近日，瑞士制药巨头诺华（Novartis）宣布，欧盟委员会（EC）已批准Xolair（omalizumab，奥马珠单抗）预填充注射器（PFS）用于自我给药，该产品将作为一种额外的制剂，用于严重过敏性哮喘（SAA）和慢性特发性荨麻疹（CIU）患者自我注射治疗。此次批准，使Xolair PFS成为欧洲首个也是唯一一个为SAA和CSU提供自我管理（或由训练有素的护理人员管理）的生物制剂，该药适用于：（1）6岁及以上 哮喘症状难以控制的患者；（2）对H1抗组胺药物不受控的12岁及以上CSU患者。在SAA和CSU中开展的研究显示，经过适当训练的患者能够在家中有效地自我用药Xolair。   Xolair的有效性已在大规模临床研究和现实世界研究中得到证实：Xolair在SAA患者中可减少严重恶化和皮质类固醇使用，在CSU患者中可快速减少症状。EC的批准将允许无过敏史的患者自我注射或由训练有素的非专业人员从第4剂开始注射Xolair PFS，如果医生确定这是合适的话。患者或护理人员必须接受过正确的皮下注射技术和严重过敏反应的早期体征和症状识别的训练。 柏林Charité过敏中心Karl-Christian Bergmann教授表示，“今天的积极消息对IgE介导 哮喘和CSU患者的治疗而言是一个重大进步，将重塑SAA和CSU的治疗。Xolair PFS将能够减少患者定期门诊次数，使患者能够灵活地适应其生活中的治疗，并有助于减轻这些疾病的负担。此外，Xolair PFS还能使医生有更大的能力服务于需要额外护理的患者，这一点非常重要。” Xolair每2-4周注射一次，耐受性良好。由于在欧洲有13年的医生经验和100万患者暴露年，Xolair在SAA和CSU中的使用得到了来自随机临床研究和真实世界研究的大量证据的支持。过敏性反应在临床研究中（＞1/10000至＜1/1000）和上市后报告中（大约为0.2%）均是罕见的。   目前，Xolair以150mg单剂量冻干无菌粉状小瓶装销售额，这款新的Xolair PFS制剂有望在今年年底在美国市场上市，将消除卫生保健专业人员购买注射用无菌水（SWFI）以及在给药前重构Xolair注射液的需求。   Xolair是一种单克隆抗体药物，靶向结合免疫球蛋白E（IgE），该药通过皮下注射给药，可能通过减少IgE和细胞激活机制的下游效应，来抑制组胺诱导的皮肤反应。目前，Xolair已获全球90多个国家批准，以品牌名索雷尔（Xolair）上市。在美国市场，Xolair由罗氏旗下基因泰克与 诺华合作开发和推广。 在中国，Xolair（中文品牌名：茁乐，通用名：奥马珠单抗）于2017年8月获得批准，用于治疗12岁以上经吸入激素合并长效β2-肾上腺素受体激动剂治疗控制不佳的中重度过敏性哮喘患者。此次批准，使Xolair（茁乐）成为中国批准治疗 哮喘的首个靶向药物。 XOLAIR Xolair Information Xolair is a popular antibody that is known to effectively help decrease some of the most common allergic responses that occur in the patient’s organism. Therefore, this drug is highly indicated in the case of patients who are suffering from asthma (especially allergy-based asthma). Xolair Indications Xolair is a well known medical product that is generally prescribed to patients who are suffering from severe or moderate asthma. However, this medicine could also serve some other medical purposes that have not been listed in this guide. Ask your personal health care provider for more information about this medicine and its benefits. Xolair Warnings Patients whoa re suffering from known allergic reaction to this medicine should not be allowed to start taking Xolair. Furthermore, before, you are allowed to start taking this medicine, you should alert your personal health care specialist if you are allergic to any foods, dyes, preservatives or any other types of substances (this is known to include other medicines). If you also use a steroid medication, do not stop using the steroid suddenly. Patients who are following a long term treatment with this medicine are known to be more prone to developing some types of cancer such as skin, breast, salivary gland, prostate, etc. Ask your personal physician to tell you more about the risks that a treatment with this drug implies. Before you take your very first dose of this medicine, you should alert your physician if you are suffering from any other medical disorders, as you might not be allowed to start using Xolair or you might have to take smaller doses of this medicine. Your treatment with it should be closely monitored by your physician. Xolair Intake Guidelines A patient who starts a treatment with Xolair for the first time should ask his or her personal physician to tell him exactly how and when to take each dose of Xolair. Do not deviate from any of your personal doctor’s advices. If you fail to understand some of them, you should ask a pharmacist, a nurse or a physician for more detailed indications. Carefully read the set of instructions from the medicine’s label. Xolair is unable to stop an asthma attack that is already in progress, as its actions are not fast enough to reverse the attack’s symptoms. You should ask your personal physician to prescribe you a fast acting medical product for your asthma attacks. You might have to take Xolair along with some other medicines, in order to get better results from your treatment with this medicine. Do not stop using this drug without your personal physician’s approval, as this could trigger some severe symptoms. Xolair Dosage You should ask your personal health care provider to tell you the exact dose of Xolair that you should use it on a regular basis, in order to make sure that you will get the proper benefic effects from your treatment with it. Do not make any adjustments to the dose that you have been prescribed without your personal doctor’s consent. Xolair Overdose In case you suspect that you might be suffering from an overdose with Xolair you should seek medical care as soon as possible. Contact your physician and your local poison control centre as soon as possible. We have no information regarding the possible side effects that could be triggered by an overdose with this medicine, although this medical condition should not trigger any life threatening side effects or symptoms. Xolair Missed Dose In order to get the proper benefits from your treatment with Xolair, you should use this drug on a regular basis. Avoid missing any of your prescribed doses of this drug. If you happen to miss one, alert your personal health care provider and ask him or her for further advice and recommendations. Do not use double doses of this medicine, as this increases your risk of developing overdose. Xolair Side Effects Several patients who have received this medicine have suffered from an extremely dangerous life-threatening and very severe allergy to this drug’s main components. An allergic reaction to this medicine is known to occur a couple of hours after the patient has been administered this medicine. If you happen to develop any symptoms of an allergic reaction (for example skin rash or hives; light-headedness, difficulty breathing; fainting; swelling of your lips, tongue, face, or throat) you should alert your personal health care specialist as soon as possible, as you are in need of professional medical attention at once. A prolonged treatment with this medicine (Xolair) could also trigger some other severe side effects that are known to include unusual bleeding or bruising, abnormal weakness, etc. Xolair could also trigger a series of less severe but far more common side effects like: tired feeling; pain; muscle or joint pain; ear pain; hair loss; dizziness; sore throat; skin rash or mild itching; redness, warmth, pain, bruising, burning, itching, stinging, or swelling. cold symptoms. Xolair Drug Reactions Ask your personal physician to give you a list of the medicines that are known to harmfully interact with Xolair. While you are being treated with this medicine you should avoid starting to use any other topical non prescription or prescription medicines while you are following a treatment with Xolair. Buy Xolair Buy Xolair through our Online Pharmacy Escrow Service or at any Canada Pharmacy where it is sold. In some countries XOLAIR may also be known as: Omalizumab