米托蒽醌,米托蒽醌注射剂mitoxantrone(Novantrone 20mg/10ml)

药店国别:

产地国家:美国

处方药:

所属类别: 20毫克/10毫升/瓶

包装规格: 20毫克/10毫升/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Immunex Corporation

原产地英文商品名:NOVANTRONE-20mg/10ml/Vial

原产地英文药品名:MITOXANTRONE

中文参考商品译名:能灭瘤-20毫克/10毫升/瓶

中文参考药品译名:米托蒽醌

曾用名:

简介

部分中文米托蒽醌处方资料(仅供参考)

别名:诺消灵、米托蒽醌、二羟蒽二酮、二羟基蒽醌 Novantrone

英文名:Mitoxantrone,Novantrone,Dihydroxanthracenedione,DHAD,MA

作用特点:本品为人工合成的蒽环类抗肿瘤药,为仿阿霉素药品,其作用机制类似于阿霉素,可嵌入DNA,形成DNA的复合物,本品与DNA有两种结合形式:一是与碱基强有力结合而嵌入DNA,引起DNA链间和链内交叉连结,导致DNA单链及双链断裂。

另一较弱的结合是通过与螺旋链外部阴离子的静电作用,此外对RNA聚合酶也有抑制作用。本品对各细胞周期肿瘤细胞均有抑制作用,但主要作用于S后期。本品在体内广泛分布于各器官,与组织结合,分布容积为522L/m2,以后缓慢释放。

T1/2为40-120小时。有腹水等增加药物分布容积因素者T1/2可进一步延长,因此药物应减量。

本品主要靠肝脏代谢,代谢物主要由粪便排出。6-11%经肾脏排泄(其中65%为原形药)。

功能主治:用于恶性淋巴瘤、乳腺癌及各种急性白血病。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

静脉滴注,成人常用量,按体表面积14mg/m2,溶于5%葡萄糖注射液100ml内静滴30分钟,每3~4周一次。联合用药时应减少2~4mg/m2。当总剂量140~160mg/m2时,应警惕心脏毒性。

不良反应

1.中度骨髓抑制:主要是白细胞及血小板减少。

2.胃肠道反应:食欲减退、恶心呕吐等。

3.心脏毒性:本品还原力强,不易形成氧自由基及脂质体超氧化,故心脏毒性较阿霉素轻,主要表现为心肌肥大和纤维化。

注意事项

1. 对本品过敏者禁用,肝功能不全者慎用,治疗中应定期查血象。

2. 应避免药液与皮肤、眼晴接触。

3. 药液应于24小时内用完,不得和其它药物混合使用。

4. 用过阿霉素的病人,米托蒽醌累积剂量不应超过lOOmg/m2,而对未用过阿霉素的病人,限制累积剂量为16Omg/m2。

注:贮藏室温保存,勿冻结。

英文版说明

Novantrone (mitoxantrone hydrochloride)Novantrone® (mitoxantrone hydrochloride) is a synthetic anticancer agent for intravenous use. Novantrone is indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (MS). This kind of MS is characterized by gradually increasing disability and those whose neurologic status is significantly abnormal between relapses. Novantrone is not indicated for treatment of primary progressive multiple sclerosis.What are the ingredients in Novantrone?How does Novantrone work?Novantrone is a chemotherapy medication used as a disease-modifying drug (DMD) to reduce the number of MS relapses. It suppresses the body’s immune system during treatment and depletes the number of cells that attack myelin around the nerves. This therapy gives the body a chance to rest and repair.What are the possible side effects of Novantrone?Many clinical trials eva luated the safety and efficacy of Novantrone. The most common side effects experienced by those taking Novantrone include:•Nausea and vomiting•Hair thinning•Loss of menstrual periods•Bladder infections•Mouth sores•HeadacheIf you have trouble breathing, experience swelling of legs or ankles, or uneven or fast heartbeat, call 911 immediately. These problems generally happen in people who receive a lifetime dose of more than 12 doses but can also occur at lower lifetime doses.Novantrone may reduce white blood cell count, which increases the chance of getting an infection. It may also cause your platelet count to go down, which increases the chance of bleeding; this is why regular blood tests are conducted. Call the doctor if you experience fever, chills, sore throat, cough, pain with urination, urination more often, or if you notice any unusual bleeding or bruising.Things to note about NovantronePatients with MS may experience changes in cardiac function when treated with Novantrone. Before initiating therapy everyone should have a cardiac assessment including taking a history, physical examination, ECG, and quantitative LVEF (Left ventricular ejection fraction) eva luation. People with a baseline LVEF below the lower limit of normal should not be treated with Novantrone.A complete blood count including platelets, and liver function tests, should be obtained prior to each course of Novantrone, and if signs of infection develop.Novantrone and its metabolites are excreted in the bile and urine. It may cause a blue-green color to the whites of your eyes (sclera) and the urine for 24 hours after administration.Before starting Novantrone, talk with your doctor if you have:•A preexisting myelosuppression (reduction of bone marrow activity) as the result of prior drug therapy•Been treated with certain medications that can affect cardiac toxicity•Leukemia•Abnormal liver function•Planned to become pregnant, as it is generally not recommended while on Novantrone•A history of hypersensitivity or allergic reaction to mitoxantrone hydrochloride.This is not an exhaustive list of all potential side effects of Novantrone. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects when taking Novantrone, contact your doctor or healthcare provider immediately.Dosing InformatioNovantrone is supplied to medical facilities as a concentrate and must be diluted prior to injection. The recommended dosage of Novantrone is 12 mg/m2 given and should be given slowly into a freely flowing IV infusion every 3 months. Cumulative lifetime dose should not exceed 140 mg/m2.For additional details, read the full prescribing information of Novantrone.

 

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