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  药店国别: 瑞士药房
产地国家: 瑞士
所属类别: 作用于呼吸系统药物->平喘药物
处方药:处方药
包装规格: 150毫克 1小瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
罗氏
生产厂家英文名:
roche
该药品相关信息网址1:
http://www.drugs.com/xolair.html
该药品相关信息网址2:
http://www.rxlist.com/xolair-drug.htm
原产地英文商品名:
XOLAIR dry subst 150 mg c solv 1 vial
原产地英文药品名:
OMALIZUMAB
中文参考商品译名:
XOLAIR 150毫克 1小瓶
中文参考药品译名:
奥马佐单抗
原产地国家批准上市年份:
2003/06/20
英文适应病症1:
Allergic asthma
英文适应病症2:
Asthma
临床试验期:
完成
中文适应病症参考翻译1:
过敏性气喘
中文适应病症参考翻译2:
哮喘
药品信息:

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 详细处方信息以本药内容附件PDF文件(200952702410016.pdf)的“原文Priscribing Information”为准
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部分中文Xolair处方资料(仅供参考)

【介绍】:Omalizumab (Xolair®)
omalizumab与药物或疫苗交互作用的试验。但就药理学的观点来看,一般处方用于治疗气喘的药品和omalizumab预期并不会产生交互作用3。必须特别注意的是,omalizubmab不适用于治疗急性气喘恶化,急性支气管痉挛或气喘重积症。 Omalizumub一般常见( >10 % )的副作用包括有:注射部位疼痛、红肿、搔痒(轻度45 %,重度12 % ) 、病毒性疾病( 23 % ) 、上呼吸道感染( 20 % ) 、窦炎( 16 % ) 、头痛( 15 % ) 、咽喉炎( 11 % ) 。而不常见( 1-10 % )的副作用包括有:疼痛、疲劳、头昏眼花、皮肤炎、搔痒、关节痛、手臂与腿部疼痛、骨折和耳痛。罕见( <1 % )副作用包括:秃头、过敏性反应( 0.1-0.2 % ) 、恶性肿瘤( 0.5 % ) 、喉头或舌头水肿、血小板减少症和荨麻疹7。另外,由于每剂150毫克的omalizumab含有108毫克的蔗糖,所以应事先告知患有糖尿病、葡萄糖-半乳糖吸收不良症、果糖不耐性或缺乏蔗糖¬异麦芽糖酶的病人3

【药理作用】
当IgE和巨细胞及嗜碱细胞表面具高亲和力的FcεRI接受体结合,并和过敏原交叉连结时,会开始启动过敏反应,导致这些作用细胞去颗粒化而释出组织胺、白三烯素、细胞激素( cytokines )及其他媒介物质。这些媒介物质和过敏性气喘的病理生理学相关,包括呼吸道肿胀、平滑肌收缩及改变与发炎过程相关的细胞活性,并造成过敏性疾病的症状,例如支气管收缩、黏液产生、哮喘、呼吸困难、胸部紧绷、鼻塞、打喷嚏、搔痒、流鼻水及鼻痒、流眼泪。
Omalizumab为基因重组的类人化单株抗体,可选择性与人类IgE结合。此抗体为kappa免疫球蛋白G1 ( IgG1 kappa ) ,含有人类基本架构区及可与IgE结合的啮齿类互补决定区。当omalizumab和IgE结合后,可以防止IgE和高亲和力的FcεRI接受体结合,因此减少了可以启动过敏反应的游离IgE量3 。 Omalizumab的治闻用在遗传性过敏症病人的身上也会减少嗜碱细胞上IgE接受体的数量4。

【药动学特性】
皮下投与omalizumab吸收后的平均绝对生体可用率为62 %。在患有气喘的成人及青少年皮下单一剂量投与后,omalizumab的吸收缓慢,平均于7-8天后达最高血中浓度。 Omalizumab的药物动力学在剂量大于0.5毫克/公斤时呈线性。多次投与omalizumab后,于稳定状态下自第0天至第14天血清浓度-时间曲线下面积达到初始剂量的6倍。在体外试验,omalizumab与IgE形成有限大小的复合物。于体外或体内并无观察到沉淀复合物及大于一百万道尔顿( Dalton )的复合物。于猕猴组织分布试验显示无任何器官或组织特定的摄取125I-omalizumab 。病人于皮下投与后的拟分布体积为78±32毫升/公斤。 Omalizumab的清除方式包括药物本身IgG的清除以及与IgE形成复合物后的清除等机转。肝脏清除IgG的方式包括在网状内皮组织系统( RES )及内皮状细胞中的破坏。完整的IgG亦会被分泌于胆汁中。在小鼠与猴子的试验当中,omalizumab:IgE复合物于小鼠体内是藉由RES的Fcγ接受器的交互作用而排除,通常较IgG的排除为快。在气喘病人,omalizumab血清排除半衰期平均为26天,拟清除率平均为2.4±1.1毫升/公斤/天。另外,体重加倍清除率亦大约加倍3。

