A 63-year-old male patient with diffuse large B-cell lymphoma (DLBCL) received a subcutaneous injection of 20 mg efbemalenograstim alfa 48 hours after chemotherapy with the "zuberitamab+CHOP" regimen to prevent neutropenia. Thirty minutes after administration, the patient suddenly developed symptoms such as dyspnea, pale complexion, cold and clammy limbs, and confusion. Monitoring showed a respiratory rate of 26 breaths per minute and an oxygen saturation of 90%, which was diagnosed as a grade 2 acute allergic reaction. Immediate oxygen therapy, intramuscular injection of 25 mg promethazine, and intravenous injection of 5 mg dexamethasone were given, and the symptoms were relieved. The drug was not used again in subsequent chemotherapy. Grade Ⅲ neutropenia occurred after the third cycle of chemotherapy, and the patient recovered after treatment with short-acting recombinant human granulocyte colony-stimulating factor. After MDT discussion in the fourth cycle, the regimen was adjusted to 6 mg pegylated recombinant human granulocyte colony-stimulating factor, and no adverse reactions were observed during administration. The Naranjo's Assessment Scale scored 7 points, determining a "probable" association between the allergic reaction and efbemalenograstim alfa. This case suggests that acute allergic reaction is a rare adverse reaction of efbemalenograstim alfa. This paper discusses its sensitization mechanism and the adjustment strategy of leukocyte-increasing drugs, providing practical reference for the safe clinical use of the drug.
1.Mithoowani S, Cameron L, Crowther MA. Neutropenia[J]. Can Med Assoc J, 2022, 194(49): E1689. DOI: 10.1503/cmaj.220499.
2.Lalami Y, Klastersky J. Impact of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN)on cancer treatment outcomes: an overview about well-established and recently emerging clinical data[J]. Crit Rev Oncol Hematol, 2017, 120: 163-179. DOI: 10.1016/j.critrevonc.2017.11.005.
3.中国抗癌协会肿瘤临床化疗专业委员会, 中国抗癌协会肿瘤支持治疗专业委员会. 肿瘤化疗导致的中性粒细胞减少诊治中国专家共识(2023版)[J]. 中华肿瘤杂志, 2023, 45(7): 575-583. [China Anti-Cancer Association Tumor Clinical Chemotherapy Professional Committee, China Anti-Cancer Association Tumor Support Therapy Professional Committee. Consensus on clinical diagnosis, treatment, and prevention of chemotherapy-induced neutropenia in China (2023 edition)[J]. Chinese Journal of Oncology, 2023, 45(7): 575-583]. DOI: 10.3760/cma.j.cn112152-20230224-00076.
4.Blair HA. Efbemalenograstim alfa: first approval[J]. Drugs, 2023, 83(12): 1125-1130. DOI: 10.1007/s40265-023-01911-7.
5.Glaspy J, Daley W, Bondarenko I, et al. A phase III, randomized, multi-center, open-label, fixed dose, neulasta active-controlled clinical trial of F-627, a novel G-CSF, in women with breast cancer receiving myelotoxic chemotherapy[J]. Blood, 2021, 138 (Supplement 1): 4290. https://doi.org/10.1182/blood-2021- 145760.
6.中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会(CSCO)抗肿瘤治疗所致中性粒细胞减少症诊断、预防和治疗指南2025[M]. 北京人民卫生出版社, 2025: 1-54.
7.FD. Qlik sense [EB/OL]. (2025-11-27) [2025-11-27]. https://fis.fda.gov/sense/app/95239e26-e0be-42d9-a960-9a5f7f1c25ee/sheet/6b5a135f-f451-45be-893d-20aaee34e28e/state/analysis.
8.Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions[J]. Clin Pharmacol Ther, 1981, 30(2): 239-245. DOI: 10.1038/clpt.1981.154.
9.Zhang Q, Wang Z, Yao W, et al. A randomized, multicenter phase III study of once-per-cycle administration of efbemalenograstim alfa (F-627), a novel long-acting rhG-CSF, for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer[J]. BMC Cancer, 2024, 24(1): 1143. DOI: 10.1186/s12885-024-12892-5.
10.Sethu S, Govindappa K, Alhaidari M, et al. Immunogenicity to biologics: mechanisms, prediction and reduction[J]. Arch Immunol Ther Exp (Warsz). 2012, 60(5): 331-344. DOI: 10.1007/s00005-012-0189-7.
11.Weiszhár Z, Czúcz J, Révész C,et al. Complement activation by polyethoxylated pharmaceutical surfactants: cremophor-EL, tween-80 and tween-20[J]. Eur J Pharm Sci, 2012, 45(4): 492-498. DOI: 10.1016/j.ejps.2011.09.016.
12.Kozuch B, Weber J, Buske J, et al. Comparative stability study of polysorbate 20 and polysorbate 80 related to oxidative degradation[J]. Pharmaceutics, 2023, 15(9): 2332. DOI: 10.3390/pharmaceutics15092332.
13.Yang Q, Jacobs TM, McCallen JD, et al. Analysis of pre-existing IgG and IgM antibodies against polyethylene glycol (PEG) in the general population[J]. Anal Chem, 2016, 88(23): 11804-11812. DOI: 10.1021/acs.analchem.6B03437.
14.Moore J. Final report on the safety assessment of polysorbates 20, 21, 40, 60, 61, 65, 80, 81 and 85[J]. J Am Coll Toxicol, 1984, 3: 1-82. DOI: 10.3109/10915818409042586.
15.Yokoe T, Yoshinami T, Nozawa K, Efficacy and safety of dose-dense chemotherapy for early-stage breast cancer under prophylactic pegfilgrastim administration: a systematic review and Meta-analysis from clinical practice guidelines for the use of G-CSF 2022[J]. Int J Clin Oncol. 2025, 30(4): 674-683. DOI: 10.1007/s10147-025-02716-2.
16.Kuderer NM, Dale DC, Crawford J, et al.Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: a systematic review[J]. J Clin Oncol, 2007, 25(21): 3158-3167. DOI: 10.1200/JCO.2006.08.8823.
17.Mishra P, Nayak B, Dey RK. PEGylation in anti-cancer therapy: an overview[J]. Asian J Pharm Sci, 2016, 11(3): 337-348. https://doi.org/10.1016/J.AJPS.2015.08.011.
18.Ibrahim M, Ramadan E, Elsadek NE, et al.Polyethylene glycol (PEG): the nature, immunogenicity, and role in the hypersensitivity of PEGylated products[J]. J Control Release, 2022, 351: 215-230. DOI: 10.1016/j.jconrel.2022.09.031.
19.姚明, 康吉云, 李昊洋, 等. 我国药学监护领域研究现状及趋势的可视化分析[J]. 数理医药学杂志, 2025, 38(1): 16-26. [Yao M, Kang JY, Li HY, et al. Visual analysis of the current research status and trends in the field of pharmaceutical care in China[J].Journal of Mathematical Medicine, 2025, 38(1): 16-26.] DOI: 10.12173/j.issn.1004-4337.202409024.