部份中文奥马珠单抗处方资料（仅供参考）
【通用名称】 索雷尔Xolair
【英文名称】 Xolair(Omalizumab injection)
【中文名称】 索雷尔，奥马珠单抗注射剂
【批准日期】2014年3月21日
【生产厂家】Genentech/Novartis Pharma
【作用机制】
过敏性哮喘 奥马珠单抗抑制IgE与在肥大细胞和嗜碱性粒细胞表面高亲和力IgE受体(FcεRI)的结合。减低FcεRI-携带细胞上表面结合的IgE限制过敏性反应的介导物释放的程度。在特应性[atopic]患者中用Xolair治疗还减低嗜碱性粒细胞上FcεRI受体数。
慢性特发性荨麻疹 奥马珠单抗结合至IgE和减低游离IgE水平。随后地，细胞上IgE受体(FcεRI)下调。通过奥马珠单抗这些效应导致慢性特发性荨麻疹CIU症状改善机制不知道。
【适应证和用途】
Xolair是一种抗-IgE抗体适用为：
⑴ 用皮试阳性或体外对常年吸入性过敏原反应性和症状用吸入性皮质激素控制不佳中度至严重持续性哮喘的患者。
⑵ 尽管H1抗组织胺治疗仍保留症状性的慢性特发性荨麻疹成年和青少年(12岁和以上)。
【使用的重要限制】：
⑴ 不适用为其他过敏性疾病或其他型式的荨麻疹。
⑵ 不适用为急性支气管痉挛或哮喘持续状态。
⑶ 不适用为小于12岁儿童患者。
【剂量和给药方法】
只为皮下(SC)给予。
超过150 mg时分剂量多于一个注射部位以限制每个部位不超过150mg。
⑴ 过敏性哮喘：Xolair 150至375 mg SC每2或4周。通过治疗开始前测量血清总IgE水平(IU/mL) 和体重(kg)确定剂量(mg)和给药频数。见剂量测定图表。
⑵ 慢性特发性荨麻疹(Chronic idiopathic urticaria)：Xolair 150或300 mg SC每4周。在CIU中给药不依赖于血清IgE水平或体重。
【剂型和规格】在单次使用5mL小瓶中150 mg冻干无菌粉。
【禁忌证】对Xolair或Xolair的任何成分严重超敏反应。
【警告和注意事项】
⑴ 过敏性反应—只在卫生保健情况给予准备处理可能是危及生命过敏性反应和给药后观察患者适当时间。
⑵ 恶性病—在临床研究中曾观察到恶性病。
⑶ 急性哮喘症状—急性支气管痉挛或哮喘持续状态不要使用治疗。
⑷ 皮质激素类减量—Xolair治疗开始不要突然终止皮质激素。
⑸ 发热，关节痛，和皮疹—如患者发生相似于血清病体征和症状停止Xolair。
⑹ 嗜酸性情况—警戒嗜酸粒细胞增多，血管炎性皮疹，肺部症状恶化，心脏并发症，和/或神经病变，特别是口服皮质激素减少时。
【不良反应】
⑴ 过敏性哮喘：最常见不良反应(在Xolair-治疗患者中较频≥1%)在临床研究是关节痛，疼痛(一般性)，腿痛，疲劳，眩晕，骨折，手臂疼痛，瘙痒，皮炎，和耳痛。
⑵ 慢性特发性荨麻疹：最常见不良事件(≥2% Xolair-治疗患者和比安慰剂更频)包括以下：恶心，鼻咽炎，窦炎，上呼吸道感染，病毒性上呼吸道感染，关节痛，头痛，和咳嗽。
【药物相互作用】未进行正式药物相互作用研究。 
INDICATION
XOLAIR® (omalizumab) for subcutaneous use is indicated for adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.
XOLAIR has been shown to decrease the incidence of asthma exacerbations in these patients.
