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当前位置:药品说明书与价格首页 >> 抗肿瘤药 >> 新药推荐 >> DOXIL(doxorubicin HCl盐酸多柔比星)脂质体注射剂-获准用于难治性卵巢癌

DOXIL(doxorubicin HCl盐酸多柔比星)脂质体注射剂-获准用于难治性卵巢癌

2010-11-13 11:13:44  作者:新特药房  来源:中国新特药网天津分站  浏览次数:1873  文字大小:【】【】【
简介: 【药理作用】: 盐酸阿霉素的活性成分通过插入DNA双链的碱基对与核酸结合干扰DNA和RNA的合成。在脂质体包裹的阿霉素核周围与聚乙烯甘醇衍生物结合,形成阿霉素的脂质体。这种技术称为“隐蔽技术”(ste ...

 【药理作用】: 盐酸阿霉素的活性成分通过插入DNA双链的碱基对与核酸结合干扰DNA和RNA的合成。在脂质体包裹的阿霉素核周围与聚乙烯甘醇衍生物结合,形成阿霉素的脂质体。这种技术称为“隐蔽技术”(stealth technology)。阿霉素隐蔽脂质体是在其表面与甲氧聚乙烯甘醇(MPEG)结合。这种聚合体包裹后保护了隐蔽脂质体免受单核巨噬系统的吞噬,导致在血循环时间明显增加,可能有降低阿霉素心脏毒性、增加肿瘤靶组织吸收的作用。
【药动学】: 体内半衰期大约55小时,给药后可测到低水平的Doxorubicinol(阿霉素的一种代谢物)。吸收后,本品明显分布到皮肤组织。血浆清除缓慢,剂量为20mg/m2时,平均清除率0.04lL/(h·m2)。
【适应症】: 以前用过综合治疗后发展或不能耐受这些治疗的艾滋病相关的卡波西氏肉瘤。
【用法用量】: 静脉滴注。成人剂量20mg/m2,以5%葡萄糖液250ml稀释,静脉滴注30~60分钟。稀释液在2~8℃冷冻保存下可稳定24小时,但不能与其他药物、盐水、抗生素混合。
【不良反应】: 与阿霉素的常见毒副反应相似。
1.严重的骨髓抑制为剂量限制性毒性。
2.恶心、呕吐、粘膜炎、脱发均较多见。
【相互作用】: 
【注意事项】: 1.心脏毒性与总剂量有关,推荐阿霉素的最大累积剂量为(550mg/m2)。以往用过蒽环类药物者,应减少总累积剂量。
2.治疗前、治疗期间及治疗后需作心脏监护,可监测。EKG、RNCA、超声心动图等。

美国FDA于2005年1月份给予DOXIL(doxorubicin HCl,盐酸多柔比星)脂质体注射剂以完全批准,用于经铂类化疗药治疗后病情仍进展或再发的卵巢癌病人。1999年它经加速审批程序已获准用于难治性卵巢癌。

Doxil (doxorubicin HCl), is a prescription medicine that is administered intravenously by your healthcare professional. DOXIL is used to treat patients with ovarian cancer that has progressed or recurred after platinum-based chemotherapy.

Please read Important Safety Information below, and talk to your healthcare professional to learn more about DOXIL.

Important Safety Information

Serious and possibly permanent heart-related side effects that may lead to congestive heart failure can occur in patients treated with DOXIL. Inform your doctor of any history of heart disease, radiation to your chest, or prior chemotherapy. Your doctor may monitor your heart function.
Infusion reactions may occur during administration. Be sure to tell your doctor if you have any symptoms during infusion, including: flushing, shortness of breath, facial swelling, headaches, chills, back pain, tightness in your chest or throat, dizziness, or lightheadedness. For most patients, these reactions have resolved within several hours to a day once the infusion is stopped, or for some patients with slowing of the infusion rate. However, in some cases, these reactions may be serious and sometimes life threatening, though they are rarely fatal.

DOXIL may severely reduce the number of blood cells (red blood cells, white blood cells, and platelets) in your body. Your doctor may adjust or delay your dose of DOXIL if this occurs.

Your doctor may adjust your dose of DOXIL if you have liver problems.

You should not take DOXIL if you are nursing. If you are pregnant or are planning to become pregnant, inform your doctor.

You should not take DOXIL if you are allergic to doxorubicin HCI or the components of DOXIL.

The most common side effects of DOXIL are:

Hand-Foot Syndome (HFS): Tingling or burning, redness, flaking, bothersome swelling, small blisters, or small sores on palms of hands or soles of feet
Stomatitis: Painful redness, swelling, or sores in the mouth
Fever: A fever of 100.5oF or higher
Neutropenia: Low white blood cell count
Nausea, vomiting, tiredness, weakness, rash, shortness of breath, or mild hair loss
Loss of appetite
Diarrhea
Be sure to tell your doctor immediately if you experience any of these or other symptoms.

DOXIL may make the side effects of other anticancer therapies worse when used in combination.

Following administration, DOXIL may turn urine and other bodily fluids a reddish-orange color. This is due to the color of DOXIL and will go away as the drug leaves the body.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).

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