藥碼
PHE06
藥名
Pertu-/Trastu- 皮下 1200/600
英文商品名
臨採化 Phesgo 皮下針 1200/600
中文商品名
賀雙妥皮下注射劑 1200/600毫克
螢幕名
臨採化 Phesgo 皮下針 1200/600
劑型
Inj
規格
成分
藥理分類
Anticancer- Monoclonal antibodies
健保碼
KC01172235
ATC碼
藥品圖片
外觀圖片
適應症
#高警訊藥品

Breast cancer, early, HER2 positive (adjuvant or neoadjuvant therapy): Neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (either >2 cm in diameter or node positive), in combination with chemotherapy, as part of a complete treatment regimen for early breast cancer in adults; adjuvant treatment of HER2-positive early breast cancer, in combination with chemotherapy, in adults at high risk of recurrence.
Breast cancer, metastatic, HER2 positive: Treatment of HER2-positive metastatic breast cancer (in combination with docetaxel) in adults who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
藥理
Antineoplastic Agent, Anti-HER2; Monoclonal Antibody
Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular HER2 protein dimerization domain. It inhibits HER2 dimerization and blocks HER downstream, signaling halting cell growth and initiating apoptosis.
藥動學
  • Distribution: SUBQ: Vd: Pertuzumab: 2.8 L; Trastuzumab: 2.9 L.
  • Bioavailability: Absolute: SUBQ: Pertuzumab: (0.71); Trastuzumab (0.77).
  • Half-life elimination: SUBQ: Pertuzumab: 24 days; Trastuzumab: 22 days.
  • Time to peak: SUBQ: Pertuzumab and Trastuzumab: 3.8 days.
  • Excretion: Clearance: SUBQ: Pertuzumab: 0.2 L/day; Trastuzumab (linear): 0.1 L/day.
  • 禁忌症
    Known hypersensitivity to pertuzumab, trastuzumab, or hyaluronidase, or any component of the formulation.
    懷孕分類
    D; Pertuzumab and trastuzumab are humanized monoclonal antibodies. Human IgG crosses the placenta.
    Based on outcome data from postmarketing reports and animal data, in utero exposure to pertuzumab/trastuzumab/hyaluronidase may cause fetal harm, including neonatal death and major birth defects.
    哺乳分類
    According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
    副作用
    Alopecia (77%), constipation (22%), diarrhea (17%-60%), nausea (60%), stomatitis (15%-25%), vomiting (20%), anemia (36%), decreased absolute lymphocyte count (89%), decreased platelet count (27%), neutropenia (22%), Increased serum alanine aminotransferase (58%), increased serum aspartate aminotransferase (50%), myalgia (25%), increased serum creatinine (84%).
    劑量和給藥方法
    Initial loading dose: SUBQ: Pertuzumab 1,200 mg/trastuzumab 600 mg/hyaluronidase 30,000 units initially, followed 3 weeks later by maintenance dosing.
    Maintenance dosing: SUBQ: Pertuzumab 600 mg/trastuzumab 600 mg/hyaluronidase 20,000 units once every 3 weeks. (Following surgery) for a total of 1 year (up to 18 cycles) or until disease progression or unacceptable toxicity, whichever occurs first.
    小兒調整劑量
    腎功能調整劑量
    There are no dosage adjustments provided in the manufacturer's labeling.
    肝功能調整劑量
    There are no dosage adjustments provided in the manufacturer's labeling.
    安定性
    1. Store intact vials at 2°C to 8°C; do not freeze.
    2. Store in the original carton to protect from light. Do not shake.
    3. If syringe prepared for administration is not used immediately, store the syringe refrigerated at 2°C to 8°C (do not freeze) for up to 24 hours and at room temperature at 20°C to 25°C for up to 4 hours; avoid unnecessary storage.
    藥袋資訊
    臨床用途
    早期乳癌、轉移性乳癌
    主要副作用
    高血壓、心律不整、呼吸困難、噁心、疲倦、皮疹、腹瀉
    泡製方法
    儲存方式
    請置於 2-8℃ 避光冷藏儲存
    注意事項
    其他說明
    化療藥局 化冰8 | 藥庫 化療
    藥品外觀
    顏色
    形狀
    剝痕
    標記1
    標記2
    其他
    健保藥價
    114562
    自費價
    126018.2
    仿單
    資料庫
    健保給付規定