多柔比星脂质体(Doxil)是一种阿霉素脂质体,对许多实体瘤具有显著活性,美国已批准用于Kaposi′s肉瘤和卵巢癌临床治疗。 DOXIL®（盐酸多柔比星脂质体doxorubicin hydrochloride liposome）注射液为静脉使用 美国首次批准：1995 警告： 心肌病和输注相关反应的见完整的黑框警告完整的处方信息。 心肌损伤可能会导致充血性心脏衰竭和多柔比星盐酸的总累积剂量接近550毫克/米2，可能会发生。心肌病的风险可能在较低的累积剂量与纵隔照射增加。 急性输注相关反应发生的实体瘤患者11％。严重，威胁生命的，和致死性输液反应已有报道。药物/应急设备治疗这些反应，应可立即使用。 目前的主要变化 黑框警告 01/2015 剂量和给药方法 01/2015 禁忌  01/2015 警告和注意事项 01/2015 适应症和用法 DOXIL是蒽环拓扑异构酶II抑制剂表示为： 卵巢癌 铂类化疗失败后。 艾滋病相关的卡波西肉瘤。 前全身化疗或不能耐受这样的治疗失败后。 多发性骨髓瘤。 在谁以前没有收到硼替佐米，并已收到至少一个前治疗的患者硼替佐米组合。 用法用量 管理DOXIL以1mg的初始速率/分钟，以尽量减少输注反应的风险。如果没有发生输液反应有关，增加输液速度完全管理超过1小时。不给药作为推注或原液。 卵巢癌：50毫克/平方米IV，每4周。 艾滋病相关的卡波西肉瘤：20毫克/平方米IV，每3周。 多发性骨髓瘤：在第4天30毫克/平方米IV以下硼替佐米。 剂型和规格 阿霉素盐酸盐（HCl）的脂质体注射剂：独使用小瓶：20毫克/10毫升和50毫克/毫升25。 禁忌 超敏反应对阿霉素盐酸或DOXIL的部件。 警告和注意事项 可能会出现手足综合征。调整剂量或停药可能需要。 胚胎 - 胎仔毒性：可引起胎儿危害。提醒潜在风险胎儿。使用有效的避孕。 不良反应 最常见的不良反应（>20％）是虚弱，疲劳，发烧，厌食，恶心，呕吐，口炎，腹泻，便秘，手足综合征，皮疹，中性粒细胞减少，血小板减少，贫血。 特殊人群中使用 哺乳期：哺乳请停止。 IMPORTANT SAFETY INFORMATION INDICATIONS DOXIL® (doxorubicin HCl liposome injection) is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. DOXIL® in combination with bortezomib is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. DOXIL® is administered intravenously by your healthcare professional. 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 anticancer therapy. Your doctor will monitor your heart function. Infusion-related reactions may also 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, chest pain, back pain, tightness in your chest or throat, dizziness, or lightheadedness. In some cases, these reactions may be serious and sometimes life-threatening and may be fatal. You should not take DOXIL® if you have a prior history of allergic reactions to doxorubicin or other ingredients found in the formulation. Please inform your doctor about your history of allergic reactions to medications or other substances. DOXIL® may severely reduce the number of blood cells (red blood cells, white blood cells, and cells that prevent bleeding called platelets) in your body that may potentially increase risk of infections, anemia, and bleeding. Speak to your doctor if you notice any changes in your health such as a new onset fever or symptoms of infection. Your doctor will monitor your blood laboratory results. Hand-Foot Syndrome may occur while taking DOXIL®. This may lead to tingling or burning, redness, flaking, bothersome swelling, small blisters, or small sores on palms of hands or soles of feet. In certain cases, this reaction can be more severe leading to serious infections, interfering with walking and other daily activities. Cases of oral cancer have been reported in people who had taken DOXIL® for more than one year. The oral cancer was diagnosed during treatment and up to 6 years after the last dose. Your doctor will examine you at regular times for the signs and symptoms of oral cancer. If you are pregnant, planning to become pregnant, or nursing, inform your doctor. DOXIL® can cause fetal harm. Nursing should be discontinued during treatment with DOXIL®. Females and males of reproductive potential should use effective contraception during and for 6 months following treatment with DOXIL®. DOXIL® may cause temporary or permanent infertility. The most common side effects reported in at least 20% of patients treated with DOXIL® during clinical studies were: weakness, tiredness, fever, nausea, stomatitis (painful redness, swelling, or sores in the mouth), vomiting, diarrhea, constipation, loss of appetite, hand-foot syndrome, rash, low white blood cell count, low platelet count, and anemia. Tell your doctor if you experience these or other side effects. In the treatment of multiple myeloma, nerve damage called peripheral neuropathy, which may lead to pain, numbness, burning sensation, tingling, and more serious symptoms, was reported in >40% of patients. Be sure to tell your doctor immediately if you experience any of these or other symptoms. 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. Your doctor may prescribe antinausea medications before or during your DOXIL® treatment. Talk to your doctor if you have a history of heart disease or liver disease, or have received prior radiation therapy and/​or anticancer therapy. Please see full Product Information for more details. Please talk to your doctor or nurse if you have any additional questions regarding DOXIL®. For more information about DOXIL® therapy, please visit www.DOXIL.com. ------------------------------------------------------------- 产地国家：美国 原产地英文商品名: DOXIL 2mg/ml 10mls/vial 原产地英文药品名: DOXORUBICIN HCL LIPOSOMAL 中文参考商品译名: DOXIL 2毫克/毫升 10毫升/瓶 中文参考药品译名: 盐酸阿霉素脂质体 生产厂家中文参考译名: Janssen Biotech, Inc. 生产厂家英文名: Janssen Biotech, Inc. ------------------------------------------------------------- 产地国家：美国 原产地英文商品名: DOXIL 2mg/ml 10mls/vial 原产地英文药品名: DOXORUBICIN HCL LIPOSOMAL 中文参考商品译名: DOXIL 2毫克/毫升 10毫升/瓶 中文参考药品译名: 盐酸阿霉素脂质体 生产厂家中文参考译名: 奥多生物制药 生产厂家英文名: ORTHO BIOTECH 该药品相关信息网址1: http://www.doxil.com