部分中文苯达莫司汀处方资料（仅供参考）                Treanda为美国Cephalon公司研制的新型抗肿瘤药物，化学名“苯达莫司汀”，属于烷化剂的一种。其抗肿瘤作用的发挥机制是破坏癌症细胞的DNA，从而导致细胞凋亡。 慢性淋巴细胞性白血病（CLL）是危害人类健康的恶性肿瘤之一，表现为由于淋巴细胞肿瘤样增殖，其特点为成熟形态的淋巴细胞在体内积聚使血液和骨髓中淋巴细胞增多，淋巴结、肝、脾肿大，最后累及淋巴系统以外的其他组织，CLL细胞呈单克隆性增殖，95％以上的慢淋为B细胞型，3－5％为T细胞型。 CLL在我国发生率较低，仅占慢性白血病的10％，日本和印度与我国相似，而欧美发病率很高，占慢性白血病的50％或更多，患者多为老年人，50岁以上占90％，男女之比为2∶1。 通过以上信息，我们也发现，尽管CLL非常罕见，但美国却是CLL相对高发的地区之一，Cephalon公司才致力于研究Treanda来攻克这一顽症。根据该公司提交的报告，美国每年大约新增15,000位CLL患者，严重影响了他们的健康。 Cephalon公司公布的一个试验数据标明，在有301位CLL患者参加的阳性对照试验中，Treanda组患者的有效率及存活期都优于已上市的化疗药物。 因此，美国FDA批准了该药的上市，并且，对了表彰Cephalon公司为攻克CLL这种罕见疾病所做出的贡献，FDA给了该公司一段时间的独占期。健康新闻3月20日报道：治疗慢性淋巴细胞性白血病（CLL）的新药Treanda通过了美国FDA的审核，即将在4月份上市。 英文名：Bendamustine 品种概述 盐酸苯达莫司汀最早于19世纪60年代初期由Ozegowski和其同事在德国耶拿的微生物试验协会研制。合成的目的是使一种烷基化氮芥（一种非功能烷化剂）连接一个嘌呤和氨基酸。新合成的化合物与苯丁酸氮芥相比主要的优点是它的水溶性。 Angeretal.公开了苯达莫司汀对浆细胞瘤病人成功应用的最初临床结果。苯达莫司汀从1971年到1992年以Cytostasan的商品名由耶拿制药公司生产。从1993年后，这种细胞生长抑制剂被ribosepharm GmbH公司以Ribomustine的商品名上市销售。 最近，美国FDA于2008年3月21日批准Cephalon公司的盐酸苯达莫司汀（bendamustine，Treanda）用于慢性淋巴细胞性白血病（CLL）。CLL是1种恶性的淋巴细胞克隆性增殖性疾病，多见于老年人，平均发病年龄70岁，且男性多于女性。据美国癌症学会预计，2008年美国将有15000例CLL新发病例。分析师预计本品年销售峰值在3～5亿美元。 此外，本品另一适应证－非霍奇金淋巴瘤目前正等待FDA批准。 药理特点 盐酸苯达莫司汀(Bendamustine Hydrochloride)是一种双功能基烷化剂，具有抗肿瘤和杀细胞作用。本品的抗肿瘤和杀细胞作用主要归功于DNA单链和双联通过烷化作用交联，这打乱了DNA的功能和DNA的合成，也会使DNA和蛋白之间，以及蛋白和蛋白之间产生交联，从而发挥抗肿瘤作用。本品作为单用或联合化疗,对何杰金氏淋巴瘤和非何杰金氏淋巴瘤的治疗反应率分别为61%～97%和41%～48%。 临床应用 本项目主要应用于单独或与其它抗肿瘤药物联合用药来治疗下列恶性肿瘤：何杰金病；非何杰金淋巴瘤；浆细胞瘤（多发性骨髓瘤）；慢性淋巴细胞白血病（CLL）；乳腺癌。 本品用于何杰金病、非何杰金淋巴瘤、多发性骨髓瘤、CLL和乳腺癌。其剂量血癌为50～60mg/m2/d,3～5天或每3～4周为100～120 mg/m2 ；实体瘤每4 周为120～150 mg/m2 ,每日1次,30～60 min 静脉滴注。 盐酸苯达莫司汀作为单用或联合化疗,对何杰金病和非何杰金淋巴瘤的治疗反应率分别为61%～97%和41%～48%。对多发性骨髓瘤病人,苯达莫司汀/泼尼松治疗的完全反应率较高(32 %) ,美法仑/泼尼松疗法反应更持久。在环磷酰胺、长春新碱、泼尼松治疗方案中,苯达莫司汀取代环磷酰胺,对发展中低度毒性非何杰金淋巴瘤有相似的反应率。在环磷酰胺、甲氨蝶呤、氟尿嘧啶治疗方案中,苯达莫司汀取代环磷酰胺,使转移性乳腺癌病人的缓解期从6.2 个月延长至15.2个月。 盐酸苯达莫司汀( bendamustine) 是双功能基烷化剂,体外对人卵巢癌和乳腺癌有细胞毒性,体外与环磷酰胺、美法仑(melphalan) 、卡莫司汀(carmustine)和顺铂有部分交叉耐受。对乳腺癌细胞系MCF7抑制细胞生长的IC50为138μmol/L,对顺铂抗药性卵巢癌细胞系A27802CP2的IC50为157μmol/L ,对多柔比星抗药性乳腺癌细胞系MCF7AD 的IC50为187μmol/L。在等毒性浓度(IC50s)下,苯达莫司汀比美法仑、环磷酰胺或卡莫司汀引起更多的DNA双螺旋断裂,比卡莫司汀或环磷酰胺作用更持久。体外引起浓度依赖性的B2慢性淋巴细胞白血病(B2CLL)细胞凋亡,与氟达拉滨(fludarabine) 合用,在48 h 内凋亡率高1.4倍。在Ⅰ期临床试验中,苯达莫司汀60～80 mg/m2每周1次,至8周,对顽固性实体瘤病人引起持久性的全淋巴细胞减少,主要为B细胞毒性。4周后,外周血B细胞、自然杀伤细胞和T 细胞分别下降90%,70%和60%以上。 TREANDA is available in 100-mg and 25-mg vials Treanda Generic Name: bendamustine (BEN da MUS teen) Brand Names: Treanda ------------------------------------------------------------------- TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established. TREANDA is indicated for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen. Important Safety Information Serious adverse reactions, including myelosuppression, infections, infusion reactions and anaphylaxis, tumor lysis syndrome, skin reactions including SJS/TEN, other malignancies, and extravasation, have been associated with TREANDA. Some reactions, such as myelosuppression, infections, and SJS/TEN (when TREANDA was administered concomitantly with allopurinol and other medications known to cause SJS/TEN), have been fatal. Patients should be monitored closely for these reactions and treated promptly if any occur Adverse reactions may require interventions such as decreasing the dose of TREANDA, or withholding or delaying treatment TREANDA is