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Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction-The REC-DUT-002 Trial. Patients with acute myocardial infarction are at high risk for developing heart failure due to scar development. Although regenerative approaches are evolving, consistent clinical benefits have not yet been reported. Treatment with dutogliptin, a second-generation DPP-4 inhibitor, in co -administration with filgrastim (G-CSF) has been shown to enhance endogenous repair mechanisms in experimental models. The REC-DUT-002 trial was a phase 2, multicenter, double-blind placebo-controlled trial which explored the safety, tolerability, and efficacy of dutogliptin and filgrastim in patients with ST-elevation Myocardial Infarction (STEMI). Patients ( = 47, 56.1 ± 10.7 years, 29% female) with STEMI
Utilization of Filgrastim and Infliximab Biosimilar Products in Medicare Part D, 2015-2019. This cross-sectional study examines utilization trends for filgrastim and infliximab products and their biosimilars to understand whether biosimilars are associated with reduced spending in Medicare Part D.
A prospective study of filgrastim pharmacokinetics in morbidly obese patients compared with non-obese controls. Filgrastim is a human granulocyte colony-stimulating factor (G-CSF). There are limited data on dosing filgrastim in obesity. The objective of this study was to compare filgrastim pharmacokinetic parameters for morbidly obese and non-obese patients after a single subcutaneous dose of filgrastim dosed per actual body weight. This prospective, matched-pair study (NCT01719432) included patients ≥18 years of age, receiving filgrastim at 5 μg/kg with a weight >190% of their ideal body weight (IBW) for "morbidly obese" patients or within 80%-124% of IBW for matched-control patients. The control group was prospectively matched for age (within 10 years), degree of neutropenia, and gender
The Effect of Neutropenia and Filgrastim (G-CSF) on Cancer Patients With Coronavirus Disease 2019 (COVID-19) Infection. Neutropenia is commonly encountered in cancer patients. Recombinant human granulocyte colony-stimulating factor (G-CSF, filgrastim), a cytokine that initiates proliferation and differentiation of mature granulocytes, is widely given to oncology patients to counteract
Zarxio (filgrastim-sndz) - statistical review CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125553Orig1s000 STATISTICAL REVIEW(S) U.S. Department of Health and Human ServicesFood and Drug Administration Center for Drug Evaluation and ResearchOffice of Translational SciencesOffice of BiostatisticsSTATISTICAL REVIEW AND EVALUATIONCLINICAL STUDIES- BIOSIMILAR PRODUCTNDA/BLA Health Service Act (PHS Act) to supportEP2006 as a biosimilarproductto US-licensed Neupogen(filgrastim). Sandoz is seeking licensure of EP2006 for the same indications as currently approved for Neupogen:The indications are as follows:1) to decrease the incidence of infections, as manifested by febrile neutropenia,in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs
Zarxio (filgrastim-sndz) - medical review CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125553Orig1s000 MEDICAL REVIEW(S) Page 1 Secondary (Team Leader) Review Date February 3, 2015 From Albert Deisseroth, MD, PhD Subject Secondary Review BLA Number 125553 Applicant Sandoz Date of Submission May 8, 2014 PDUFA Goal Date March 8, 2015 Proprietary Name Zarxio Dosage ..............................................................................................10 12. REGULATORY RECOMMENDATIONS..........................................................10 Reference ID: 3699309 Page 3 1. EXECUTIVE SUMMARY: On May 8, 2014, Sandoz submitted BLA 125553 requesting licensure of EP2006 as a biosimilar to US-licensed Neupogen under Section 351(k) of the Public Health Service Act. The proposed proprietary name is Zarxio. Filgrastim
Accofil (filgrastim) 24 July 2014 EMA/CHMP/603430/2014 Committee for Medicinal Products for Human Use (CHMP) CHMP assessment report Accofil International non-proprietary name: filgrastim Procedure No.: EMEA/H/C/003956 Note Assessment report as adopted by the CHMP with all information of a commercial confidential nature deleted. 30 Churchill Place ● Canary Wharf ● London E14 5EU of primary prophylaxis in reducing the frequency of hospitalisation for antibiotic therapy, documented infection, and rates of neutropenic fever in adults. The impact on survival is less clear (Kuderer et al., J. Clin Oncol 2007; 25:3158). Recombinant hG-CSF (filgrastim) has been introduced in clinical use since 1991 under the trade name Neupogen. Recombinant hG-CSF is produced in E. coli. Its amino acid
Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial. The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non
Comparison of CD34(+) cell mobilization, blood graft cellular composition, and post-transplant outcome in myeloma patients mobilized with filgrastim or pegfilgrastim added to low-dose cyclophosphamide: A prospective multicenter study. Scarce data exist on the impact of granulocyte-colony stimulating factor (G-CSF) type on the mobilizing capacity of CD34 cells, graft cellular composition , and outcome in myeloma (MM) patients. In this prospective multicenter study, 70 patients with MM received filgrastim (FIL) and 20 patients received pegfilgrastim (PEG) as a G-CSF after low-dose cyclophosphamide. Flow cytometry was used to analyze the mobilization of CD34 cells and cellular composition of blood grafts, hematologic recovery, and survival after auto-SCT according to the G-CSF choice. The CD34
