Abstract
Simple SummaryThe most commonly reported adverse drug reactions (ADRs) related to filgrastim (FIL) and pegfilgrastim (PEG-F) were obtained and analyzed from the European EudraVigilance (EV) database. Frequently reported ADRs for FIL and PEG-F are pyrexia, bone pain, back pain, neutropenia and febrile neutropenia. No statistical difference in the probability of bone pain between FIL and PEG-F was observed. To further depict the safety of FIL and PEG-F, there is a further need to examine the real-life data.The primary prophylaxis with filgrastim (FIL) and pegfilgrastim (PEG-F) is recommended to decrease the severity of chemotherapy-induced neutropenia (CIN). The commonly reported adverse drug reactions (ADRs) with FIL and PEG-F is bone pain. ADRs pertaining to FIL and PEG-F were extracted from the European EudraVigilance (EV) database. The Individual Case Safety Reports (ICSRs) obtained from EV database that reported FIL and PEG-F as the suspected drug were analyzed. Registered ADRs (from the groups “General disorders and administration site conditions”, “Blood and lymphatic system disorders”, “Musculoskeletal and connective tissue disorders” and “Investigations”) for FIL and PEG-F were collected from EV database from 2007 to 5 June 2021. The reporting odds ratio (ROR) was used to calculate ICSRs with most common ADRs related to FIL and PEG-F. A total of 17,403 ICSRs described the incidence of most common ADRs of FIL and PEG-F. The commonly reported ADRs for both drugs were pyrexia, bone pain, back pain, neutropenia and febrile neutropenia. The odds ratio of ICSRs belonging to the System Organ Class (SOC) “Investigations” (ROR 1.01 (CI 0.93–1.10)) revealed no significant difference in FIL and PEG-F. However, for the SOCs (General disorders and administration site conditions” and “Musculoskeletal and connective tissue disorders” ((ROR 1.14 (CI 1.06–1.21); ROR 1.21 (CI 1.18–1.32), respectively), an increased reporting probability with PEG-F was found. The authors reported a lower reporting probability for the SOC “Blood and lymphatic system disorders” for FIL versus PEG-F (ROR 0.75 (CI 0.70–0.80)). Our results have demonstrated that the occurrence of bone pain was similar with FIL and PEG-F. For the incidence of pyrexia and back pain, PEG-F was associated with a higher reporting probability as compared to FIL. However, the incidence of neutropenia and febrile neutropenia was higher in FIL compared to PEG-F. Further evaluation of data from real life is needed.
Highlights
Neutropenia and its complications, including febrile neutropenia (FN), mainly caused by cancer chemotherapy, can result in sepsis and infection, leading to oncologic emergency [1,2]
The descriptive analysis of safety reports related to FIL and PEG-F were carried out using the EV database
Our results demonstrated the similar occurrence of bone pain in patients administered with FIL and PEG-F
Summary
Neutropenia and its complications, including febrile neutropenia (FN), mainly caused by cancer chemotherapy, can result in sepsis and infection, leading to oncologic emergency [1,2]. FN leads to a significant neutrophilic reduction accompanied by fever and is defined internationally as “an oral temperature of >38.3 ◦ C or two consecutive readings of. The prevention and correct management of FN is important because the rate of major complications (e.g., acute renal failure, hypotension, and heart failure) is approximately 25% to 30% and FN mortality rate ranges from 9% to. The severe sepsis and hospital mortality may be as high as 50%. FN results in decreasing dose, treatment delay or treatment cessation [5].
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