Pegfilgrastim 6mg/0.6ml solution for injection pre-filled disposable devices

OBJECTIVES: There is no meta-analysis about the effects of pegfilgrastim on the occurrence of febrile neutropenia (FN) in pediatric/adolescent cancer patients. The study explored the efficacy of prophylactic pegfilgrastim in preventing FN in children/adolescents with cancer. METHODS: PubMed, Embase, and the Cochrane Library were searched for studies published before April 7, 2020. The primary outcome was the rate of FN. Effect size (ES) and odds ratio (OR) with 95% confidence intervals (CIs) were used to evaluate the outcome. The ES represented the rate of FN, and the STATA 'metaprop' command was used to synthesize the rate. RESULTS: = 0.520). In patients receiving pegfilgrastim, the rate of FN was 25.6% (95% CI: 14.9%-36.3%), the rate of grade 4 FN was 38.3% (95% CI: 19.2%-59.5%), the rate of severe neutropenia (SN) was 40.5% (95% CI: 35.1%-46.1%), and the rate of treatment delays due to FN was 4.8% (95% CI: 0.8%-11.3%). DISCUSSION: The number of studies that could be included was small; therefore, a specific type of cancer or a specific treatment could be studied. Heterogeneity was high. CONCLUSION: There was no difference between pegfilgrastim and filgrastim for the rate of FN. The use of pegfilgrastim was still associated with rates of FN, grade 4 FN, severe neutropenia, and treatment delays due to FN in pediatric cancer patients.

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Abstract Purpose Evaluate the safety and efficacy of efbemalenograstim alfa for neutrophil support in breast cancer patients undergoing myelosuppressive chemotherapy in a phase 2, dose-finding, open-label study (NCT01648322, ClinicalTrials.gov, 2012–07-19). Methods 232 patients received up to 4 cycles of chemotherapy, 141 patients with docetaxel + cyclophosphamide (TC) and 91 patients with docetaxel + doxorubicin + cyclophosphamide (TAC). Patients were randomized to efbemalenograstim alfa (80, 240, or 320 µg/kg [TC]; 240 or 320 µg/kg [TAC]) or pegfilgrastim (6 mg) on Day 2 of each cycle. Results Efbemalenograstim alfa was non-inferior to pegfilgrastim in duration of moderate and severe neutropenia (absolute neutrophil count [ANC] < 1.0 × 10 9 /L) in TAC Cycle 1 (mean [SD] of 2.1 [1.58] and 2.1 [1.46] days for 240 µg/kg and 320 µg/kg efbemalenograstim alfa, respectively, and 1.8 [1.28] days for pegfilgrastim), with a difference (95% CI) of 0.3 (-0.4, 1.1) days. ANC nadir occurred between Days 7–8 of TAC Cycle 1, with mean [SD] of 0.68 [1.064], 0.86 [1.407] and 0.78[1.283] × 10 9 /L for 240 µg/kg, 320 µg/kg efbemalenograstim alfa and pegfilgrastim, respectively. Time to ANC recovery post nadir (defined as an ANC > 2.0 × 10 9 /L after the expected ANC nadir) was 2.0–2.4 and 1.9 days for TAC patients treated with efbemalenograstim alfa and pegfilgrastim, respectively. No significant difference was found between any dose of efbemalenograstim alfa and pegfilgrastim in TAC Cycle 1 for incidence of moderate to severe neutropenia (76%-77% of patients) or incidence of severe neutropenia (ANC < 0.5 × 10 9 /L; 63%-72%). Efbemalenograstim alfa exhibited similar safety profile to pegfilgrastim. Febrile neutropenia occurred in 4 (1.8%) patients, 2 patients each for 320 µg/kg efbemalenograstim alfa and pegfilgrastim, with no event considered related to study drug. Conclusion Efbemalenograstim alfa was comparable to pegfilgrastim in efficacy and safety. ClinicalTrials.gov identifier NCT01648322.

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PURPOSE This phase III noninferiority (NI) trial evaluated the efficacy and safety of efbemalenograstim alfa, a novel non-PEGylated, long-acting, human granulocyte-colony stimulating factor for the management of chemotherapy-induced neutropenia (CIN), in patients with breast cancer. MATERIALS AND METHODS Adult patients with stage I-III invasive breast cancer (n = 393) undergoing docetaxel and cyclophosphamide chemotherapy treatment were randomly assigned (1:1) to receive a single fixed dose of efbemalenograstim alfa or pegfilgrastim 24 hours after each chemotherapy administration. The primary objective was to demonstrate NI or potential superiority of efbemalenograstim alfa compared with pegfilgrastim. The primary end point is the duration of severe neutropenia (DSN) in cycle 1 with a NI margin of 0.6 days. Additional end points included incidence of severe neutropenia (ISN), febrile neutropenia, infections, and incidence of treatment-emergent adverse events (TEAEs). RESULTS Among patients randomly assigned to efbemalenograstim alfa (n = 197), the mean DSN in cycle one was 0.2 ± 0.51 days, compared with 0.2 ± 0.45 days for the pegfilgrastim group (n = 196), with a CI of –0.1 to 0.1 days ( P = .7) for the treatment comparison, confirming NI. There was a lower ISN in those receiving efbemalenograstim alfa at cycle 4 ( P = .050). Lower ISN in later cycles was observed in all three efbemalenograstim alfa phase III trials. Treatment with efbemalenograstim alfa was safe, with low incidences of serious AEs and TEAEs, and an overall safety profile comparable with the pegfilgrastim group. Similar to ISN, fewer grade 4 neutropenias in the efbemalenograstim alfa group were observed compared with pegfilgrastim. CONCLUSION Results demonstrated that efbemalenograstim alfa was noninferior to current CIN therapy (pegfilgrastim) with comparable efficacy and safety profiles in cycle 1 and showed evidence of less neutropenia in later cycles.

