轉移性乳癌、非小細胞肺癌、胰腺癌Breast cancer, metastatic: Treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy Non-small cell lung cancer, locally advanced or metastatic: First-line treatment of locally advanced or metastatic NSCLC (in combination with carboplatin) in patients who are not candidates for curative surgery or radiation therapy Pancreatic adenocarcinoma, metastatic: First-line treatment of metastatic adenocarcinoma of the pancreas (in combination with gemcitabine)
藥理
Antineoplastic Agent, Antimicrotubular; Taxane Derivative Paclitaxel (protein bound) is an albumin-bound paclitaxel nanoparticle formulation; paclitaxel promotes microtubule assembly by enhancing the action of tubulin dimers, stabilizing existing microtubules, and inhibiting their disassembly, interfering with the late G2 mitotic phase, and inhibiting cell replication.
藥動學
Distribution: 1. Vd: 1741 L (extensive extravascular distribution and/or tissue binding) 2. Protein binding: 94% Metabolism: 1. Hepatic primarily via CYP2C8 to 6-alpha-hydroxypaclitaxel; also to minor metabolites via CYP3A4 2. Half-life elimination: Terminal: 13 to 27 hours Excretion: 1. Feces (~20%); urine (4% as unchanged drug, <1% as metabolites) 2. Clearance: 13 to 30 L/hour/m2
禁忌症
1. Baseline neutrophil count of <1,500/mm3 2. History of severe hypersensitivity reaction to paclitaxel (protein bound) or any component of the formulation
懷孕分類
Based on the mechanism of action and on findings in animal reproduction studies, paclitaxel (protein bound) may cause fetal harm if administered during pregnancy.
哺乳分類
Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends patients not breastfeed during therapy and for 2 weeks following the last paclitaxel (protein bound) dose.
Breast cancer, metastatic: IV: 260 mg/m2 every 3 weeks NSCLC, locally advanced or metastatic: IV: 100 mg/m2 on days 1, 8, and 15 of each 21-day cycle (in combination with carboplatin) Pancreatic adenocarcinoma, metastatic: IV: 125 mg/m2 on days 1, 8, and 15 of a 28-day cycle (in combination with gemcitabine)
小兒調整劑量
腎功能調整劑量
1. CrCl ≥30 mL/minute: No dosage adjustment necessary 2. CrCl <30 mL/minute, ESRD: There are no dosage adjustments provided in the manufacturer's labeling (insufficient data)
肝功能調整劑量
Impairment
AST levels
-
Bilirubin levels
Dose: Breast cancer
Dose: NSCLC
Dose: Pancreatic adenocarcinoma
Mild
≤10xULN
and
>ULN to ≤1.5xULN
260 mg/m2
100 mg/m2
125 mg/m2
Moderate
≤10xULN
and
>1.5 to ≤3xULN
200 mg/m2
80 mg/m2
Not recommended
安定性
注射給藥指引
給藥途徑
IV
靜脈輸注液
不須稀釋
每瓶稀釋液體積
不須稀釋
注射濃度
給藥速率
Administer over 30 minutes (breast cancer and non-small cell lung cancer [NSCLC]) or over 30 to 40 minutes (pancreatic cancer).