Filgrastim 30million units/1ml solution for injection vials

BACKGROUND: While rare, radiological and nuclear (RN) emergencies pose complex challenges that require tailored preparedness strategies. A key aspect is the strategic stockpiling of medical countermeasures (MCMs), yet existing literature offers limited and fragmented recommendations regarding their appropriate composition. METHODS: This systematic review, conducted following PRISMA guidelines, aims to consolidate and critically appraise available evidence on stockpiling for RN emergencies. Seven databases and selected grey literature sources were screened from 2011 onward. Studies were included if they provided direct or indirect recommendations on stockpiling items. Data extraction was conducted in two steps by independent pairs of reviewers, and identified items were categorized as therapeutics, medical devices, personal protective equipment (PPE), or RN-specific equipment. Items were further analyzed for regulatory status, administration route, shelf-life, and storage requirements. RESULTS: Thirty-two articles met the inclusion criteria. Therapeutics dominated the findings, with 50 distinct agents identified, most frequently potassium iodide, Prussian Blue, Ca-/Zn-DTPA, and hematopoietic growth factors such as filgrastim. In contrast, medical devices were not supported by a sufficient level of stockpiling recommendation, while PPE (6 of 32 articles) and RN equipment (14 of 32 articles) were cited less often. Pediatric considerations were rarely addressed, with 2 studies explicitly focused on this population. Gaps in operational guidance, regulatory harmonization, and standardized planning emerged across the literature. CONCLUSIONS: This review highlights that stockpiling recommendations for RN emergencies remain limited, with greater guidance concentrated on a few therapeutics and little direction for other items. The findings provide an informative evidence base to support more consistent policy and preparedness planning.

Abstract licence: CC BY-NC-ND

BackgroundGranulocyte colony-stimulating factors (G-CSFs), including filgrastim and pegfilgrastim, are associated with bone pain, potentially impacting treatment adherence. This study hypothesized that a 5-day regimen of filgrastim would result in less bone pain than single-dose pegfilgrastim in patients receiving chemotherapy for early breast cancer.MethodsIn this multicenter, open-label, randomized controlled trial, patients requiring prophylactic G-CSF during chemotherapy were randomly assigned 1:1 to receive either 5-day filgrastim or pegfilgrastim. The primary outcome was patient-reported bone pain, assessed as area under the curve of daily pain scores (0 = no pain to 10 = worst pain) over the first 5 days following G-CSF in cycle 1. Secondary outcomes included bone pain in cycles 2-4, febrile neutropenia, hospitalizations, chemotherapy delays, dose reductions, early discontinuations, chemotherapy-related deaths, health-related quality of life, and health-care resource utilization.ResultsFrom June 2021 to March 2023, a total of 233 patients were randomly assigned, with 219 analyzed (110 filgrastim and 109 pegfilgrastim) after excluding those who withdrew before receiving treatment. Adjusting for stratification factors and prespecified baseline covariates using repeated measures linear regression, the mean area under the curve (0-40) for cycle 1 bone pain was 10.2 (11.2) for 5-day filgrastim and 10.2 (9.81) for pegfilgrastim, with an adjusted mean difference of 0.70 (95% confidence interval = 1.62 to 3.02; P = .556). Although no clinically significant differences were observed in most secondary outcomes, the 5-day filgrastim group exhibited a numerically higher incidence of febrile neutropenia (6.4% vs 0.9%, P = .065) and hospitalization (10.0% vs 3.7%, P = .106).ConclusionThere was no significant difference in bone pain between 5-day filgrastim and pegfilgrastim.

Abstract licence: CC BY

Background and objectivesNeutropenia is the most severe hematologic toxicity of myelosuppressive chemotherapy. The objective of this study was to evaluate the safety and efficacy of efbemalenograstim alfa versus filgrastim for neutropenia support in patients with breast cancer receiving myelosuppressive chemotherapy and find the recommended dose for phase III clinical trials.MethodsThis was an open-label, dose-finding, active-controlled, phase II study. In total, 138 patients with postoperative breast cancer received up to four cycles of epirubicin 100 mg/m2 + cyclophosphamide 600 mg/m2 (EC) chemotherapy. Patients were randomized in a 1:1:1 ratio to efbemalenograstim alfa (10 mg/dose or 20 mg/dose) or filgrastim group. Duration and incidence rate of moderate or severe neutropenia, depth of absolute neutrophil count (ANC) nadir, time to ANC recovery post nadir, and safety information were evaluated.ResultsThe mean duration of moderate and severe neutropenia in cycle 1 was 0.8, 0.6, and 0.8 days for the 10 mg/dose efbemalenograstim alfa, 20 mg/dose efbemalenograstim alfa, and filgrastim groups, respectively. The incidence rate of moderate and severe neutropenia in cycle 1 was lower in 20 mg/dose efbemalenograstim alfa (25.5%) than that in 10 mg/dose efbemalenograstim alfa (35.1%) and filgrastim (38.5%), and no significant differences were observed for the two doses of efbemalenograstim alfa with filgrastim (p = 0.815; p = 0.246, respectively). The ANC nadir occurred between days 9 and 10 in cycle 1, and the median ANC nadir in the 20 mg/dose efbemalenograstim alfa group was higher than that in the 10 mg/dose efbemalenograstim alfa and filgrastim groups (2.2 × 109/L versus 1.7 × 109/L and 1.4 × 109/L, respectively). The time to ANC recovery post nadir in the 20 mg/dose efbemalenograstim alfa group was shorter, but no significant differences were observed for the two doses of efbemalenograstim alfa with filgrastim (0.8 and 1.7 versus 1.2 days, respectively). Efbemalenograstim alfa exhibited similar safety profile to filgrastim. No febrile neutropenia occurred. The incidence rates of common adverse reactions related to the study drugs, such as back pain and bone pain, were lower in the efbemalenograstim alfa groups than that in the filgrastim group (10.3% and 8.0% versus 24.4%).ConclusionsThe efficacy and safety of efbemalenograstim alfa are comparable to those of filgrastim in treating chemotherapy-induced neutropenia in patients with breast cancer receiving EC chemotherapy. Efbemalenograstim alfa at a dose of 20 mg is the recommended dose for phase III clinical trials.Trial registrationClinicalTrials.gov: NCT02521441, on 13 August 2015.

Abstract licence: CC BY-NC