適用於非骨髓性癌症病人在接受易引起臨床上有顯著發生率的嗜中性白血球減少症合併發燒之骨髓抑制性抗癌藥物治療時,以降低感染發生率。Ziextenzo 不可用於造血幹細胞移植時動員周邊血液前驅細胞。
Indicated to reduce the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. Ziextenzo is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Pegfilgrastim 為一種重組人類 G-CSF 衍生物,可刺激造血細胞的增生與分化,藉由與特定細胞表面受體結合,促進嗜中性白血球的生長與活化。
Pegfilgrastim is a recombinant human G-CSF derivative that stimulates proliferation and differentiation of hematopoietic cells by binding to specific cell surface receptors, promoting neutrophil growth and activation.
Pegfilgrastim 在癌症病人中的藥物動力學呈非線性,主要經由與嗜中性白血球受體結合後清除,半衰期約15至80小時。腎功能障礙對其藥物動力學無顯著影響。
In cancer patients, pegfilgrastim exhibits nonlinear pharmacokinetics, with clearance primarily mediated by neutrophil receptor binding. The half-life ranges from 15 to 80 hours. Renal impairment does not significantly affect its pharmacokinetics.
對 pegfilgrastim 或 filgrastim 有嚴重過敏反應病史者禁用。
Contraindicated in patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.
懷孕婦女使用 pegfilgrastim 的資料有限。動物研究顯示高劑量下有胚胎毒性,使用時應權衡潛在效益與風險。
There are limited data on pegfilgrastim use in pregnant women. Animal studies have shown embryo-fetal toxicity at high doses. Pegfilgrastim should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
尚無 pegfilgrastim 分泌至人乳的資料。其他 filgrastim 藥品極少量分泌至乳汁且嬰兒口服吸收量低,使用時應考量哺乳益處與潛在風險。
There are no data on the presence of pegfilgrastim in human milk. Other filgrastim products are secreted in very small amounts, and oral absorption by infants is unlikely. The benefits of breastfeeding should be weighed against potential risks.
常見副作用包括骨痛和四肢痛。其他嚴重不良反應有脾臟破裂、急性呼吸窘迫症候群、嚴重過敏反應、腎絲球腎炎、微血管滲漏症候群及白血球增多。
Common adverse reactions include bone pain and limb pain. Serious adverse reactions include splenic rupture, acute respiratory distress syndrome (ARDS), severe allergic reactions, glomerulonephritis, capillary leak syndrome, and leukocytosis.
成人建議劑量為每個化療週期單次皮下注射 6 mg。不得在細胞毒性化療前14天內或化療後24小時內給藥。
The recommended adult dose is a single subcutaneous injection of 6 mg per chemotherapy cycle. Do not administer within 14 days before or 24 hours after cytotoxic chemotherapy.
小於18歲患者的安全性與有效性尚未確立,不建議使用固定劑量6 mg劑型。
Safety and efficacy in pediatric patients under 18 years of age have not been established. Fixed 6 mg dosing is not recommended in this population.
腎功能不全不影響 pegfilgrastim 的藥物動力學,無需調整劑量。
Renal impairment does not significantly affect the pharmacokinetics of pegfilgrastim, and no dose adjustment is required.
pegfilgrastim 的代謝主要依賴嗜中性白血球清除,無需因肝功能不全調整劑量。
Pegfilgrastim clearance primarily depends on neutrophil-mediated mechanisms; no dose adjustment is necessary for hepatic impairment.