performed prior to initiation of NEUPOGEN^® therapy (see WARNINGS). The use of NEUPOGEN^® prior to confirmation of SCN may impair diagnostic efforts and may thus impair or delay evaluation and treatment of an underlying condition‚ other than SCN‚ causing the neutropenia.

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NEWS HIGHLIGHTS

Published Studies Related to Neupogen (Filgrastim)

Pegfilgrastim vs. filgrastim for supportive care after autologous stem cell transplantation: can we decide? [2011.10.31]
Ziakas PD, Kourbeti IS.Both drugs are at least equally effective, though methodology and disease stratification in published trials warrant further improvement.

Lenograstim reduces the incidence of febrile episodes, when compared with filgrastim, in multiple myeloma patients undergoing stem cell mobilization. [2011.07]
The aim of this study was to show a lower incidence of febrile episodes in multiple myeloma patients receiving lenograstim vs... The study demonstrated a lower incidence of febrile episodes with lenograstim compared to filgrastim.

Priming with r-metHuSCF and filgrastim or chemotherapy and filgrastim in patients with malignant lymphomas: a randomized phase II pilot study of mobilization and engraftment. [2011.01]
SCF has been shown to synergize with G-CSF to mobilize CD34(+) PBPCs. In this study we report results from this combination after a phase II trial of 32 patients with malignant lymphoma randomized to receive recombinant methionyl human SCF (ancestim, r-metHuSCF) in combination with recombinant methionyl human G-CSF (filgrastim, r-metHuG-CSF) (experimental arm A) or routine chemotherapy plus filgrastim (conventional arm B)...

Comparison of the pharmacodynamic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial. [2010.10]
Further to the patent expiry of Neupogen (Amgen filgrastim), Hospira has developed a biosimilar filgrastim (Nivestim) that may offer a clinically effective alternative for multiple hematologic and oncologic indications... Hospira filgrastim is bioequivalent with Amgen filgrastim with regard to its pharmacodynamic characteristics.

Pharmacokinetic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial. [2010.09]
Recombinant human granulocyte colony-stimulating factor (filgrastim) has multiple hematologic and oncologic indications as Neupogen (Amgen filgrastim)... Hospira filgrastim is bioequivalent with Amgen filgrastim in terms of its pharmacokinetic properties and may provide a clinically effective alternative.

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Clinical Trials Related to Neupogen (Filgrastim)

Heparin Binding Protein in Patients With Acute Respiratory Failure Treated With GCSF (Filgrastim) [Completed]

This is a study of plasma HBP - levels of a previously published trial of G-CSF in critically

ill patients (Pettila et al. Critical Care Medicine 2000). The original study was a prospective, randomised, double-blind, placebo-controlled trial of filgrastim in patients with acute respiratory failure requiring intubation. In this substudy, the investigators

evaluated the effect of filgrastim on HBP - concentrations in critically ill patients.

Safety and Efficacy of TXA127 and Neupogen to Increase Peripheral Blood Stem Cells (PBSCs) [Completed]
This is a Phase I Study to be conducted in 18 healthy volunteers. Each will receive daily injections for 5 days of TXA127 alone, or Neupogen alone, or TXA127 plus Neupogen together. The aim of the study is to determine the safety of the TXA127 alone and in combination with Neupogen, and to determine whether the use of TXA127 alone or in combination with Neupogen enhances peripheral blood stem cell (CD34+)mobilization.

Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma [Recruiting]
This study will compare the results of stem cell mobilization using drugs called filgrastim (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02 filgrastim (Granix) and plerixafor.

Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim [Completed]
The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

Prophylactic Use of Filgrastim SD/01 in Patients With Hodgkin's Disease Receiving ABVD Chemotherapy [Completed]
Prophylactic use of Filgrastim SD/01 for patients with Hodgkin's lymphoma receiving ABVD chemotherapy.

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Reports of Suspected Neupogen (Filgrastim) Side Effects

Febrile Neutropenia (89),  Neutropenia (70),  Pneumonia (65),  Pyrexia (53),  White Blood Cell Count Decreased (49),  Deep Vein Thrombosis (44),  Drug Ineffective (41),  Diarrhoea (38),  Bone Pain (36),  Infection (35), more >>