药品信息:
部分中文和美新信息资料(仅供参考)
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(200933121312210.pdf)的“原文Priscribing Information”为准 ---------------------------------------------------------------
【药品名称】:和美新 【活性成份】:盐酸托泊替康 【临床药理】 作用机制: 拓扑异构酶I通过诱导可逆性DNA单链断裂,使DNA螺旋链松解。托泊替康与拓扑异构酶I-DNA复合物结合,从而阻碍断裂DNA单链的重新连接。托泊替康的细胞毒性作用认为是发生在DNA合成过程中,托泊替康-拓扑异构酶I-DNA形成的三元复合物与复制酶相互作用,造成双链DNA的损伤。哺乳动物细胞无法有效地修复损伤的DNA双链。 药代动力学: 给予癌症患者0.5-1.5mg/m2的托泊替康输注30分钟时,托泊替康的药代动力学特点为:半衰期2~3小时,总药时曲线下面积(AUC)与剂量基本呈正比。血浆蛋白结合率大约为35%。 代谢和排泄: PH值将影响托泊替康内酯结构的水解。内脂结构是托泊替康具有药理活性的部分。在PH值为4时,托泊替康完全以内酯结构存在;而在生理PH条件下,则以开环羟基酸的结构存在。体外研究表明,极少量的托泊替康在人肝微粒体经N-去甲基化途径代谢。 在人体,肾脏是托泊替康主要的代谢途径,约30%托泊替康经尿排泄。 【适应症】 用于治疗一线化疗或后续化疗失败的转移性卵巢癌。 【禁忌症】 和美新禁用于对托泊替康或其处方中的任何成份有过敏反应史的患者。 和美新禁用于妊娠、哺乳或有严重骨髓抑制的患者。 【警告与注意事项】 和美新需在富有化疗经验的医生指导下使用。 基础中性粒细胞数小于1500个/mm3和血小板数小于100,000个/mm3的患者禁用和美新。骨髓抑制是托泊替康剂量限制性的毒性反应。需定期监测全血细胞(包括血小板)。 【妊娠与哺乳】 和美新禁用于妊娠和哺乳期妇女。 【不良反应】 血液学: 严重中性粒细胞减少,伴发热或感染;败血症;严重的血小板减少症;中、重度贫血;严重的白细胞减少。中性粒细胞减少无累积现象。 非血液学: 恶心、呕吐、腹泻、便秘、腹痛、口炎、纳差、疲劳、乏力、脱发、高胆红素血症、呼吸困难、不适、关节痛、头痛、肌痛、疼痛。 【药物相互作用】 若需使用粒细胞集落刺激因子(G-CSF),应在疗程的第6天,即完成和美新治疗后24小时给予。 【用法用量】 首次给药: 患者首次使用和美新,其基础中性粒细胞数需>=1500个/mm3,血小板数>=100,000个/mm3,血红蛋白>=9g/dL。和美新的推荐剂量为每日一次,每次1.5mg/m2,静脉滴注30分钟,连续用药5天,每21天为一个疗程。建议至少使用4个疗程。 后续给药: 只有当患者的中性粒细胞数恢复至1000个/mm3以上,血小板数恢复至100,000个/mm3以上和血红蛋白恢复至9.0g/dL(必要时可输血)以上时,才可再次接受和美新治疗。若患者出现严重中性粒细胞减少症(中性粒细胞数低于1500个/mm3),并持续7天或更长时间;或出现严重中性粒细胞减少相关性发热或感染,或因中性粒细胞减少而推迟治疗,可按下述方案用药:下一个疗程给药量减少至1.25mg/m2;或下一疗程维持原给药剂量,并于疗程的第6天(完成和美新治疗后24小时)给予G-CSF。如果G-CSF不能很好控制中性粒细胞的减少,则需降低给药剂量。 因临床支持资料有限,不推荐儿童患者使用本品。 【肾功能不全患者】: 对于轻度肾功能不全患者(肌酐清除率在40~60ml/min范围内)无需调整剂量;中度肾功能不全患者(肌酐清除率在20~39ml/min范围内),推荐剂量调整为0.75mg/m2;对于重度肾功能不全 患者,因临床支持数据不足,尚无推荐剂量。 【肝功能不全患者】: 对于血胆红素在1.5~10mg/dL范围内的肝功能不全患者,无需调整剂量。 【老年患者】: 无需调整剂量,但肾功能不全者除外。
Hycamtin is indicated for the treatment of: metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy. small cell lung cancer sensitive disease after failure of first-line chemotherapy.
Topotecan belongs to the general group of chemotherapy drugs known as topoisomerase inhibitors.
It is used to treat advanced cervical and ovarian cancers as well and small cell lung cancer that has continued to grow after first–line therapy.
Topotecan works by stopping the growth of cancer cells by preventing the development of elements necessary for cell division.
What is the dosage and how should it be used? Topotecan is given as an intravenous injection. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 30 minutes to complete.
Tell your doctor right away if any of this medicine gets on your skin during the injection. If this does happen, the exposed skin should be rinsed thoroughly with soap and warm water.
Topotecan is usually given once daily for 5 days in a row. This treatment is then repeated every 21 days, usually for at least 4 treatments. It may take several weeks for your body to respond to the medication.
Topotecan can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Therefore, it is important that you not miss any scheduled visits to your doctor
What side effects can this medication cause? Get emergency medical help if you have any of these signs of an allergic reaction: hives difficulty breathing swelling of your face, lips, tongue, or throat
Call your doctor at once if you have any of these serious side effects:
fever, chills, body aches, or flu symptoms pale skin, easy bruising or bleeding unusual weakness white patches or sores inside your mouth or on your lips skin changes or severe irritation where the needle is placed
Other less serious side effects are more likely to occur, such as:
bruising or swelling where the medicine was injected tired feeling headache, body pain, joint or muscle pain mild skin rash loss of appetite nausea, vomiting, constipation, or stomach pain temporary hair loss
Other side effects have also been reported. Discuss with your doctor any side effect that occurs during treatment with topotecan.
What storage conditions are needed for this medicine? Store unopened vials at room temperature between 68 and 77 degrees F (20 and 25 degrees C), and away from light.
Drug diluted and ready for infusion must be used within 24 hours of mixing and can be stored at room temperature up to 77 degrees F (25 degrees C).
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(200933121312210.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- |