Biosimilarity Assessment of 2 Filgrastim Therapeutics in Healthy Volunteers. This study aimed to compare the pharmacokinetic, pharmacodynamic, and safety profiles of a proposed biosimilar and innovator filgrastim therapeutics in healthy volunteers. In a crossover design, 23 subjects received a single subcutaneous injection of 300-µg filgrastim, followed by a 7-day washout period. Assessed pharmacokinetic parameters were the maximum observed filgrastim serum concentration (C ), time to reach C (t ), the area under the concentration-time curve (AUC), and elimination half-life. Pharmacodynamics were assessed by the maximum observed absolute neutrophil count effect (E ), t (time to reach E ), and the area under the effect of the absolute neutrophil count -time curve. The test/reference ratio (90
Filgrastim An official website of the United States government Here's how you know Log inAccess keysNCBI HomepageMyNCBI HomepageMain ContentMain NavigationBookshelfSearch databaseBooksAll DatabasesAssemblyBiocollectionsBioProjectBioSampleBooksClinVarConserved DomainsdbGaPdbVarGeneGenomeGEO DataSetsGEO ProfilesGTRHomoloGeneIdentical Protein GroupsMedGenMeSHNLM and EffectsSummary of Use during LactationFilgrastim in the pharmaceutical name for granulocyte colony-stimulating factor (G-CSF). Pegfilgrastim is the long-acting form of filgrastim. Eflapegrastim is a closely related G-CSF analogue. The excretion of exogenous G-CSF into breastmilk or its effects on breastfed infants have not been well studied. Limited data indicate that filgrastim and a similar G-CSF product
Provider differences in biosimilar uptake in the filgrastim market. To identify differences in biosimilar uptake across providers and to examine the association between provider biosimilar uptake and observable practice-level characteristics. A retrospective analysis of 100% of a commercial medical claims database from June 2015 to June 2018. We focused on providers of biologic (Neupogen ) and biosimilar (Zarxio) filgrastim. We compared trends in biosimilar uptake across 2 dimensions: provider's place of service and provider's prescribing exclusivity. We then used multivariate regression analysis to estimate the association between any biosimilar uptake and practice-level characteristics, controlling for geography and time fixed effects. Relative to hospital-based providers, office-based
Quantification and Qualification of Stem Cells from Blood after Mobilization with Filgrastim, and Concentration Using a PRP System. To determine the cellular composition of a product created with peripheral blood harvested after systemic mobilization with filgrastim and processed with one point-of-care blood concentrating system, i.e., a platelet-rich plasma (PRP) system. The second purpose was to compare mobilized platelet-rich plasma (M-PRP) with a concentrated bone marrow aspirate (cBMA) and a PRP created from the same subjects with the same PRP system. Ten healthy volunteer subjects were recruited for collection and analysis of 3 tissue sources: non-treated peripheral blood, bone marrow aspirate, and filgrastim-mobilized peripheral blood, involving 4 doses of weight-based filgrastim. One
G-CSF (filgrastim) treatment for amyotrophic lateral sclerosis: protocol for a phase II randomised, double-blind, placebo-controlled, parallel group, multicentre clinical study (STEMALS-II trial). Amyotrophic lateral sclerosis (ALS) is a fatal progressive neurological disorder characterised by a selective degeneration of motor neurons (MNs). Stem cell transplantation is considered as a promising , randomised double-blind, placebo-controlled, parallel group clinical trial on G-CSF (filgrastim) and mannitol in ALS patients. Specifically, we investigate safety, tolerability and efficacy of four repeated courses of intravenous G-CSF and mannitol administered in 76 ALS patients in comparison with placebo (indistinguishable glucose solution 5%). We determine increase of G-CSF levels in serum
Avoiding Peg-Filgrastim Prophylaxis During the Paclitaxel Portion of the Dose-Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen: A Prospective Study. The use of growth factors adds considerable expense and some toxicity to adjuvant breast cancer chemotherapy. We tested the feasibility and safety of omitting routine peg-filgrastim use during the paclitaxel portion of the dose-dense doxorubicin-cyclophosphamide-paclitaxel regimen. This was a prospective, single-arm study in which patients 18 to 65 years of age who completed 4 cycles of dose-dense doxorubicin-cyclophosphamide for stage I-III breast cancer received paclitaxel 175 mg/m every 2 weeks. Peg-filgrastim was administered after paclitaxel only if patients had had febrile neutropenia in a prior cycle or at investigator discretion
A multicentre, randomised trial comparing schedules of G-CSF (filgrastim) administration for primary prophylaxis of chemotherapy-induced febrile neutropenia in early stage breast cancer. The optimal duration of filgrastim as primary febrile neutropenia (FN) prophylaxis in early breast cancer patients is unknown, with 5, 7 or 10 days being commonly prescribed. This trial evaluates whether 5 days of filgrastim was non-inferior to 7/10 days. In this randomised, open-label trial, early breast cancer patients who were to receive filgrastim as primary FN prophylaxis were randomly allocated to 5 versus 7 versus 10 days of filgrastim for all chemotherapy cycles. A protocol amendment in November 2017 allowed subsequent patients (N = 324) to be randomised to either 5 or 7/10 days. The primary outcome
A pilot study on intermittent every other days of 5-dose Filgrastim compared with single Pegfilgrastim in breast Cancer patients receiving adjuvant Docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy. Aim To compare the efficacy and safety of intermittent every other days 5-dose filgrastim with single pegfilgrastim in patients with breast cancer receiving adjuvant docetaxel , doxorubicin, and cyclophosphamide (TAC) chemotherapy. Methods In this pilot study, Korean patients who had undergone complete resection for breast cancer and scheduled for adjuvant TAC chemotherapy were enrolled. Patients were randomized to receive either intermittent 5 doses of filgrastim (5 mcg/kg/day) or once-a-cycle pegfilgrastim (6 mg) as primary prophylaxis during the first three cycles of the TAC