藥碼
TOP05
藥名
Topotecan HCl 4 mg/Vial
英文商品名
化療 Topotecan 針 4 mg
中文商品名
百博拓普康注射劑
螢幕名
化療 Topotecan 針 4 mg
劑型
Inj
規格
成分
藥理分類
Anticancer-Others
健保碼
BC26307219
ATC碼
藥品圖片
外觀圖片
適應症
Metastatic ovarian cancer after disease progression on or after chemotherapy, as a single agent; platinum-sensitive small cell lung cancer (SCLC) with progression 60 days after initiation of first-line chemotherapy, as a single agent; Stage IV-B, recurrent, or persistent cervical cancer not amenable to curative treatment, in combination with cisplatin.
藥理
Topotecan is a topoisomerase I inhibitor. It binds to the topoisomerase I-DNA complex and prevents re-ligation of single-strand DNA breaks, resulting in DNA damage and inhibition of tumor cell proliferation.
藥動學
Following IV administration, exposure is approximately dose-proportional.
Protein binding : ~35%.
Metabolism : reversible pH-dependent hydrolysis of the active lactone form; also metabolized to an N-demethylated metabolite.
Terminal half-life : approximately 2–3 hours.
Approximately 51% of total topotecan is excreted in urine and 18% in feces. Clearance is reduced with renal impairment.
禁忌症
History of severe hypersensitivity reactions to topotecan.
懷孕分類
Topotecan can cause embryo-fetal toxicity. Females of reproductive potential should use effective contraception during treatment and for 6 months after the last dose; males with female partners of reproductive potential should use effective contraception during treatment and for 3 months after the last dose.
哺乳分類
Breastfeeding is not recommended during treatment and for 1 week after the last dose, due to the potential for serious adverse reactions in breastfed infants.
副作用
Common/clinically important :
neutropenia, anemia, thrombocytopenia, febrile neutropenia, nausea, vomiting, fatigue, diarrhea, dyspnea, infection, and asthenia.

Serious :
severe myelosuppression, neutropenic enterocolitis (typhlitis), interstitial lung disease, and extravasation/tissue injury.
劑量和給藥方法
Ovarian cancer :
1.5 mg/m² IV over 30 minutes once daily for 5 consecutive days, starting on Day 1 of a 21-day cycle.

SCLC :
1.5 mg/m² IV over 30 minutes once daily for 5 consecutive days, starting on Day 1 of a 21-day cycle.

Cervical cancer :
0.75 mg/m² IV over 30 minutes on Days 1–3, with cisplatin 50 mg/m² on Day 1, every 21 days. Do not exceed a single dose of 4 mg.
小兒調整劑量
Safety and efficacy in pediatric patients have not been established.
腎功能調整劑量
Single-agent therapy :
  • For CrCl 20–39 mL/min, reduce dose to 0.75 mg/m²/day.
  • CrCl ≥ 40 mL/min: no dosage adjustment recommended.
  • Insufficient data are available for CrCl <20 mL/min.
  • 肝功能調整劑量
    No dosage adjustment required. No clinically significant differences in topotecan pharmacokinetics were observed with hepatic impairment.
    安定性
    After reconstitution: Use immediately; discard unused portion because the vial contains no preservative. After dilution for infusion: Store at approximately 20–25°C, protected from light, for ≤ 24 hours; discard after 24 hours.
    注射給藥指引
    給藥途徑

    靜脈輸注。

    Intravenous (IV) infusion.

    靜脈輸注液

    0.9% 氯化鈉 (NS) 靜脈輸注液或 5% 葡萄糖 (D5W) 靜脈輸注液。

    0.9% Sodium Chloride (NS) infusion or 5% Dextrose (D5W) infusion.

    每瓶稀釋液體積

    1 毫克小瓶應以 1.1 毫升無菌注射用水泡製;4 毫克小瓶應以 4 毫升無菌注射用水泡製。泡製後溶液每毫升含 1 毫克 topotecan。加入稀釋液後,達最終稀釋濃度25-50 mcg/mL

    Reconstitute the 1 mg vial with 1

    注射濃度
    給藥速率

    每次給藥應以 30 分鐘的時間靜脈輸注。

    安定性
    After reconstitution: Use immediately; discard unused portion because the vial contains no preservative. After dilution for infusion: Store at approximately 20–25°C, protected from light, for ≤ 24 hours; discard after 24 hours.
    注意事項
    在開始第一個療程前,病人的嗜中性白血球必須 ≥ 1.5 x 109/L,血小板 ≥ 100 x 109/L,且血紅素 ≥ 9g/dL

    1. 本藥品具細胞毒性,調劑與給藥應遵循化療安全處理規範。2. 外滲風險:本藥通常被視為刺激劑(Irritant),外滲可能導致組織發炎或損傷;若發生外滲,應立即停止輸注,保留針頭以抽回藥液,並依院內外滲處置流程進行(如冷敷)。3. 避光:未配製前的藥粉應儲存在原包裝中以避光;稀釋後的輸注液在一般室內光線下雖具穩定性,但在給藥期間仍建議避免直接強光照射。4. 無須使用特殊過濾器。5. 調劑後應檢查有無微粒或變色。

    1. This drug is cytotoxic; preparation and administration must follow hazardous drug handling procedures.
    2. Extravasation risk: Topotecan is generally considered an irritant; extravasation may cause tissue inflammation or injury. If extravasation occurs, stop infusion immediately, leave the needle in place to aspirate any remaining drug, and manage according to institutional protocols (e.g., cold compresses).
    3. Light protection : Vials of lyophilized powder should be stored in the original carton to protect from light. Diluted solutions are stable in ambient light, but exposure to direct strong light during administration should be avoided.
    4. No special filter is required.
    5. Inspect for particulate matter or discoloration after preparation.

    藥袋資訊
    臨床用途
    化學治療藥
    主要副作用
    貧血、厭食、腹瀉、噁心、嘔吐、無力、疲倦、發燒等
    泡製方法
    儲存方式
    請置於 15-30℃ 乾燥處儲存
    注意事項
    其他說明
    化療藥局 化6 | 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
    5551
    自費價
    6661.2
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