日前，美国食品和药品管理局（FDA）批准Yervoyipilimumab用于治疗恶性黑素瘤晚期转移性患者，该病目前被认为是最危险的皮肤癌，FDA宣称应用此药治疗可延长黑素瘤患者的寿命。 Yervoy为单克隆抗体静脉注射药物。该药可以阻断细胞毒辣素T淋巴细胞抗原或CTLA-4的分子（CTLA-4会降低或阻断人体免疫系统，影响其抵御癌细胞的能力）。Yervoy作用机制是通过允许人体免疫系统识别、定向、攻击黑素瘤肿瘤内细胞来发挥作用。已完成的一项纳入了676例黑素瘤患者的单中心临床试验证实了Yervoy的安全性和有效性。 YERVOYTM（ipilimumab）注射，静脉滴注 最初美国批准：2011 适应症 YERVOY是人类的细胞毒性T淋巴细胞抗原4（CTLA-4）阻断抗体表明为不可切除或转移性黑色素瘤的治疗。   剂量和用法 YERVOY 3毫克/千克超过90分钟，每3周静脉注射管理，共有4个剂量。 永久停止对严重不良反应。 剂型和优势 50 mg/10毫升（5毫克/毫升） 200 mg/40毫升（5毫克/毫升）   禁忌 没有。   注意事项： 免疫介导的不良反应：永久停止剧烈反应。隐瞒温和的免疫介导的不良反应的剂量，直到返回到基线，​​改善轻微的严重性，或完整的决议，和病人接受小于7.5毫克强的松或相当于每天。管理严重，持久，或经常性的免疫介导的反应，全身大剂量的皮质类固醇。 免疫介导的肝炎：评估每个剂量YERVOY前的肝功能化验。 免疫介导的内分泌：监测甲状腺功能试验和临床化学各剂量之前。每次访视评估，内分泌失调的症状和体征。研究所激素替代疗法的需要。   不良反应 最常见的不良反应（≥5％），乏力，腹泻，皮肤瘙痒，皮疹，和结肠炎。 报告疑似不良反应，联系施贵宝公司在1-800-721-5072或FDA在1-800-FDA-1088或www.fda.gov / medwatch。 在特殊人群中使用 妊娠：根据动物实验数据，YERVOY可能会对胎儿造成伤害。 哺乳母亲：终止哺乳或，停止YERVOY。 日期：03/2011 美国FDA批准ipilimumab用于治疗晚期玄色素瘤 美国FDA于2011年3月25日批准ipilimumab（商标名称为Yervoy）用于治疗晚期玄色素瘤。 玄色素瘤是最危险的一种皮肤癌，也是最主要的一种致死性皮肤病。据美国国立癌症研究院统计，2010年全美国总共诊断出例玄色素瘤新病例，全年有8700人死于该病。 据FDA相关主管官员先容，晚期玄色素瘤具有毁灭性，治疗药物极少，而且无一能有效延长患者寿命。Yervoy是FDA批准的第一种确实能延长患者寿命的治疗晚期玄色素瘤药物。 Yervoy是一种单克隆抗体，能有效阻滞一种叫做细胞毒性T细胞抗原-4（CTLA-4）的分子。CTLA-4会影响人体的免疫系统，削弱其杀死癌细胞的能力。Yervoy的作用机制可能是帮助人体免疫系统识别、瞄准并攻击玄色素瘤癌细胞。其给药方式是静脉注射。 Yervoy的安全性与有效性经过一项单一的国际性研究得到验证。该项研究有676名玄色素瘤患者参加，所有的受试对象都对常用治疗药物无反应，并且癌细胞已经扩散或者无法通过手术予以切除。 该研究的主要目的是确定患者的生存期限，即开始服药至患者死亡的时间。受试患者被随机分成三组：第一组服用Yervoy加一种叫做gp100的试验性癌症疫苗；第二组单独服用Yervoy；第三组单独服用gp100。 试验结果是：同时服用Yervoy和gp100的患者及单独服用Yervoy的患者均匀可生存大约10个月，而且单独服用gp100的串者均匀生存期限只有6.5个月。 Yervoy的常见副作用（主要因自身免疫反应而引致）包括：疲乏、腹泻、皮肤红疹、内分泌不足、肠道炎症（结肠炎）等。12.9%的受试患者会发生致命性的自身免疫反应。一旦发生严重副作用，则立即停止服用Yervoy并使用皮质类固醇进行治疗，但此措施并不是对所有病人有效。由于Yervoy具有上述非同平常且极严重的副作用，FDA要求医护职员及患者都应对此严重风险有足够的熟悉。 Yervoy: monoclonal antibody for the treatment of skin cancer 30 August 2011, 9:29am BMS has launched Yervoy (ipilimumab) in the UK for advanced unresectable or metastatic melanoma following prior therapy. PHARMACOLOGY Ipilimumab is a fully human monoclonal antibody that indirectly enhances T-cell mediated responses by blocking the inhibitory signal of cytotoxic T-lymphocyte antigen-4 (CTLA-4). This results in T-cell activation, proliferation and lymphocyte infiltration into tumours, leading to tumour cell death.1 CLINICAL STUDIES A randomised, double-blind, multicentre phase III study (n=676) to establish the efficacy of ipilimumab was conducted using an experimental melanoma peptide vaccine (gp100) as control. Patients with unresectable stage III/IV melanoma were randomised to receive ipilimumab, ipilimumab plus vaccine or vaccine alone (3:1:1). Ipilimumab, alone or in combination with the peptide, produced a significantly longer median overall survival of approximately 10 months compared with 6.4 months for patients receiving gp100 monotherapy (p<0.001). There was no significant difference in overall survival between the two ipilimumab groups.2 The most common adverse events were immune-related reactions, which occurred in approximately 60% of the treatment groups and 32% of the control group. Although ipilimumab-related adverse events can be severe, long-lasting or both, most are reversible with treatment. A total of 14 deaths related to study drugs were reported (with 7 from immune-related adverse events).2 Medication name Generic name: Ipilimumab - Injection Brand name(s): Yervoy Warning This medication can cause serious (sometimes fatal) side effects in many parts of the body. These effects can occur during treatment with ipilimumab, but can also occur months after the last dose of this medication.Get medical help right away if you experience any of the following serious side effects: diarrhea, mucus or blood in your stool, stomach pain, yellowing of skin/eyes, dark urine, unusual bleeding/bruising, unusual weakness, mouth sores, numbness/tingling in hands/feet, persistent headache, feeling cold all the time, weight gain, mental/mood changes, change in sex drive, unusual change in the amount of urine, dizziness, eye pain/redness, vision changes, fever. Uses Ipilimumab is used to treat adults with melanoma (skin cancer) that has spread or cannot be removed by surgery. It works by changing the action of your own immune system, directing it to attack skin cancer cells. Unfortunately, other body parts may also be affected (see Warning section). Ipilimumab is a type of medication called a monoclonal antibody. How to use Read the Medication Guide and Patient Wallet Card provided by your pharmacist before you start using ipilimumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Carry the Patient Wallet Card with you at all times. Show the card to all of your health care providers to let them know that you are being treated with ipilimumab.This medication is given by injection into a vein by a health care professional. It should be injected slowly over 90 minutes. It is usually given every 3 weeks for up to 4 doses, or as directed by your doctor. The dosage is based on your medical condition, weight and response to treatment.Your doctor may prescribe other medications to help with serious side effects if they occur, or your doctor may delay your dose. If the side effects lessen, then treatment with ipilimumab may continue. The goal is to complete 4 doses of ipilimumab within 16 weeks.Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder.Tell your doctor if your condition does not improve or if it worsens. Precautions Before using ipilimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, 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: history of organ transplant.This medication may worsen certain types of immune system disorders (autoimmune type). Before using this medication, tell your doctor or pharmacist if you have any of the following disorders, among others: certain bowel diseases (Crohn's disease, ulcerative colitis), Guillain-Barre syndrome, lupus, sarcoidosis.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the risks and benefits with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding. Drug interactions Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Side effects See also Warning section.Tiredness, nausea, or vomiting may occur. If any of these effects persist or worsen, tell 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 have serious side effects.A very serious allergic reaction to this drug is unlikely. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Missed dose For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Overdose If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Notes Laboratory and/or medical tests (such as liver function tests, thyroid function test) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Medical alert Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (US) or 1-800-668-1507 (Canada). Storage Not applicable. This medication is given in a clinic and will not be stored at home. Photos by medication strength Click the "Photos" link to see sample photographs for a specific medication strength. Common strengths Yervoy 200 mg/40 mL (5 mg/mL) IV Yervoy 50 mg/10 mL (5 mg/mL) IV The photos shown are samples only. Not all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist. Important note HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. Information last revised April 2011 Copyright(c) 2011 First DataBank, Inc. Intravenous Solution ipilimumab| Metastatic Malignant Melanoma| Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First DataBank, Inc., 2012. This copyrighted material has been downloaded from a licensed data provider. The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. FDA 證實 YERVOY™ (ipilimumab) 可以用於新近診斷之無法手術切除或轉移性黑色素瘤，一種死亡率極高的皮膚癌 YERVOY™ (ipilimumab)是目前唯一被証實可以使用在新近診斷之無法手術切除或轉移性黑色素瘤，具有延長病患整體存活時間，作用的機轉主要是針對CTLA-4，給予YERVOY™ (ipilimumab) 3 mg/kg 用於第三期隨機性雙盲的臨床實驗結果顯示平均存活時間在 YERVOY治療組有高達十個月,目前這項成績已經發表於New England Journal of Medicine醫學期刊上，一年存活比率46%。 YERVOY是一種人工合成的單株抗體，也是第一個FDA所証明的經由阻斷細胞毒殺Ｔ細胞淋巴球抗原四(cytotoxic T- lymphocyte antigen-4，CTLA-4)的.癌症免疫療法。CTLA-4是一種T細胞活化的負向調節劑，YERVOY結合至CTLA-4並且阻斷CTLA-4的交互作用，進而誘發免疫的抗腫瘤反應。YERVOY是由Bristol-Myers Squibb 所生產的。 YERVOY 可以因為Ｔ細胞的活化與增生所導致的嚴重甚至致死的免疫相關的副作用，這些免疫的反應會涉及到任何一個器官，然而最常見的還是小腸結腸炎、肝炎、皮膚發炎（包括了toxic epidermal necrolysis）、神經病變以及內分泌病變。大部份的免疫相關反應混在治療期間出現，然而少部份的在停止治療的時候才會出現。對於嚴重的免疫反應副作用需要停止使用 YERVOY 以及給予高劑量類固醇，所以在使用YERVOY 要特別注意以上的免疫反應以及常規的監控肝功能、甲狀腺功能。 轉移性的黑色素瘤是一種非常積極侵犯的癌症，這些年來並沒有特別的新的進展，今日 Bristol-Myers Squibb所研發的YERVOY 將是無法切除或轉移的黑色素瘤治療上的一大突破。而且作用的機轉可能是間接的，透過T細胞所媒介的對抗腫瘤免疫反應，而且藥物劑量上3 mg/kg dose的安全性是可以接受。給予藥物的方式為每三週一個療程，每次給予YERVOY (3mg/kg)靜脈輸注射藥物時間超過九十分鐘。 然而對於預後不良的族群，包括腦部轉移、LDH數值增高以及內臟器官的轉移等等，也有不錯的成績。,