【适应症】
Omalizumab为附加疗法用于改善已接受高剂量吸入性类固醇制剂及长效乙二型作用剂治疗下仍有频繁的日间症状或夜间觉醒且具有多次重度气喘恶化记录的重度持续过敏性气喘成人与青少年( 1 2岁以上)的气喘控制。这些气喘患者必须有经由皮肤测试或体外试验显示长期空气对中过敏原呈阳性且肺功能降低( FEV1 <80 % ) 。 Omalizumab仅适用于证实为IgE媒介型的气喘病人3。

【用法用量】
Omalizumab仅适用于青少年及成人( 12岁或大于12岁) 。其适当的给药剂量和频率是根据开始治疗前IgE (国际单位/毫升)的测量基底值及体重(公斤)而定。建议给药剂量请参阅表二、表三。 IgE基底值或体重(公斤)在剂量对应表之外的病患不可投与omalizumab 。由于omalizumab治疗期间和停止治疗1年后,其总IgE的浓度仍持续升高。因此治疗期间再次检验之IgE值不可作为决定剂量的指标。中止治疗未达一年,剂量订定应以初始治疗剂量所测得的血清IgE浓度为基准。若终止治疗达一年以上,则需再次测定总血清IgE值以订定剂量。另外,omalizumab仅供皮下注射,不得以静脉注射或肌肉注射方式投与3。

【药物安全性】
Omalizumab的清除与细胞色素P450酵素,排出唧筒( cefflur pumps )及蛋白质的结合机转无关,因此与药物产生交互作用的可能很低。

Xolair (Omalizumab)
Xolair (generic name omalizumab) is a medication used to treat allergic asthma. This medication acts on the body's immune system to decrease the allergic response to a trigger substance, such as pet dander, mites, dust or cockroach debris.

Who Can Benefit From Xolair?
People with moderate to severe asthma and those people whose asthma is largely related to allergies can usually benefit from Xolair. This prescribed medicine is only recommended secondary to other medicine(s). It is primarily used for people whose symptoms continue despite standard asthma treatments, such as high-dose inhaled corticosteroids and a long-acting beta-agonist.

In people with moderate to severe asthma with a large allergic component, Xolair has been shown to reduce severe asthma attacks and the number of emergency room visits. The drug is given by injection every two to four weeks, depending on the needs of the patient.

How Does Xolair Work?
Exactly how allergy-induced asthma develops is unclear, but it does seem to involve the immune system. When an irritant substance (trigger) is inhaled, the immune system in the airways activates an antibody response over time. This response causes inflammation or swelling of the breathing tubes, constriction of the surrounding muscles and extra mucus production. These changes cause standard asthma symptoms of difficulty in breathing, coughing, wheezing and chest tightness.

The drug interferes with this response by the body, and this stops the cascade of events that lead to the symptoms of asthma.

Side Effects of Xolair
Xolair can cause a rare but serious side effect called anaphylaxis. This is a severe allergic reaction that can be rapidly fatal if not treated appropriately and quickly. Only a small number of people (0.2%) who use this drug will ever experience an anaphylactic reaction, but this risk is serious enough that the drug must be given in a doctor's office. The patient may even need to be observed for a few hours after the first several injections.

Some people have allergic reactions to the drug many hours after, so anyone who is treated with Xolair should be given an Epi-Pen and instructions on how to use it. This prefilled syringe contains epinephrine, which is used in case of a severe allergic reaction.

Other side effects of the medication include discomfort at the injection site, skin redness and bumps. One finding of concern, though not yet completely understood, is that twice as many patients receiving this medication were found to have cancer when compared to a group of patients who received a placebo. Although the number of people in each group who had developed cancer were small, the types of cancer varied widely. At this time, it is unclear if there is a relationship between omalizumab injections and cancer.

Xolair is approved for use only in people 12 years of age and older. There have been no studies concerning the use of this medication in pregnancy. Therefore, any woman who is pregnant or trying to conceive should consult her doctor about using this medication.

Ask your doctor if Xolair might help if you have any of the following conditions:
•uncontrollable asthma
•allergies with uncontrollable asthma, despite regular use of appropriate medications
•controllable asthma, due to frequent use of steroid medication

Xolair can be prescribed by a primary care doctor. If your primary care doctor is not familiar with it, then a referral can be made to a doctor specializing in allergies or lung disease.

You can learn even more about Xolair (and other medicines), including how it might interact with other medications, at our Drugs A to Z page.

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 详细处方信息以本药内容附件PDF文件(200952702410016.pdf)的“原文Priscribing Information”为准
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更新日期: 2019-1-10
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200952702410016.pdf    

 
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