contraindicated in patients with a known hypersensitivity to bendamustine or mannitol. Women should be advised to avoid becoming pregnant while using TREANDA The most common non-hematologic adverse reactions associated with TREANDA (frequency ≥15%) were pyrexia, nausea, and vomiting. The most common hematologic abnormalities associated with TREANDA (frequency ≥15%) were anemia, thrombocytopenia, neutropenia, lymphopenia, and leukopenia -------------------------------------------------------------------------------------------- Treanda Generic Name: Bendamustine (BEN-da-MUS-teen)Brand Name: Treanda Treanda is used for: Treating chronic lymphocytic leukemia (CLL). It is also used to treat a certain type of non-Hodgkin lymphoma (NHL) in certain patients. It may also be used for other conditions as determined by your doctor. Treanda is an alkylating agent. It works by blocking the growth of cancer cells. Do NOT use Treanda if: you are allergic to any ingredient in Treanda (including mannitol) you have moderate to severe liver problems you have severe kidney problems Contact your doctor or health care provider right away if any of these apply to you. Before using Treanda : Some medical conditions may interact with Treanda . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you: if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances (eg, mannitol) if you have an infection, liver or kidney problems, other types of cancer, or bone marrow depression if you smoke or have a history of tobacco use Some MEDICINES MAY INTERACT with Treanda . Tell your health care provider if you are taking any other medicines, especially any of the following: Ciprofloxacin or fluvoxamine because they may increase the risk of Treanda 's side effects Omeprazole because it may decrease Treanda 's effectiveness This may not be a complete list of all interactions that may occur. Ask your health care provider if Treanda may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine. How to use Treanda : Use Treanda as directed by your doctor. Check the label on the medicine for exact dosing instructions. Treanda is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Treanda at home, a health care provider will teach you how to use it. Be sure you understand how to use Treanda . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Treanda if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. If Treanda accidentally spills on your skin, wash it off right away with soap and water. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Treanda , contact your doctor right away. Ask your health care provider any questions you may have about how to use Treanda . Important safety information: Treanda may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Treanda with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Treanda may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools. If vomiting or diarrhea occurs, you will need to take care not tobecomedehydrated. Contact your doctor for instructions. If you may become pregnant, you must use an effective form of birth control while you receive Treanda and for 3 months after you stop it. If you have questions about effective birth control, talk with your doctor. Men who take