藥碼
END03
藥名
Cyclophosphamide 500 mg/Vial
英文商品名
化療 Endoxan 針 500 mg/Vial
中文商品名
癌得星注射劑 500 mg
螢幕名
化療 Endoxan 針 500 mg/Vial
劑型
Inj
規格
Cyclophosphamide 500 mg/Vial
成分
藥理分類
Anticancer-Nitrogen Mustards
健保碼
BC21304277
ATC碼
藥品圖片
外觀圖片
適應症
藥劑部參考美國 Johns Hopkins 大學研究團隊所建立的 NxP (Nephrotoxic Potential) 專家共識分級清單,本品具「顯著以上腎毒性風險」,被認定具中度至高度腎損傷潛勢,特別是同時合併其他腎毒性藥物、脫水、高齡或既有腎功能異常的患者族群,應更加注意。

淋巴性白血病、散發性腫瘤、慢性淋巴白血病、骨髓性淋巴病、淋巴肉芽腫及各種網狀組織細胞增多症,防止腫瘤復發。
藥理
Antineoplastic Agent, Alkylating Agent; Antineoplastic Agent, Alkylating Agent (Nitrogen Mustard); Antirheumatic, Miscellaneous; Immunosuppressant Agent.
藥動學
Distribution: Vd: 30 to 50 L; crosses into CSF.
Protein binding: ~20%; some metabolites are bound at >60%.
Metabolism: Hepatic to active metabolites acrolein, 4-aldophosphamide, 4-hydroperoxycyclophosphamide, and nor-nitrogen mustard.
Bioavailability: >75%.
Half-life elimination: 3 to 12 hours.
Time to peak: Metabolites: 2 to 3 hours.
Excretion: Urine (10 to 20% as unchanged drug); feces (4%).
禁忌症
History of severe hypersensitivity to cyclophosphamide, its metabolites, or any component of the formulation; urinary outflow obstruction, severe myelosuppression, severe renal or hepatic impairment, active infection (especially varicella zoster), severe immunosuppression.
懷孕分類
D; Cyclophosphamide crosses the placental barrier. Treatment with cyclophosphamide has a genotoxic effect and may cause fetal damage when administered to pregnant women.
哺乳分類
Cyclophosphamide and its metabolites are present in breast milk.
副作用
1. Bone marrow suppression and infection: leukopenia, neutropenia, thrombocytopenia, and anemia.
2. Cardiotoxicity: arrhythmias (supraventricular cardiac arrhythmia and ventricular arrhythmia), heart failure, heart block, hemopericardium, myocarditis, pericarditis, pericardial effusion including cardiac tamponade, and tachyarrhythmias.
3. Hemorrhagic cystitis: pyelitis, ureteritis, and hematuria, bladder fibrosis, necrosis or contracture.
4. Hepatotoxicity: hepatic sinusoidal obstruction syndrome, unexplained weight gain, ascites, hepatomegaly, cholestatic hepatitis or cytolytic hepatitis.
5. Pulmonary toxicity: pneumonitis, pulmonary fibrosis, pulmonary veno-occlusive disease, and acute respiratory distress syndrome.
6. Second primary malignancy: acute leukemia, bladder carcinoma, malignant lymphoma, malignant neoplasm of thyroid, myelodysplastic syndrome, sarcoma.
劑量和給藥方法
Continuous treatment: 3 to 6 mg/kg body weight daily (equivalent to 120 to 240 mg/m2 body surface).
Intermittent treatment: 10 to 15 mg/kg body weight (equivalent to 400 to 600 mg/m2 body surface) at intervals of 2 to 5 days.
High-dose intermittent treatment: 20 to 40 mg/kg body weight (equivalent to 800 to 1600 mg/m2 body surface) and higher doses (e.g. for conditioning prior to bone-marrow transplantation) at intervals of 21 to 28 days.
In adults with cancer with a BMI ≥30 kg/m2:
Cy200 (cyclophosphamide total dose of 200 mg/kg): Use the lesser of IBW or actual body weight (ABW).
Cy120 (cyclophosphamide total dose of 120 mg/kg): Use either IBW (preferred) or ABW for patients ≤ 120% IBW. Use ABW25 for patients >120% IBW.
[ABW25: Adjusted wt (kg) = Ideal body weight (kg) + 0.25 [actual wt (kg) - ideal body weight (kg)]]
Recommendations for dose reduction in patients with myelosuppression:
Leukocyte count [μl] Platelet count [μl] Dosage
> 4,000 > 100,000 100% of the planned dose
4,000 ~ 2,500 100,000 ~ 50,000 50% of the planned dose
< 2,500 < 50,000 Adjustment until values normalize or specific decision is made
小兒調整劑量
腎功能調整劑量
CrCl ≥10 mL/minute: no dosage adjustment required.
CrCl <10 mL/minute: administer 75% of normal dose.
Hemodialysis: moderately dialyzable (20% to 50%); administer 50% of normal dose; administer after hemodialysis.
Continuous ambulatory peritoneal dialysis (CAPD): administer 75% of normal dose.
Continuous renal replacement therapy (CRRT): administer 100% of normal dose.
肝功能調整劑量
Serum bilirubin 3.1 to 5 mg/dL or transaminases >3 times ULN: administer 75% of dose.
Serum bilirubin >5 mg/mL: avoid use.
安定性
注射給藥指引
給藥途徑

靜脈注射、靜脈輸注。

Intravenous (IV) injection or infusion.
靜脈輸注液

0.9% 生理食鹽水、5% 葡萄糖液、5% 葡萄糖生理食鹽水、乳酸林格氏液。

0.9% Sodium Chloride, 5% Dextrose, 5% Dextrose and 0.9% Sodium Chloride, Lactated Ringer's Solution.
每瓶稀釋液體積

每 100 毫克藥粉加入 5 毫升注射用水或生理食鹽水,使其最終濃度為 20 毫克/毫升。振搖後應呈澄清溶液。

Reconstitute each 100 mg vial with 5 mL of Sterile Water for Injection or 0.9% Sodium Chloride t
注射濃度
給藥速率

靜脈注射應緩慢進行(約 3 至 5 分鐘)。若為靜脈輸注,通常建議在 30 至 60 分鐘內完成,具體速率可依輸液量調整。

Direct IV injection should be administered slowly (approximately 3 to 5 minutes). For IV infusion, it is typically recommended to complete administration within 30 to 60 minutes, with the specific rate adjusted based on the volume of infusion fluid.
安定性
注意事項

1. 治療期間應補充足夠水分並維持充足排尿,以預防出血性膀胱炎。高劑量給藥時應併用 Mesna。2. 需定期監測血球計數(特別是白血球)與肝腎功能。3. 本品具細胞毒性,製備與給藥應遵循危險藥物處置規範。4. 應避免藥液滲漏至血管外,若發生滲漏應立即停止給藥並依規範處理。

1. Maintain adequate hydration and urine output during treatment to prevent hemorrhagic cystitis. Co-administration of Mesna is required for high-dose regimens.2. Regularly monitor blood cell counts (especially leukocytes), liver, and renal functions.3. This is a cytotoxic agent; handling and administration should follow hazardous drug protocols.4. Avoid extravasation. If extravasation occurs, stop the infusion immediately and manage according to established protocols.
藥袋資訊
臨床用途
化學治療藥
主要副作用
噁心嘔吐、毛髮稀疏、口腔炎等
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2 | 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
253
自費價
336.49
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資料庫
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