英文药名: Novantrone(Mitoxantrone Injection)

中文药名: 米托蒽醌注射剂, 能灭瘤

药品说明

中文通用名称: 盐酸米托蒽醌
英文通用名称: Mitoxantrone Hydrochloride
其 它 名 称: 能减瘤,能灭瘤,诺安托,二盐酸米托蒽醌,Novantron,Novantrone,Mitoxantrone Dihydrochloride,DAD,Novantrone Hydrochloride,米西宁,诺消灵,Militant,注射用盐酸米托蒽醌,盐酸米托蒽醌注射液,恒恩,诺肖林,Mitoxantrone Hydrochloride for Injection,Mitoxantrone Hydrochloride Injection
产 品 分 类: 西药\肿瘤用药\抗肿瘤药\干扰转录过程和阻止RNA合成的药物

适应症
主要用于乳腺癌、恶性淋巴瘤、急性白血病，对肺癌、黑色素瘤、软组织肉瘤、多发性骨髓瘤、肝癌、大肠癌、肾癌、前列腺癌、子宫内膜癌、睾丸肿瘤、卵巢瘤和头颈部癌也有效。

用法用量
成人
·常规剂量
·静脉滴注
1.单药治疗：一次12-14mg/m☆2☆，溶于生理盐水或5%葡萄糖注射液中(至少50ml)静脉滴注，时间不少于30分钟，每3-4周1次。或一次4-8mg/m☆2☆，一日1次，连用3-5日，间隔2-3周重复。
2.联合用药：本药一次5-10mg/m☆2☆。
儿童
·常规剂量
·静脉滴注单次剂量最高可达24mg/m☆2☆。
[国外用法用量参考]
成人
·常规剂量
·静脉给药
1.急性非淋巴细胞白血病：
(1)诱导缓解：第1-3日，本药一日12mg/m☆2☆；阿糖胞苷一日100mg/m☆2☆，第1-7日连续24小时静脉滴注。
(2)再次诱导：如果第1次诱导治疗后反应不完全，应给予再次诱导治疗，即本药一日12mg/m☆2☆，共用2日；阿糖胞苷一日100mg/m☆2☆，第1-5日连续24小时静脉滴注。
(3)巩固治疗：第1-2日，本药一日12mg/m☆2☆；阿糖胞苷一日100mg/m☆2☆，第1-5日连续24小时静脉滴注。在末次诱导治疗约6周后开始巩固治疗，在首次巩固疗程4周后进行第2次巩固治疗。
2.多发性硬化症：推荐剂量为一次12mg/m☆2☆，静脉滴注5-15分钟。每3个月重复1次。
3.前列腺癌(激素治疗无效)：合用皮质激素，本药一次12-14mg/m☆2☆，每21日1次。
4.本药的最大剂量，与粒细胞-巨噬细胞集落刺激因子(GM-CSF)合用时为37mg/m☆2☆，与紫杉醇合用时为14mg/m☆2☆。在联合治疗方案中，本药的最大耐受量(MTD)为50-75mg/m☆2☆。
·肾功能不全时剂量
肾衰竭时似乎不需要进行剂量调整。
·肝功能不全时剂量
有严重肝脏损害者，本药总清除率显著降低，建议减少剂量。
儿童
·常规剂量
·静脉给药儿童用药的安全性和疗效尚未确立，儿童耐受剂量似乎更高。
1.非淋巴细胞白血病：一次8-33mg/m☆2☆，每3-4周1次。也有用法为一次10mg/m☆2☆，一日1次，静脉滴注1小时，连用3-5日。
2.实体肿瘤：推荐用量为一次5-8mg/m☆2☆，一周1次。另一种推荐用法为一次18-20mg/m☆2☆，每3-4周1次。
3.白血病：推荐用量为一次24mg/m☆2☆，每3-4周1次。

给药说明
1.不可通过动脉内、皮下、肌内或鞘内注射给药，鞘内注射有导致截瘫的可能。
2.本药遇低温可能析出晶体，可温热待晶体溶解后使用。
3.不宜与其它药物混合使用。
4.给药时避免溶液与皮肤、粘膜或眼接触。
5.静脉注射时如药液外渗，应立即更换另一静脉通道给药。
6.用药时可大量饮水、碱化尿液以预防高尿酸血症及尿酸盐沉淀。
7.使用本药后，患者的尿液及巩膜可呈蓝色。
8.本药总累积量不宜超过140-160mg/m☆2☆。既往曾接受蒽环类药物、胸部放疗或有心脏病的患者应减少给药量(总累积量不超过100mg/m☆2☆)。使用多柔比星总累积量超过450mg/m☆2☆的患者不宜使用本药；多柔比星总累积量超过350mg/m☆2☆的患者，必须在心功能正常的情况下且在严密观察下用药。
9.当白细胞计数低于1.5×10☆9☆/L时，应停用本药。
10.药物过量的表现：据国外资料报道，有4例病人偶然注射本药140-180mg/m☆2☆，由于严重的白细胞减少伴感染而死亡。

