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 详细处方信息以本药内容附件PDF文件（201222618184120.pdf）的“原文Priscribing Information”为准
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部分中文Halaven处方资料（仅供参考）

Halaven(甲磺酸艾日布林)新型化疗药获准用于晚期乳腺癌
2010年11月15日，美国食品药品管理局(FDA)宣布，Halaven(甲磺酸艾日布林)已获准用于治疗曾接受至少2种以前的晚期化疗方案治疗的转移性乳腺癌患者。

Halaven是一种从黑色软海绵(Halichondria okadai)中提取的一种有化疗活性化合物的合成制剂。该注射药是一种微管抑制剂，能抑制癌细胞生长。在接受Halaven治疗之前，患者应先接受以前的以蒽环类为基础和以紫杉烷为基础的化疗方案治疗早期或晚期乳腺癌。

Halaven的安全性与疗效在一项涉及762例转移性乳腺癌女性患者的单项研究中得到证实，这些患者曾采用至少2种以前的化疗方案治疗晚期疾病，她们被随机分配至接受Halaven治疗组或接受由其肿瘤医生选择的不同种单药治疗组。

该研究旨在测定总生存时间。Halaven治疗组的中位总生存时间为13.1个月，而单药治疗组为10.6个月。使用Halaven最常见的不良反应包括中性粒细胞减少症、贫血、白细胞减少症、脱发、疲乏、恶心、无力、便秘和周围神经病变。

Who is Halaven for?
Halaven is for patients with breast cancer who have received at least two other types of anticancer medicines for their breast cancer once it has spread. Previous therapy should have included an anthracycline and a taxane for either early or advanced breast cancer.

What important safety information do I need to know about Halaven?
Decreased White Blood Cells (Neutropenia)
Your doctor should do a blood test to monitor your blood cells before you receive each dose of Halaven, and should monitor you more often if you develop lower white blood cells
If you develop severe neutropenia lasting longer than 7 days or neutropenia with a fever, your next dose of Halaven should be delayed and reduced. Severe neutropenia occurred in 57% (287/503) of patients who received Halaven and lasted more than 1 week in 12% (62/503) of patients
Neutropenia with a fever occurred in 5% (23/503) of patients; 2 patients died from complications of neutropenia with a fever
Neutropenia with a fever can result in serious infections that could lead to hospitalization or death. Call your health care provider immediately if you have any of the following symptoms: fever (temperature above 100.5°F), chills, coughing, and burning or pain when you urinate

Nerve Disorders (Peripheral Neuropathy)
Halaven can cause numbness, tingling, or burning in your hands and feet (peripheral neuropathy). You should be monitored closely for signs of neuropathy. If you develop severe neuropathy, treatment with Halaven should be delayed until the neuropathy improves and the next dose of Halaven should be reduced
Severe peripheral neuropathy occurred in 8% (42/503) of patients who received Halaven. Neuropathy lasting more than 1 year occurred in 5% of patients. Twenty-two percent (109/503) of patients developed a new or worsening neuropathy that had not recovered after an average of 269 days
Peripheral neuropathy was the most common side effect that caused patients to stop taking Halaven

Pregnancy and Nursing
Halaven may harm your unborn baby. Avoid becoming pregnant while you are receiving Halaven. Tell your health care provider right away if you become pregnant or think you are pregnant while you are receiving Halaven
You and your health care provider should decide if you will take Halaven or breast-feed. You should not do both

Heartbeat Changes
Halaven can cause changes in your heartbeat (called QTc prolongation). This can cause irregular heartbeats that may lead to death
Your health care provider will decide if you need heart monitoring (electrocardiogram or ECG) or blood tests during your treatment with Halaven to watch for this problem

Liver and Kidney Problems
In patients with mild or moderate liver problems, and/or moderate kidney problems, a lower starting dose of Halaven is recommended

Most Common Side Effects
The most common side effects reported in ≥25% of patients receiving Halaven were low white blood cells (82%); low red blood cells (58%); weakness/tiredness (54%); hair loss (45%); numbness, tingling, or burning in the hands and feet (35%); nausea (35%); and constipation (25%)
The most common serious side effects reported in patients receiving Halaven were neutropenia with or without a fever (4% and 2%, respectively)

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 详细处方信息以本药内容附件PDF文件（201222618184120.pdf）的“原文Priscribing Information”为准
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