Treanda should always use a condom when having sex with a woman who may become pregnant. Do this for as long as you take Treanda and for 3 months after you stop taking it. Treanda may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills. Check with your doctor before having immunizations (vaccinations) while you are using Treanda . Tell your doctor or dentist that you take Treanda before you receive any medical or dental care, emergency care, or surgery. Use of Treanda may increase your risk of developing another cancer. Discuss any questions or concerns with your doctor. Lab tests, including blood chemistry, uric acid levels, complete blood cell counts, or liver or kidney function, may be performed while you use Treanda . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Treanda should be used with extreme caution in CHILDREN;safetyandeffectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Treanda may cause harm to the fetus. Avoid becoming pregnant while you are using Treanda and for 3 months after you stop Treanda . If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Treanda while you are pregnant. It is not known if Treanda is found in breast milk. Do not breast-feed while taking Treanda . Possible side effects of Treanda : All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome: Constipation; cough; diarrhea; drowsiness; dry mouth; headache; loss of appetite; mild fever; mild itching, pain, redness, or swelling at the injection site; mouth sores; nausea; stomach pain; tiredness; vomiting; weakness. Seek medical attention right away if any of these SEVERE side effects occur: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; decreased urination; fast or irregular heartbeat; fever, chills, or persistent sore throat; persistent or severe cough; redness, swelling, peeling, or blistering of the skin; severe or persistent tiredness or weakness; shortness of breath; unusual bruising or bleeding; unusual swelling; unusual weight loss. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch. If OVERDOSE is suspected: Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include irregular heartbeat; loss of coordination; seizures; severe drowsiness; tremor; trouble breathing. Proper storage of Treanda : Treanda is usually handled and stored by a health care provider. If you are using Treanda at home, store Treanda as directed by your pharmacist or health care provider. Keep Treanda out of the reach of children and away from pets. General information: If you have any questions about Treanda , please talk with your doctor, pharmacist, or other health care provider. Treanda is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. This information is a summary only. It does not contain all information about Treanda . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider. ------------------------------------------------------------------- 原产地英文商品名: TREANDA 100mg/20ml/vial 原产地英文药品名: BENDAMUSTINE HCL 中文参考商品译名: TREANDA 100毫克/20毫升/瓶 中文参考药品译名: 盐酸苯达莫司汀 生产厂家中文参考译名: CEPHALON 生产厂家英文名: CEPHALON ------------------------------------------------------------------- 原产地英文商品名: TREANDA 25ml/vial 原产地英文药品名: BENDAMUSTINE HCL 中文参考商品译名: TREANDA 25毫升/瓶 中文参考药品译名: 盐酸苯达莫司汀 生产厂家中文参考译名: CEPHALON 生产厂家英文名: CEPHALON