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 > 10000/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.
Clinical Trials Related to Neupogen (Filgrastim)
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of YPEG-Filgrastim in Chemotherapy Patients [Recruiting]
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a
single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish
dose-response relationships between YPEG-Filgrastim and Filgrastim(rhG-CSF, TOPNEUTER).
Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors [Recruiting]
The purpose of the study is to:
- Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood
stem cells from National Marrow Donor Program donors (NMDP) donors
- Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis
- Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor
hematopoietic stem cell transplant recipients
- Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in
normal donors
Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim [Recruiting]
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.
Randomized Phase III Trial of Leukine® Vs Neupogen® in Patients Receiving Cisplatin & Gemcitabine for Urothelial Cancer [Terminated]
The main objective of this study is to compare the effectiveness of Leukine & Neupogen to
decrease the incidence of grade 3 & 4 neutropenia in the treatment of patients receiving
cisplatin & gemcitabine for urothelial (bladder) cancer.
All patients will receive chemotherapy with cisplatin plus gemcitabine in six 21-day cycles.
Patients will also receive either Leukine (Arm A) or Neupogen (Arm B).
Patient Population: 100 patients will be enrolled (n=100) in this study. Patients cannot
have undergone previous chemotherapy. Approximately 50 patients will be enrolled into each
treatment arm.
Test Product, Dose, Mode of Administration: All patients will receive chemotherapy treatment
with cisplatin (70 mg/kg) on Day 1 and gemcitabine (1000 mg/m2) on Days 1, 8, & 15 of each
21-day cycle. Patients will be randomized to receive either Leukine (250 µg/m2) or Neupogen
(5 µg/kg) injected under the skin on Days 2-6, 9-13, & 16-20 of each cycle.
Duration of Treatment: Patients will receive a maximum of six 21-day cycles of treatment.
The overall trial, including follow-up, is expected to be 3 years in duration.
Effect of Body Mass on Filgrastim Pharmacokinetics [Recruiting]
Studies have shown that different percentages of body fat can alter the way drugs are
distributed in the body. This study will use blood samples taken at different time points
for patients taking Neupogen to determine if higher body weights affect drug exposure. The
information gathered from this study will help understand if patients with higher body
weights need a different dosing plan.
Patients in this study will have blood draws once before they take Neupogen and 6 times
after they take the Neuopen (for a total of 24 hours). These patients will be in the
hospital already and will not need to make additional trips back to have blood drawn. A
total of about 5-6 tablespoons of blood will be drawn for this study. 15 obese patients and
15 matched, non-obese patients will be enrolled into this study.
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 >>
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