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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗癌药物->治疗卵巢癌药物
处方药:处方药
包装规格: 4毫克/4毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
HOSPIRA
生产厂家英文名:
HOSPIRA
该药品相关信息网址1:
http://www.hycamtin.com
该药品相关信息网址2:
http://www.accessdata.fda.gov/scripts/cder/onctools/summary.cfm?ID=375
原产地英文商品名:
TOPOTECAN HCL(HYCAMTIN GENERIC) 4mg/4mls/Vial
原产地英文药品名:
TOPOTECAN HCL
中文参考商品译名:
盐酸托泊替康(和美新仿制药) 4毫克/4毫升/瓶
中文参考药品译名:
盐酸托泊替康
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Carcinoma of the ovary
英文适应病症2:
cancer
临床试验期:
完成
中文适应病症参考翻译1:
卵巢癌
中文适应病症参考翻译2:
癌症
药品信息:

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(
20081220123315.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

部分中文和美新信息资料(仅供参考)

【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.

Use of Hycamtin Capsules
Hycamtin Capsules are used to treat a certain type of lung cancer called small cell lung cancer.

Hycamtin Capsules may be right for you if:

you had a complete or a partial response to your first chemotherapy
and your cancer came back at least 45 days after you finished your last dose of chemotherapy

Reasons Not to Use Hycamtin Capsules
Do not use if you have had an allergic reaction to anything in Hycamtin Capsules, if you are pregnant or think that you may be pregnant, if you are breast-feeding, or if you have low blood counts.

What should I avoid while taking Hycamtin Capsules?
Hycamtin Capsules may make you feel drowsy or sleepy both during and for several days after treatment. If you feel tired or weak, do not drive and do not use heavy tools or operate machinery.

Side Effects
Taking Hycamtin Capsules affects your bone marrow and can cause a severe decrease in your blood cell counts (bone marrow suppression) - neutrophils (a type of white blood cell important in fighting bacterial infections), red blood cells (blood cells that carry oxygen to the tissues), and platelets (important for clotting and control of bleeding).

Diarrhea may occur from taking Hycamtin Capsules, and may be serious enough that you must be treated in the hospital.

The following side effects have been reported in patients taking Hycamtin Capsules: stomach problems such as nausea (feeling sick) and vomiting; tiredness, hair loss and weakness.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. Your healthcare provider may change your dose of Hycamtin Capsules to a dose that is better for you or may stop your treatment with Hycamtin Capsules for a while. This can help reduce the side effects and may keep them from getting worse. Let your healthcare provider know if this helps or does not help your side effects.

Use of Hycamtin for Injection
Hycamtin for Injection is used for the treatment of recurrent ovarian cancer.

Hycamtin for Injection is used for the treatment of small cell lung cancer that returns at least 2 months after completion of your first treatment.

Hycamtin for Injection plus cisplatin is used for the treatment of cervical cancer, if it is widespread when first diagnosed, doesn’t go away with your first series of treatments, or comes back in a form that can’t be cured with surgery or radiation.

Reasons Not to Use Hycamtin for Injection
Do not use if you have had an allergic reaction to Hycamtin for Injection, if you are pregnant, if you are breast-feeding, or if you have low blood counts.

Side Effects
Hycamtin for Injection can often interfere with your body’s ability to make white and red blood cells. In clinical studies, 78% of patients experienced low white blood counts and 37% of patients experienced low red blood cells. Your doctor may prescribe a supportive therapy to help your body make more blood cells.

In clinical trials, side effects associated with Hycamtin for Injection when used alone included nausea (64%), vomiting (45%), diarrhea (32%), hair loss (49%), fatigue (29%), and shortness of breath (22%). Most of these side effects were mild to moderate.

In clinical trials, side effects associated with Hycamtin for Injection plus cisplatin when used to treat cervical cancer included low blood counts, pain (22%), vomiting (15%), nausea (14%), other digestive problems (14%), abnormal laboratory tests that may or may not cause symptoms (14%), and bladder/pelvic problems (12%).

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.

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 详细处方信息以本药内容附件PDF文件(20081220123315.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2011-5-3
附件:




20081220123315.pdf    

 
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