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Nivestim (filgrastim): a new, convenient, daily G-CSF is effective for the prevention of febrile neutropenia
EJHP Author
European Journal of Oncology Pharmacy , 2010,
Abstract: Clinical research has shown that Nivestim can reduce the duration of chemotherapy-induced neutropenia (CIN) and prevent febrile neutropenia (FN) in patients with cancer.
Granulocyte colony-stimulating factor (filgrastim) in chemotherapy-induced febrile neutropenia
Advani S,Achreckar Suvarna,Thomas Dennis,Krishnankutty Binny
Indian Journal of Medical and Paediatric Oncology , 2010,
Abstract: Background: The use of granulocyte colony-stimulating factors to treat patients with chemotherapy-induced neutropenia is well accepted. To assess whether administration of filgrastim along with standard empiric antibiotic therapy is beneficial for patients with chemotherapy-induced febrile neutropenia (FN), we conducted an open, non-randomized clinical trial. Materials and Methods: This was a prospective, open, Phase IV clinical trial in patients receiving chemotherapy for histologically confirmed cancer, with an oral temperature of >38.2°C and absolute neutrophil count (ANC) of <500/mm 3 . Filgrastim was administered subcutaneously in a dose of 5 mcg/kg/day, 24 hours after administration of cytotoxic therapy, for up to two weeks or until the ANC reached 10,000 cells/mm 3 . The parameters of assessment included duration of neutropenia, fever, hospitalization and antibiotic usage. Results: All 24 evaluable patients recovered from neutropenia, fever and FN in a median duration of two days. This result is similar to that reported in earlier studies with filgrastim. Despite the acceleration in recovery from neutropenia and fever, it also reduced the duration of hospital stay and usage of intravenous (IV) antibiotic. Only two adverse events were reported, which were of mild nature. Conclusion: Filgrastim, when used in patients with chemotherapy-induced neutropenia, exhibited efficacy in accelerating the recovery from neutropenia and fever comparable to that reported with filgrastim in literature. The data from this study suggest that filgrastim is effective in the treatment of chemotherapy-induced neutropenia and is well tolerated by Indian patients.
Luciana Teofili,Immacolata Izzi,Eugenia Rosa Nuzzolo,Giancarlo Scoppettuolo
Mediterranean Journal of Hematology and Infectious Diseases , 2012, DOI: 10.4084/mjhid.2012.
Abstract: We retrospectively compared the incidence of neutropenia in two groups of HIV patients with lymphoma, who underwent chemotherapy supported by once-per-cycle administration of pegfilgrastim or by daily subcutaneous injection of filgrastim, respectively. Our findings indicate that pegfilgrastim and filgastrim produce similar results in preventing both neutropenia and febrile neutropenia.
Filgrastim as a Rescue Therapy for Persistent Neutropenia in a Case of Dengue Hemorrhagic Fever with Acute Respiratory Distress Syndrome and Myocarditis
Desh Deepak,Rakesh Garg,Mridula Pawar,Neerja Banerjee,Rakesh Solanki,Indubala Maurya
Case Reports in Anesthesiology , 2011, DOI: 10.1155/2011/896783
Abstract: Pathogenesis of dengue involves suppression of immune system leading to development of characteristic presentation of haematological picture of thrombocytopenia and leucopenia. Sometimes, this suppression in immune response is responsible for deterioration in clinical status of the patient in spite of all specific and supportive therapy. Certain drugs like steroids are used for rescue therapy in conditions like sepsis. We present a novel use of filgrastim as a rescue therapy in a patient with dengue hemorrhagic fever (DHF) with acute respiratory distress syndrome (ARDS), myocarditis, and febrile neutropenia and not responding to standard management.
Febrile neutropenia in haematological malignancies  [cached]
Sharma A,Lokeshwar N
Journal of Postgraduate Medicine , 2005,
Abstract: Fever is the principle sign of infection in neutropenic patient and frequently may be the only evidence of infection. The pattern of fever in neutropenia is non-specific and not pathognomonic of any type of infections or non-infectious process and can be suppressed by the antipyretic effects of drugs such as corticosteroids. Neutropenia, resulting from cytotoxic chemotherapy is the most common risk factor for severe infections in hematological malignancies. The duration of neutropenia also contributes significantly to the risk of serious infections. This risk is significantly greater a lower neutrophil counts, such that 100% patients with ANC < 100 cells/μl lasting 3 weeks or more develop documented infections. The prompt initiation of empirical antibiotics in febrile neutropenia has been the most important advance in the management of the immunocompromised host. The initial empirical antibiotic regimen started at presentation of the febrile episode frequently requires modifications especially in high-risk febrile neutropenia. Neutropenic patients who remain febrile despite 4-7 days of broad spectrum antibacterial therapy are at a high risk of invasive fungal infection. Empirical antifungal therapy with Amphotericin B in persistently febrile neutropenic patients and other high risk patients has shown to reduce the risk of invasive fungal infection by 50-80% and the risk of fungal infection related mortality by 23-45% in 1980′s. The IDSA has recommended that amphotericin B at 0.5-0.7 mg/kg/day be administered till marrow recovery. This approach is limited however by the adverse effects caused by drug infusion (fever, chills, myalgias, nausea, hypotension and bronchospasm). Lipid formulations which improve the therapeutic ratio of the traditional formulation are available. The safety and efficacy of these formulations is well established. These formulations have comparable efficacy and are less nephrotoxic than conventional amphotericin B.A lipid formulation of amphotericin B is appropriate as initial empirical therapy or as definitive therapy for proven mycosis in high risk patients receiving concomitant nephrotoxic drugs (cyclosporine), those with pre-existing renal impairment and those with protracted neutropenia during which dose limiting toxicity may occur.
Granulocyte colony-stimulating factors for febrile neutropenia prophylaxis following chemotherapy: systematic review and meta-analysis
Katy L Cooper, Jason Madan, Sophie Whyte, Matt D Stevenson, Ron L Akehurst
BMC Cancer , 2011, DOI: 10.1186/1471-2407-11-404
Abstract: A systematic review and meta-analysis assessed the effectiveness of G-CSFs (pegfilgrastim, filgrastim or lenograstim) in reducing FN incidence in adults undergoing chemotherapy for solid tumours or lymphoma. G-CSFs were compared with no primary G-CSF prophylaxis and with one another. Nine databases were searched in December 2009. Meta-analysis used a random effects model due to heterogeneity.Twenty studies compared primary G-CSF prophylaxis with no primary G-CSF prophylaxis: five studies of pegfilgrastim; ten of filgrastim; and five of lenograstim. All three G-CSFs significantly reduced FN incidence, with relative risks of 0.30 (95% CI: 0.14 to 0.65) for pegfilgrastim, 0.57 (95% CI: 0.48 to 0.69) for filgrastim, and 0.62 (95% CI: 0.44 to 0.88) for lenograstim. Overall, the relative risk of FN for any primary G-CSF prophylaxis versus no primary G-CSF prophylaxis was 0.51 (95% CI: 0.41 to 0.62). In terms of comparisons between different G-CSFs, five studies compared pegfilgrastim with filgrastim. FN incidence was significantly lower for pegfilgrastim than filgrastim, with a relative risk of 0.66 (95% CI: 0.44 to 0.98).Primary prophylaxis with G-CSFs significantly reduces FN incidence in adults undergoing chemotherapy for solid tumours or lymphoma. Pegfilgrastim reduces FN incidence to a significantly greater extent than filgrastim.Neutropenia is the major dose-limiting toxicity of many chemotherapy regimens. Grade 3 and grade 4 neutropenia are defined as a neutrophil count < 1.0 × 109/L and < 0.5 × 109/L respectively. Febrile neutropenia (FN) is defined as neutropenia with fever, usually indicating infection, and is associated with substantial morbidity, mortality, and costs [1]. The direct risk of mortality associated with FN has been estimated as 9.5% (95% confidence interval [CI]: 9.2%, 9.8%) in a study of 41,779 cancer patients hospitalised with FN [1]. Management of FN often requires lengthy hospitalisation, [1] with associated costs and detrimental effects on qu
NEUTROPENIA FEBRIL EN PEDIATRIA Febrile Neutropenia in Pedriatrics  [cached]
Pio Lopez,Eduardo Lopez
Infectio , 2008,
Abstract: La neutropenia febril es una condición frecuente en los pacientes pediátricos con cáncer. En el momento en que se hace este diagnóstico, el médico debe conducir una entrevista y un examen físico rigurosos, obtener cultivos e iniciar antibióticos para combatir un amplio espectro de microorganismos. La decisión de suspender los antibióticos se debe basar en el conteo de neutrófilos, la persistencia de la fiebre y la presencia o ausencia de factores de riesgo. Presentamos una revisión reciente de la literatura en esta condición tan frecuentemente asociada con morbimortalidad en ni os. Febrile neutropenia is a frequent condition among pediatric patients with cancer. When this diagnosis is made, the physician must conduct a thorough interview and physical exam, cultures need to be obtained and antibiotics started to cover a wide spectrum of microorganisms. The decision of stopping antibiotics must be made based on the neutrophile count, the persistence of fever and the presence or absence of risk factors. We present a current review of the literature on this condition so highly associated with morbimortality in children.
The comparison of the preventive effects of filgrastim and lenograstim in pediatric cancer patients treated with chemotherapy and radiotherapy
G?rkem AKSU,Funda ?ORAP?IO?LU,Merdan FAYDA,Evi? Z. BA?AR
Turkish Journal of Oncology , 2007,
Abstract: OBJECTIVES: To compare the preventive effects of filgrastim and lenograstim in pediatric cancer patients treated with chemotherapy and radiotherapy. METHODS: Eighty-two patients treated with myelosuppressive chemotherapy and/or radiotherapy in Pediatric Oncology and Radiation Oncology Departments of Kocaeli University, Faculty of Medicine between September 2005 and March 2007 were randomized to filgrastim and lenograstim arms. Radiotherapy doses and fields 3 weeks prior to the therapy, age, gender, histopathological type of the tumor, stage and chemotherapy protocols were recorded. Patients with bone marrow infiltration due to the tumoral invasion and patients receiving steroid including chemotherapy regimens were excluded from the study. Equivalent doses of two hematopoetic growth factors (filgrastim 5 μg/kg/day, S.C; lenograstim 150 μg/m2/day, S.C) were applied beginning 24 hours following the completion of the chemotherapy till leukocyte count reached 10.000/mm3. RESULTS: Delay in the new chemotherapy cure following chemotherapy protocol was median 5 days in lenograstim arm (16 patients, 37%) while it was 3 days in filgrastim arm (10 patients; %25) however the difference was not statistically significant (p=0.188). In lenogastrim arm, febrile neutropenia occurred in 6 patients and infections without neutropenia were seen in 4 patients (pneumonia in 2 patients, otitis media in 1 patient and pharengitis in 1 patient). In filgrastim arm, febrile neutropenia occurred in 3 patients and gingivitis and gastroenteritis in 2 patients and the difference between two groups was also not significant (p=0.258). However, bone pain was present in 2 patients in lenograstim arm while it was seen in 10 patients in filgrastim arm with a significant difference (p=0.008). CONCLUSION: Although preventive effects of filgrastim and lenograstim on febrile neutropenia and non-neutropenic infections in patients receiving radiotherapy and chemotherapy are not significantly different, delay in the new chemotherapy cure following chemotherapy protocol is shorter in filgrastim arm. However, bone pain is also significantly higher in filgrastim arm.
XM02 is superior to placebo and equivalent to Neupogen? in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle 1 in breast cancer patients receiving docetaxel/doxorubicin chemotherapy
A del Giglio, A Eniu, D Ganea-Motan, E Topuzov, H Lubenau
BMC Cancer , 2008, DOI: 10.1186/1471-2407-8-332
Abstract: A total of 348 patients with BC receiving docetaxel/doxorubicin chemotherapy were randomised to treatment with daily injections (subcutaneous 5 μg/kg/day) for at least 5 days and a maximum of 14 days in each cycle of XM02 (n = 140), Neupogen? (n = 136) or placebo (n = 72). The primary endpoint was the duration of severe neutropenia (DSN) in cycle 1.The mean DSN in cycle 1 was 1.1, 1.1, and 3.9 days in the XM02, Neupogen?, and placebo group, respectively. Superiority of XM02 over placebo and equivalence of XM02 with Neupogen? could be demonstrated. Toxicities were similar between XM02 and Neupogen?.XM02 was superior to placebo and equivalent to Neupogen? in reducing DSN after myelotoxic chemotherapy.Current Controlled Trials ISRCTN02270769Myelotoxic chemotherapy frequently leads to neutropenia. Recombinant granulocyte colony-stimulating factors (G-CSFs) are effective pharmaceutical substances and are successfully applied in the prevention of chemotherapy-induced neutropenia and the associated risk of infection. [1-3]Natural human G-CSF is a glycoprotein composed of a single polypeptide chain of 174 or 177 amino acids.[4,5] The first bacterially synthesised non-glycosylated recombinant methionyl form of human G-CSF (r-metHuG -CSF) was approved by the Food and Drug Administration (FDA) in 1991 under the generic name Filgrastim. Alternatively, a second glycosylated recombinant human G-CSF is available on the market under the generic name Lenograstim which is produced by Chinese hamster ovary (CHO) cells.More recently, a biosimilar non-glycosylated r-metHuG-CSF expressed in Escherichia coli for intravenous (i.v.) and subcutaneous (s.c.) administration was clinically developed by BioGeneriX AG for the treatment of chemotherapy-induced neutropenia. The manufacturing process was developed by Sicor Biotech. XM02 will be named with the international non-proprietary name filgrastim. Filgrastim marketed under the trade name Neupogen? was used as reference product in this study.
Goran Marjanovi?,Vesna Marjanovi?,Mladen Milenovi?,Lana Ma?ukanovi?-Golubovi?
Acta Facultatis Medicae Naissensis , 2003,
Abstract: In the selection of the initial antibiotic regimen, one should consider the type, frequency of occurrence, and antibiotic susceptibility of bacterial isolates recovered from other patients at the same hospital. We emphasize that no specific scheme, no specific drug or combination of drugs, and no specific period of treatment can be unequivocally applied to all febrile neutropenic patients. The outpatient approach with oral antibiotics for low risk group of patients should be apllied whenever possible. Hospital tretment is mandatory for all accute leukemia patients with various initial empirical antibiotic therapy aproaches such as monotherapy, therapy consisting of 2 parenteral drugs with or without addition of vankomycine. Our expirience with accute leukemia patients favor the last combination.In this study recommendations conserning antiviral prophilaxis, duration of antibiotic therapy as well as situations when changes of regimen are necessery in casess of prolonged neutropenia with complications were rewieved.It is important to note that the guidelines are general and must be applied wisely with respect to variations in individual patients and types of infections, settings in which patients are being treated, antimicrobial susceptibility patterns, underlying causes of neutropenia, and expected time of recovery.
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