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Case 8
Published in Andrew Solomon, Julia Anstey, Liora Wittner, Priti Dutta, Clinical Cases, 2021
Andrew Solomon, Julia Anstey, Liora Wittner, Priti Dutta
There are four different versions of G-CSF currently available on the UK market: filgrastim, lenograstim, lipegfilgrastim and pegfilgrastim. They are given via subcutaneous injection, subcutaneous infusion or intravenous infusion.
Nucleic Acids as Therapeutic Targets and Agents
Published in David E. Thurston, Ilona Pysz, Chemistry and Pharmacology of Anticancer Drugs, 2021
Carboplatin is less potent than cisplatin and for this reason is normally administered intravenously in a 4:1 ratio compared to cisplatin for a similar clinical scenario (i.e., four times more carboplatin is needed to achieve the same efficacy). It is better tolerated than cisplatin, and so it is more often used on an outpatient basis. In particular, nausea and vomiting are reduced in severity, and nephrotoxicity, neurotoxicity, and ototoxicity are much less pronounced. However, it is more myelosuppressive than cisplatin and can cause the blood cell and platelet output of bone marrow in the body to decrease dramatically, sometimes to as low as 10% of its usual levels. The nadir of this myelosuppression usually occurs 21–28 days after the first treatment, after which the blood cell and platelet levels in the blood begin to stabilize, often reaching close to pre-treatment levels. This decrease in white blood cells (neutropenia) can cause complications such as an increased probability of infection by opportunistic organisms, which can necessitate re-admission to hospital and treatment with antibiotics. The neutropenia is sometimes treated with human granulocyte-colony stimulating factors (G-CSFs) such as filgrastim, lenograstim, pegfilgrastim, or lipegfilgrastim.
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Published in Caroline Ashley, Aileen Dunleavy, John Cunningham, The Renal Drug Handbook, 2018
Caroline Ashley, Aileen Dunleavy, John Cunningham
Lipegfilgrastim is metabolised via intra- or extracellular degradation by proteolytic enzymes. It is internalised by neutrophils (non-linear process), then degraded within the cell by endogenous proteolytic enzymes. The linear pathway is likely due to extracellular protein degradation by neutrophil elastase and other plasma proteases.
Prophylaxis of chemotherapy-induced neutropenia with lipegfilgrastim in patients with lung cancer: final results from the non-interventional study NADIR
Published in Current Medical Research and Opinion, 2022
Christian Geßner, Thomas Fietz, Christoph Losem, Andreas Lück, Holger Schulz, Beate Niemeier, Matthias Groschek, Henning Eschenburg, Rudolf Weide, Albrecht Kretzschmar, Nikolaj Frost, Joachim Hipp, Johanna Harde, Christiane D. Matillon, Sina Grebhardt, Karin Potthoff
The primary study objective was to evaluate the effectiveness of lipegfilgrastim. Incidences of severe neutropenia, defined as neutropenia NCI-CTCAE grade 3/4 according to the National Cancer Institute Common Terminology Criteria for Adverse Events, incidences of FN (as defined by current guidelines4) and incidences of neutropenia-associated complications were assessed. Secondary objectives included the intention and timing of lipegfilgrastim administration, patients´ individual risk to develop FN and the incidence of AEs. Intention of lipegfilgrastim application was determined at the discretion of respective treating physician, according to following guidelines: (1) primary prophylaxis: lipegfilgrastim application was planned with choice of chemotherapy and was part of the first chemotherapy cycle, aiming to prevent neutropenia associated complications and/or to comply with planned chemotherapy intervals; (2) secondary prophylaxis: lipegfilgrastim was not used in the prior chemotherapy cycle; however, the patient developed (febrile) neutropenia in the previous treatment cycle; therefore, lipegfilgrastim was applied as planned part of the subsequent chemotherapy cycles; (3) therapeutic intervention: during the current chemotherapy cycle neutropenia associated complications or severe neutropenia occurred, resulting in immediate intervention with lipegfilgrastim in order to rapidly increase the neutrophil count.
Prescribing patterns from medical chart abstraction of patients administered lipegfilgrastim: a pilot study in Europe
Published in Journal of Drug Assessment, 2019
Sigal Kaplan, Nicole Lang, Maja Gasparic, Carolyn Rainville, George Haralabopoulos, Emanuele Borroni
Based on the study results, the data collection and screening tools (initial survey questionnaire, and SRQ) used in this study were found to be useful and informative about the availability of the relevant medical data and the use of two independent abstractors within a center. Overall, lipegfilgrastim was prescribed according to the indications in the SmPC. It was prescribed to adult patients treated with cytotoxic chemotherapy for malignancy, the majority of whom had breast cancer. In most first treatment cycles, lipegfilgrastim was indicated for the prevention of neutropenia. During this cycle, lipegfilgrastim was administered according to the indicated age, dose, and route of administration; in a small proportion of records (15.2%), drug administration was not consistent with the dosing instructions of the SmPC. On-label use was documented in the majority of records and Type IV off-label use (use in patients treated with non-cytotoxic drugs) was estimated at 4.3% (two patients from a single center in the Netherlands). The high overall agreement between the abstractors suggests that the CRF was robust and reliable for collecting the necessary data on lipegfilgrastim use.
Effect of lipegfilgrastim administration as prophylaxis of chemotherapy-induced neutropenia on dose modification and incidence of neutropenic events: real-world evidence from a non-interventional study in Belgium and Luxembourg
Published in Acta Clinica Belgica, 2021
Christel Fontaine, Nele Claes, Marie-Pascale Graas, Khalil Kargar Samani, Peter Vuylsteke, Christof Vulsteke
The sample size was estimated based on feasibility considerations in the entire European population. A size of 125 patients was foreseen for Belgium/Luxembourg. Analyses were carried out on the safety set (all patients receiving at least 1 dose of lipegfilgrastim) and efficacy set (all patients from the safety set for whom at least 1 cycle with lipegfilgrastim has been evaluated in the next cycle). The incidence of neutropenia was assessed in all cycles in which lipegfilgrastim was received.