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INTRODUCTION: Myelosuppression, a challenge in cancer treatment, often results in severe complications. Prophylactic granulocyte colony-stimulating factors, particularly pegfilgrastim, mitigate chemotherapy-induced neutropenia. This narrative review evaluates the role of on-body injector (OBI) devices for pegfilgrastim administration. A comprehensive search strategy of PubMed and AI-powered intuitive search tools, complemented by authors' contributions, yielded a body of papers presenting evidence on OBI devices, their effectiveness and safety, the benefits and challenges of OBI versus pre-filled syringe administration, patient preferences for pegfilgrastim administration, and economic considerations. DISCUSSION: OBI devices prove effective and safe, with advantages such as reduced clinic visits and enhanced adherence. Studies highlight cost-efficiency and expanded access, emphasizing the socioeconomic context. Patient and provider preferences underscore the potential of OBI devices in cancer care, with implications for healthcare resource utilization and pharmacoeconomics. CONCLUSION: The value proposition of OBI devices lies in improving patient outcomes, convenience, resource optimization, and enhancing the overall cancer care experience. As biosimilar OBIs enter the market, they may offer cost savings, further influencing their adoption and their positioning as a cost-efficient alternative in cancer care. Ongoing research and technological advancements are expected to contribute to the broader acceptance of OBI devices in cancer care delivery.

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Abstract The increasing risks of ionizing radiation (IR) from deep space travel and nuclear accidents necessitate the development of effective countermeasures. Acute radiation syndrome (ARS), particularly hematopoietic ARS (H‐ARS), leads to life‐threatening anemia and bone marrow failure, with long‐term risks including cancer and cardiovascular disease. This study presents phenylboronic acid‐functionalized chitosan‐polyethylenimine (CPB) polymers designed for efficient oral delivery of pegfilgrastim (PF), an FDA‐approved radioprotective agent. Nanoparticles are prepared through complexation of PF with tannic acid, forming a negatively charged core, followed by encapsulation with a CPB polymer shell. This supramolecular strategy enables efficient protein condensation into uniform nanoparticles. The nanosystem effectively reduces H‐ARS‐associated anemia in mice by promoting blood cell reconstitution, supported by in vitro results with human hematopoietic stem/progenitor cells. Additionally, the material reduces toll‐like receptor activation in multiple human cell types post‐radiation. This system may mitigate radiation injury risks from accidental exposure on Earth and during extended space missions.

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BACKGROUND: Pegfilgrastim is widely used for the prevention of febrile neutropenia (FN) in patients receiving myelosuppressive chemotherapy for various types of cancer. However, pegfilgrastim-induced bone pain (PIBP) is a relevant adverse event occurring during cancer treatment. Thus, we aimed to determine the risk factors for PIBP in real-world clinical practice. MAIN BODY: We retrospectively collected the clinical records of patients who received pegfilgrastim to support myelosuppressive chemotherapy with at least a 10% risk of FN between 2015 and 2018 at our center. Patients received pegfilgrastim 3.6 mg between days 2 and 7 after chemotherapy administration (day 1) for primary or secondary prophylaxis against FN. All adverse events were recorded according to the Common Terminology Criteria for Adverse Events. Patients who experienced intermittent bone pain in the back, femur, or other anatomic sites after the pegfilgrastim administration were considered to have PIBP. To evaluate the relationship between PIBP incidence and patient characteristics, we performed univariate and multivariate logistic regression analyses to calculate the odds ratios (ORs) of possible risk factors for PIBP. We analyzed the data of 305 patients (median age: 63 years), who underwent 1220 chemotherapy cycles with pegfilgrastim per cycle. Univariate analysis revealed that female sex (vs. male sex), younger age (< 55 years vs. ≥ 55 years), and solid cancers (vs. hematologic cancers) had significantly higher ORs (p < 0.05). However, only younger age (< 55 years) was an independent risk factor for PIBP on multivariate analysis (OR 3.62, 95% confidence interval 1.51-8.69, p = 0.004). CONCLUSIONS: Younger age (< 55 years) was significantly associated with a higher risk of PIBP among patients receiving chemotherapy with a ≥ 10% risk of FN. Therefore, oncologists should meticulously formulate management plan for PIBP in younger patients after administering pegfilgrastim.

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