ABRAXANE注射用紫杉醇(白蛋白结合型)—全球唯一乳腺癌靶向化疗药物 ABRAXANE注射用紫杉醇(白蛋白结合型)—全球唯一应用白蛋白纳米微粒技术生产的靶向化疗药物，适用于治疗联合化疗失败的转移性乳腺癌或辅助化疗后6个月内复发的乳腺癌。ABRAXANE注射用紫杉醇(白蛋白结合型)由美国著名的阿博利斯公司生产，2005年在美国上市，2009年进入中国，目前已在全球超过35个国家上市。 注射用紫杉醇(白蛋白结合型)的靶向治疗机理 ABRAXANE注射用紫杉醇(白蛋白结合型)是由一个个的白蛋白结合紫杉醇纳米微粒构成，这些微粒只有人体红细胞的1/100大小，外层被白蛋白包裹，内核为不溶于水的细胞毒药物。众所周知，肿瘤细胞在人体内大肆生长需要汲取足够的营养，因此肿瘤细胞会分泌一种SPARC蛋白汲取细胞间质中的蛋白质。这时，白蛋白结合紫杉醇纳米微粒通过SPARC蛋白吸附在肿瘤细胞上，并最终进入肿瘤细胞，释放出细胞毒药物，杀死肿瘤细胞，达到靶向治疗的目的。 与“饿死”肿瘤的方法相比，ABRAXANE注射用紫杉醇(白蛋白结合型)把白蛋白结合型紫杉醇优先供应给肿瘤细胞，让紫杉醇更好与之接触，导致肿瘤细胞死亡，起效更为快捷。 注射用紫杉醇(白蛋白结合型)的疗效及安全性 在对中国转移性乳腺癌患者进行的注射用紫杉醇（白蛋白结合型）与溶剂型紫杉醇随机对照II期临床试验表明：ABRAXANE注射用紫杉醇（白蛋白结合型）比溶剂型紫杉醇总有效率明显提高，该结果与对欧美地区患者所进行的全球三期临床试验的结果相一致。与溶剂型紫杉醇相比， ABRAXANE注射用紫杉醇（白蛋白结合型）使总有效率提高接近一倍，而且中位至肿瘤进展时间也比溶剂型紫杉醇延长，达到7.6 个月。与溶剂型紫杉醇相比，ABRAXANE注射用紫杉醇（白蛋白结合型）的无进展生存期也提高了26%。同时，两种治疗的最常见毒性反应相似且都是可接受的，严重不良事件的发生率基本相当，且都具有良好的耐受性。 美国休斯敦米歇尔（Michael）等进行的一项Ⅱ期临床试验显示，注射用紫杉醇（白蛋白结合型）治疗铂敏感的复发性卵巢癌、腹膜癌或输卵管癌有效且患者耐受性良好。该研究共纳入47例组织学或细胞学确诊的卵巢、输卵管或腹膜上皮癌患者，在21天治疗周期中的第1天给予30分钟静脉nab-紫杉醇260 mg/m2治疗，共6个周期或直到疾病进展。 结果显示，在44例可评估者中，客观有效率（ORR）为64%，中位至缓解时间为1.3个月，中位PFS期为8.5个月，最常见的3至4级治疗相关毒性反应为中性粒细胞减少（24%）和神经病变（9%）。 注射用紫杉醇(白蛋白结合型)使用更方便 由于传统的紫杉醇类药物在使用中需要聚乙烯蓖麻油作为溶剂才能进行注射，而为了预防溶剂带来的过敏反应，患者需要在化疗前进行预防用药，使用抗阻胺及地塞米松等药物，而最新上市的注射用紫杉醇(白蛋白结合型)无需使用溶剂，因此输注时间更短，与溶剂型紫杉醇的3个小时相比，该药物仅需30分钟输注，并且给药前无需抗过敏预防用药，即可降低与溶剂相关的过敏反应的潜在风险。因此，注射用紫杉醇(白蛋白结合型)极大方便了患者的使用。 注射用紫杉醇(白蛋白结合型)说明书简明资料 【药品名称】 通用名称：注射用紫杉醇(白蛋白结合型) 英文名称：Paclitaxel For Injection（Albumin Bound） 汉语拼音：Zhesheyong Zishanchun (Baidanbaijiehexing) 【成份】 每瓶含紫杉醇100mg及人血白蛋白约900mg。 【性状】 本品为无色或淡黄色澄明粘稠液体。 【适应症】 适用于治疗联合化疗失败的转移性乳腺癌或辅助化疗后6个月内复发的乳腺癌。除非有临床禁忌症，既往化疗中应包括一种蒽环类抗癌药。 【用法用量】 分散溶解后每毫升悬浮液含5美国紫杉醇。对联合化疗失败的转移性乳腺癌或辅助化疗后复发的乳腺癌患者，建议使用剂量260mg/m2，静脉滴注30分钟，每3周给药一次。 本品给药前不需给予患者抗过敏药预处理。 【不良反应】 肝酶和胆红素升高。红细胞压积和红细胞计数降低，中性粒细胞减少（包括发热性中性粒细胞减少），白细胞减少，血小板减少和淋巴细胞减少，外周神经病变包括感觉神经和运动神经病变，神经病变，呼吸困难，咳嗽，恶心，呕吐腹泻，脱发，皮疹，瘙痒，关节痛，肌肉痛，感染，过敏反应，低血压，黏膜炎，潮红，乏力，胸痛，肺炎，皮疹。其它不良反应参见药品说明书。 【规格】100mg 【贮藏】含药物的药瓶放在原装盒中，室温（20～25℃）条件下避光保存。 【包装】玻璃瓶装，每盒一瓶。 Abraxane Generic Name: paclitaxel protein-bound (PAK li TAX el PRO teen-bound) Brand Names: Abraxane What is Abraxane? Abraxane (paclitaxel) is a cancer medication that interferes with the growth and spread of cancer cells in the body. Abraxane is used in the treatment of breast cancer. It is usually given after other cancer medicines have been tried without successful treatment. Abraxane may also be used for purposes not listed in this medication guide. Important information about Abraxane Do not use Abraxane if you are pregnant. It could harm the unborn baby. Use birth control to prevent pregnancy while you are receiving Abraxane, whether you are a man or a woman. Abraxane use by either parent may cause birth defects. You should not use Abraxane if you are allergic to paclitaxel, or if you have a low white blood cell count. Before you receive Abraxane, tell your doctor if you have kidney disease, liver disease, heart disease, or bone marrow suppression. To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor. Call your doctor at once if you have a serious side effect while using Abraxane such as fever, chills, flu symptoms, mouth sores, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, swelling or rapid weight gain, chest pain, sudden cough, rapid heart rate, or trouble breathing. Before receiving Abraxane You should not use Abraxane if you are allergic to it, or if you have a low white blood cell count. To make sure you can safely receive Abraxane, tell your doctor if you have any of these other conditions: kidney disease; liver