Important Limitations of Use 
  XOLAIR is not indicated for treatment of other allergic conditions
  XOLAIR is not indicated for the relief of acute bronchospasm or
status asthmaticus
  XOLAIR is not indicated for use in pediatric patients less than
12 years of age
IMPORTANT SAFETY INFORMATION
WARNING: Anaphylaxis
Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, observe patients closely for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur (see Warnings and Precautions: Anaphylaxis).
 XOLAIR should only be administered in a healthcare setting by healthcare providers prepared to manage anaphylaxis that can be life-threatening.
  XOLAIR should not be administered to patients who have experienced a severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR (see Warnings and Precautions). XOLAIR should be discontinued in patients who experience a severe hypersensitivity reaction.
  Malignant neoplasms were observed in 20 of 4127 (0.5%) XOLAIR-treated patients compared with 5 of 2236 (0.2%) control patients in clinical studies of asthma and other allergic disorders.
  XOLAIR has not been shown to alleviate asthma exacerbations acutely. Do not use XOLAIR to treat acute bronchospasm or status asthmaticus.
  A constellation of signs and symptoms including arthritis/arthralgia, rash (urticaria or other forms), fever and lymphadenopathy similar to serum sickness have been reported in post-approval use of XOLAIR in some patients. Physicians should stop XOLAIR if a patient develops this constellation of signs and symptoms.
  Patients should be given and instructed to read the accompanying Medication Guide before starting treatment and before each subsequent treatment.
  Do not abruptly discontinue corticosteroid use upon initiation of XOLAIR therapy. Decrease corticosteroids gradually under the direct supervision of a physician.
  In patients ≥12 years of age, the most commonly observed adverse reactions (>1% more frequent in XOLAIR-treated patients) from 4 placebo-controlled asthma studies were arthralgia (8%), pain (general) (7%), leg pain (4%), fatigue (3%), dizziness (3%), fracture (2%), arm pain (2%), pruritus (2%), dermatitis (2%), and earache (2%).
  The adverse events most frequently resulting in clinical intervention (e.g. discontinuation of XOLAIR, or the need for concomitant medication to treat an adverse event), in either placebo-controlled or other controlled asthma studies, were injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). These events were observed at similar rates in XOLAIR-treated patients and control patients.
欧盟批准诺华公司抗哮喘药omalizumab(Xolair)上市
诺华公司（Novartis）宣布，欧盟委员会已经批准其抗哮喘药omalizumab（Xolair）在欧盟25个成员国上市。本品有望在未来几周内在欧盟国家上市。许多专家认为，本品是最近15年中哮喘治疗方面最重要的进步之一，欧盟是在考虑了这些专家意见之后给予本品上市授权的。
本品的独特作用机制为哮喘患者提供了一种新型注射疗法，能够有效控制哮喘发作以及现有疗法尚未控制的症状。
作为首个获准用于哮喘治疗的单克隆抗体，本品具有独特的治疗途径——能够阻断IgE的作用。
在欧洲，本品获准作为附加疗法用于改善严重持续性变应性哮喘患者的哮喘控制。适用本品的患者应是成人和12岁及以上青少年，除了接受高剂量吸入糖皮质激素加长效吸入β2-激动剂治疗，还应具备下列条件：
    1、皮肤试验或体外检测显示对常年性气源性致敏原呈阳性；
    2、肺功能降低（FEV1<80%）；
    3、频发日间症状或夜间觉醒；
    4、多次记录严重哮喘加重发作。
    此外，本品仅考虑用于确诊的IgE介导型哮喘。
本品通过皮下注射给药，每二周或四周注射1次。临床研究显示，本品能显著降低哮喘加重发作率，并使严重哮喘患者的急诊率减半。即使是采用现有最好疗法仍未能得到足够控制（甚至因此而出现致命性发作）的哮喘患者，在使用本品后仍可以获得治疗益处。本品已于2003年6月获得了美国FDA的批准。
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