L03AA13 pegfilgrastim
ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ›IMMUNOSTIMULANTS ›IMMUNOSTIMULANTS ›Colony stimulating factors
健保收載品項 FDA 已核准 TFDA 在效許可證 3 健保給付條款 1
健保收載品名：倍血添注射劑、福富血注射劑、血添佐注射劑
FDA 適應症
1 INDICATIONS AND USAGE ZIEXTENZO is a leukocyte growth factor indicated to • Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1.1 ) • Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). ( 1.2 ) Limitations of Use ZIEXTENZO is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy ZIEXTENZO is indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies ( 14.1 )]. Limitations of Use ZIEXTENZO is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome ZIEXTENZO is indicated to increase survival in adults and pediatric patients aged newborn and older acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration ( 2.2 ) and Clinical Studies ( 14.2 )].
資料來源：openFDA（美國 FDA Structured Product Labeling）。為英文原文，僅供對照。
TFDA 適應症
適應症（去重後 3 項）：
- 適用於非骨髓性癌症患者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、以降低嗜中性白血球減少症合併發燒為表現之感染發生率。
- 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、以降低嗜中性白血球減少症合併發燒為表現之感染發生率。
- 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、以降低嗜中性百血球減少症合併發燒為表現之感染發生率。
資料來源：食藥署「西藥許可證」＋「藥品 ATC 碼」＋「藥品仿單或外盒」＋「藥品外觀」開放資料。
NHI 給付規定
直接適用條款
§ 4.1.2.2 長效型注射劑(如pegfilgrastim)：(101/6/1、112/10/1、113/11/1、
血液治療藥物 › 造血功能治療藥物
長效型注射劑(如pegfilgrastim)：(101/6/1、112/10/1、113/11/1、114/9/1) 1.限非骨髓性癌症病人(不限合併有骨髓侵犯)，在骨髓抑制性抗癌藥物治療後，且曾經發生白血球少於1000/cumm，或嗜中性白血球(ANC)少於500/cumm者使用。(112/10/1、113/11/1、114/9/1) 2.同一化學治療療程內限用1支，亦不可併用短效型注射劑。(112/10/1)
歷史演變（4 次異動）
| 生效日 | 異動說明 |
|---|---|
| 101/6/1 | legacy_boan_parsed:ch04.txt |
| 112/10/1 | legacy_boan_parsed:ch04.txt |
| 113/11/1 | legacy_boan_parsed:ch04.txt |
| 114/9/1 | legacy_boan_parsed:ch04.txt |
實證補充
本藥品尚無實證補充整理（未來新增 Review／指引知識時補列）。
FDA 段：openFDA US SPL · TFDA 段：食藥署西藥許可證＋ATC 分類開放資料 · NHI 段：健保署「全民健康保險藥品給付規定」（更新日 2026-05-31）· 實證補充段：人工彙整。 本頁為資訊整理，實際給付與適應症以主管機關公告為準。