不良反应
1.血液骨髓抑制为本药剂量限制性毒性。白细胞减少常见，血小板减少较轻，一般用药后8-15日白细胞和血小板下降至最低值，停药后22日左右可恢复。多个疗程后可导致轻度贫血。
2.胃肠道可有恶心、呕吐、食欲减退、腹泻等。
3.心血管系统本药不易形成氧自由基及脂质体超氧化，故心脏毒性较多柔比星轻。主要表现为心肌肥大和纤维化；也可有心悸、期外收缩及心电图异常；心力衰竭罕见，主要发生于既往用过多柔比星的患者。心脏毒性与本药总累积量有关，当总累积量超过140-160mg/m☆2☆时，心肌损害增加。有文献报道，本药导致心力衰竭的最低剂量为55-255mg/m☆2☆，导致左心室排血量减少的最低剂量为21-150mg/m☆2☆。此外，用药后可出现静脉炎。
4.泌尿生殖系统可引起闭经、精子缺乏及肾功能异常。偶有尿道感染等。
5.局部偶见注射局部红斑和轻度肿胀，静脉注射药液外漏时，会发生严重的局部反应。
6.其它可有脱发、皮疹、口腔炎、肝功能异常，偶有发热、呼吸困难等。

注意事项
1.禁忌症
(1)对本药过敏者。
(2)有骨髓抑制者。
(3)肝功能不全者。
(4)伴有心、肺功能不全的恶病质患者。
(5)孕妇。
(6)哺乳期妇女。
2.慎用
(1)肝、肾疾病患者。
(2)老年患者。
3.药物对妊娠的影响孕妇禁用本药。美国药品和食品管理局(FDA)对本药的妊娠安全性分级为D级。
4.药物对哺乳的影响鉴于本药可能对哺乳婴儿产生严重影响，哺乳妇女应禁用本药。
5.用药前后及用药时应当检查或监测用药过程中，应密切监测血常规、肝肾功能、心电图，必要时应行超声心动图检查。

【生产厂家】Immunex Corporation

【原产地英文商品名】NOVANTRONE-25mg/12.5ml/Vial
【原产地英文药品名】MITOXANTRONE
【中文参考商品译名】
注：以下产品不同规格和不同价格，购买时请以电话咨询为准！
·能灭瘤-20毫克/10毫升/瓶
·能灭瘤-20毫克/10毫升/瓶
·能灭瘤-25毫克/12.5毫升/瓶
·能灭瘤-25毫克/12.5毫升/瓶
·能灭瘤-30毫克/15毫升/瓶
·能灭瘤-30毫克/15毫升/瓶
·能灭瘤-2毫克/毫升, 12.5毫升/瓶
【中文参考化合物名称】米托蒽醌
【生产厂家英文名】Immunex Corporation

Brand names: Novantrone®

Mitoxantrone Hydrochloride Solution for injection

What is this medicine?

MITOXANTRONE (MYE toe ZAN trone) is a chemotherapy drug. It targets fast dividing cells, like cancer cells, and causes these cells to die. This medicine is used to treat acute nonlymphocytic leukemia (ANLL) and advanced prostate cancer. It is also used to treat certain types of multiple sclerosis.
 
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
•heart disease
•infection (especially virus infection such as chickenpox or herpes)
•liver disease
•low blood counts, like low platelets, red blood cells, white blood cells
•previous chemotherapy, especially with doxorubicin, daunorubicin, epirubicin, or idarubicin
•recent or ongoing radiation therapy
•an unusual or allergic reaction to mitoxantrone, other medicines, foods, dyes, or preservatives
•pregnant or are trying to get pregnant
•breast-feeding

How should I use this medicine?

This drug is given as an infusion into a vein. It is administered in a hospital or clinic by a specially trained health care professional. If you have pain, swelling, burning or any unusual feeling around the site of your injection, tell your health care professional right away.
 
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
 
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What may interact with this medicine?

•ciprofloxacin
•cyclosporine
•medicines to increase blood counts like filgrastim, pegfilgrastim, sargramostim
•other chemotherapy drugs like daunorubicin, doxorubicin, epirubicin, idarubicin, trastuzumab
•vaccines

Talk to your doctor or health care professional before taking any of these medicines:
•acetaminophen
•aspirin
•ibuprofen
•ketoprofen
•naproxen

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. You will need important blood work done while you are taking this medicine.

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Your urine may turn blue-green for a few days after your dose. This is normal with this medicine.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Take a pregnancy test as directed before each dose of this medicine. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
•low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
•signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
•signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
•signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness
•breathing problems
•changes in vision
•chest pain
•fast, irregular heartbeat
•mouth sores
•nausea, vomiting
•pain, swelling, redness at site where injected
•swelling of the ankles, feet, hands
•yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
•blue color in the whites of your eyes
•constipation
•diarrhea
•hair loss
•loss of appetite
•missed menstrual periods
•nail discoloration or damage
•stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Last updated: 7/1/2002