英文药名: Velcade(Bortezomib Injection) 中文药名: 万珂（硼替佐米注射液） 品牌药生产厂家: Johnson & Johnson Inc. 药品介绍 硼替佐米作为全球第一个靶向型抑制肿瘤细胞的蛋白酶体药物，已被87个国家用于多发性骨髓瘤的治疗，并于2008年6月被美国FDA批准作为多发性骨髓瘤的一线治疗用药。2008年由美国、德国、英国的35家中心联合开展的Ⅱ期临床试验显示，硼替佐米单药治疗复发或难治性MCL，起效快(中位第一次缓解时间为2个疗程)，缓解时间长（中位患者可延长13.5个月的生存期），对难治性和既往2次化疗无效的患者也有效。因此，FDA批准它作为MCL治疗的二线药物。目前我国也批准其用于MCL的单药治疗。 套细胞淋巴瘤是一组原发于淋巴结或结外部位淋巴组织的恶性肿瘤。在我国，MCL发病率占恶性肿瘤的第9位（男性）和第10位（女性），由于MCL较其他恶性肿瘤更具侵袭性，所以治疗的预后较差，是患者生存期最短的淋巴瘤亚型之一，以往没有有效的针对性药物。 【通用名】注射用硼替佐米 【商品名】万珂TM(Velcade) 【适应症】本品用于多发性骨髓瘤患者的治疗，此患者在使用本品前至少接受过两种治疗，并在最近-次治疗中病情还在进展。本品的有效性基于它的有效率。尚无临床对照试验证明其临床利益，如对存活率的改善 【用法用量】 推荐剂量：本品的推荐剂量为单次注射1.3mg／㎡，每周注射2次，连续注射2周(即在第1、4、日和11天注射)后停药10天(即从第12至第2l天)。3周为1个疗程，两次给药至少间隔72小时。在临床研究中，被确认完全有效的患者再接受另外2个周期的注射用硼替佐米治疗。建议有效的患者接受8个周期的注射用硼替佐米治疗。 剂量调整以及重新开始治疗：当发生3级非血液学的或任何4级血液学的毒性(不包括下面讨论的神经病)时，应暂停本品治疗。一旦毒性症状得到缓解，可以重新开始本品的治疗，剂量减少25%(例如：1.3mg／㎡降低到1.0mg／㎡；1.0mg／㎡降低到0.7mg／㎡)。如果患者发生与本品治疗有关的神经痛或周围感觉神经病，应按下表推荐的调整剂量进行治疗。如果患者本身患有严重的神经病，只有权衡利弊后方可使用本品。 Velcade Description This medication is a cancer chemotherapy drug used to treat certain types of tumors (e.g., multiple myeloma). It blocks certain proteins which helps to slow the growth and spread of the cancer. Velcade Directions This medication is given by injection into a vein by a healthcare professional. The dosage is based on your medical condition and response to therapy. It is important to drink plenty of fluids while you are being treated with this drug to prevent becoming dehydrated. Read the Patient Information Leaflet that comes with this drug, and consult your doctor or pharmacist if you have any questions. Velcade Cautions Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as boron, mannitol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: nerve sensation problems (e.g., peripheral neuropathy), heart disease, low blood pressure, loss of body fluids (dehydration), diabetes, liver disease, severe kidney disease, certain viral infection (herpes, shingles). To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. This drug may make you dizzy or cause vision changes. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages. Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine. Use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports to lower the chance of getting cut, bruised, or injured. Wash your hands well to prevent the spread of infections. This medication is not recommended for use during pregnancy. It may cause harm to an unborn baby. Discuss the risks and benefits with your doctor. If you become pregnant or think you may be pregnant, inform your doctor immediately. Use reliable form(s) of birth control during treatment with this drug. Consult your doctor for more details. It is not known whether this drug passes into breast milk. Breast-feeding is not recommended while using this drug due to the potential risk to the nursing infant. Consult your doctor before breast-feeding. Velcade Side Effects Dizziness, lightheadedness, nausea, vomiting, loss of appetite, diarrhea, constipation, tiredness, weakness, or blurred vision may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication can lower your body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat. Tell your doctor right away if you have any serious side effects, including: easy bruising or bleeding, tingling/numbness/pain/burning feeling of the hands or feet (peripheral neuropathy), fainting, stomach pain, black stools, coffee-ground vomit, trouble breathing, swelling or pain in the lower legs, fast/irregular heartbeat, severe headache, vision problems, mental/mood changes (e.g., rarely, thoughts of suicide), swelling of the hands/ankles/feet, change in the amount of urine, yellowing skin/eyes, dark urine. Get medical help right away if any of these rare but very serious side effects occur: chest pain, weakness on one side of the body, slurred speech, seizures. An allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects. Velcade Active Ingredients Bortezomib 【原产地英文商品名】VELCADE-3.5mg/Vial 【原产地英文药品名】BORTEZOMBI FOR INJECTION 【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！ ·万珂-3.5毫克/瓶 ·万珂-3.5毫克/瓶 【中文参考药品译名】注射用硼替佐米 【生产厂家中文参考译名】千年制药 【生产厂家英文名】Millennium ----------------------------------------------------------------- 【原产地英文商品名】Bortenat (印度VELCADE) 3.5mg/Vial 【原产地英文药品名】BORTEZOMIB FOR INJECTION 【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！ ·Bortenat (印度 万珂) 3.5毫克/瓶 ·Bortenat (印度 万珂) 2毫克/瓶 【中文参考药品译名】注射用硼替佐米 【生产厂家中文参考译名】印度Natco Pharma公司 【生产厂家英文名】Natco Pharma Ltd, India