disease; heart disease; or bone marrow suppression. FDA pregnancy category D. Do not use Abraxane if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Use birth control to prevent pregnancy while you are receiving Abraxane, whether you are a man or a woman. Abraxane use by either parent may cause birth defects. It is not known whether paclitaxel protein-bound passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are receiving Abraxane. How is Abraxane given? Abraxane is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. The injection must be given slowly, and the IV infusion can take at least 30 minutes to complete. Abraxane is usually given once every 3 weeks. Follow your doctor's dosing instructions very carefully. Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when Abraxane is injected. To make sure Abraxane is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor. What happens if I miss a dose? Call your doctor for instructions if you miss an appointment for your Abraxane injection. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include some of the serious side effects listed in this medication guide. What should I avoid while using Abraxane? Abraxane can be harmful if it gets in your eyes, mouth, or nose, or on your skin. If skin contact occurs, wash the area with soap and water or rinse the eyes thoroughly with plain water. Abraxane side effects Get emergency medical help if you have any of these signs of an allergic reaction to Abraxane: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as: fever, chills, body aches, flu symptoms, sores in your mouth and throat; easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; feeling like you might pass out; swelling, rapid weight gain; or chest pain, sudden cough, wheezing, trouble breathing, fast heart rate. Less serious Abraxane side effects may include: numbness or tingly feeling; muscle or joint pain; nausea, vomiting; diarrhea; or hair loss. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. What other drugs will affect Abraxane? Tell your doctor about all other medicines you use, especially: bosentan (Tracleer); conivaptan (Vaprisol); imatinib (Gleevec); isoniazid (for treating tuberculosis); montelukast (Singulair) or zafirlukast (Accolate); rifampin (Rifater, Rifadin, Rifamate); selegiline (Eldepryl, Emsam, Zelapar); an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek); an antidepressant such as nefazodone or fluoxetine (Prozac); antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend); a blood thinner such as warfarin (Coumadin); cancer medication such as paclitaxel (Taxol) or tamoxifen (Soltamox); heart or blood pressure medications such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), diltiazem (Cartia, Cardizem), felodipine (Plendil), losartan (Hyzaar, Cozaar), nifedipine (Nifedical, Procardia), torsemide (Demadex), verapamil (Calan, Covera, Isoptin, Verelan), and others; HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir); seizure medications such as fosphenytoin (Cerebyx), or phenytoin (Dilantin); oral diabetes medication such as glimepiride (Amaryl), glipizide (Glucotrol), nateglinide (Starlix), pioglitazone (Actos, Actoplus Met), repaglinide (Prandin), rosiglitazone (Avandia, Avandamet), or tolbutamide (Orinase); or sulfa drugs (Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others). This list is not complete and other drugs may interact with Abraxane. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.