部份中文奥马佐单抗处方资料（仅供参考）
英文名：Omalizumab（Genetical Recombination）
商标名：Xolair for s.c. injection
中文名：奥马佐单抗
生产商：诺华制药
ゾレア皮下注用75mg／ゾレア皮下注用150mg
药效分类
支气管哮喘治疗剂
慢性蕁麻疹治疗剂
人化抗人ige单克隆抗体制剂
批准日期：2012年11月
商標名
Xolair for s.c. injection
一般名
オマリズマブ（遺伝子組換え）
Omalizumab（Genetical Recombination）
分子量
約149,000
本質
源自人类化鼠反人类ige单克隆抗体的轻链条(c1048h1609n278o350s6;分子量:23,895.03)和重链(c2204h3389n588o673s15;分子量:49,372.00)因dna的导入，在中国仓鼠卵巢细胞中产生糖蛋白
批准条件
在制定了医药品风险管理计划之后，适当地实施。
药效药理
本药剂是人化抗人ige单克隆抗体，通过抑制ige和高亲和性接受体(fcεri)的结合，抑制好碱基球、肥胖细胞等的炎症细胞的活性化。
(1)对ige的阻碍作用
该药物将人ige和fcεri的合并竞争地阻碍，血清中游离ige的浓度减少。另外，此剂已经不与与fcεri结合的ige耦合。
(2)对于组胺游离的效果
在木草特异的ige的感作中添加本药剂，可以抑制由布太草抗原刺激人类理想碱球中的组胺游离。
(3)关于气道收缩的效果
在支气管哮喘患者中，因吸入抗原而立刻控制了哮喘反应及迟发性哮喘反应。
(4)对气道过敏性的效果
在支气管哮喘患者中，对于甲氧酶的呼吸道过敏性得到了改善。
适应症
1.支气管哮喘(只适用于因现有治疗无法控制哮喘症状的疑难杂症)
2.特发性慢性蕁麻疹(只适用于现有治疗效果不充分的患者)
用法与用量
1.支气管哮喘
通常，每隔2或4周为进行一次试剂(基因重组)，每次向皮下注射75 ~ 600mg。基于初次输入前的血清中总ige浓度以及体重，通过以下的输入量换算表来设定每一次的输入量排列以及输入间隔。
用量表(1次用量)
每隔4周注射一次
每隔两周注射一次
给药物的临床推荐用量被设定为0.008mg/kg/[iu/ml]或0.016mg/kg/[iu/ml]以上(每隔4周注射一次皮下时)。
2. 特发性慢性蕁麻疹
通常对成人和12岁以上的儿童，每隔4周就给他们注射300毫克欧马利兹玛布(基因重组)。
包装
皮下注用
75mg  1瓶
150mg  1瓶
制造销售
诺华制药公司
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明附件：http://www.info.pmda.go.jp/go/pack/2290400D1033_1_09/
XOLAIR®(omalizumab) or Injection, for Subcutaneous Use
Xolair
Pronunciation
Generic Name: omalizumab
Dosage Form: injection
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What it Treats
XOLAIR®(omalizumab) for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with:
•moderate to severe persistent asthma whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens
•chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 antihistamine treatment
XOLAIR is not used to treat other allergic conditions, other forms of urticaria, acute bronchospasm or status asthmaticus.
Important Safety Information
What is the most important information I should know about XOLAIR?
A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:
•wheezing, shortness of breath, cough, chest tightness, or trouble breathing
•low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”
•flushing, itching, hives, or feeling warm
•swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing
Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after your injection. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction after leaving the healthcare provider’s office or treatment center.
Do not receive XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.
Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you:
•have any other allergies (such as food allergy or seasonal allergies)
•have sudden breathing problems (bronchospasm)
•have ever had a severe allergic reaction called anaphylaxis
•have or have had a parasitic infection
•have or have had cancer
•are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby
•if you become pregnant while taking XOLAIR, talk to your healthcare provider about registering with the XOLAIR Pregnancy Registry. You can get more information and register by calling 1-866-4XOLAIR (1-866-496-5247) or visit www.XOLAIRpregnancyregistry.com
•are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.
How should I receive Xolair?
•Xolair should be given by your healthcare provider, in a healthcare setting
•Xolair is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks
•In asthma patients, a blood test for a substance called IgE must be performed prior to starting Xolair to determine the appropriate dose and dosing frequency. In patients with chronic hives, a blood test is not necessary to determine the dose or dosing frequency
•Do not decrease or stop taking any of your other asthma or hive medicine unless your healthcare providers tell you to
•You may not see improvement in your symptoms right away after Xolair treatment
What are the possible side effects of XOLAIR?
XOLAIR may cause serious side effects, including:
•See “What is the most important information I should know about XOLAIR?” regarding the risk of anaphylaxis
•Cancer. People who receive treatment with XOLAIR may have a higher chance for getting certain types of cancer
•Fever, muscle aches, and rash. Some people who take XOLAIR get these symptoms 1 to 5 days after receiving a XOLAIR injection. If you have any of these symptoms, tell your healthcare provider
•Parasitic infection. Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving XOLAIR. Your healthcare provider can test your stool to check if you have a parasite infection
•Some people who receive XOLAIR have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision. It is not known whether this is caused by Xolair
The most common side effects of XOLAIR:
•In people with asthma: pain especially in your arms and legs, dizziness, feeling tired, skin rash, bone fractures, and pain or discomfort of your ears
•In people with chronic idiopathic urticaria: nausea, headaches, swelling of the inside of your nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection
These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects.