英文药名：Xolair(Omalizumab for s.c. injection) 中文药名：奥马珠单抗注射剂 生产厂家：瑞士诺华日本公司 给药说明 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150mg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150mg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。 XOLAIR®(omalizumab) or Injection, for Subcutaneous Use Xolair Pronunciation Generic Name: omalizumab Dosage Form: injection ---------------------------------- 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. You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682. http://www.info.pmda.go.jp/go/pack/2290400D1033_1_05/ ------------------------------------------ 产地国家: 日本 原产地英文商品名: XOLAIR for s.c. injection（ゾレア皮下注用）75mg/Vial 原产地英文药品名: OMALIZUMAB 中文参考商品译名: XOLAIR（ゾレア皮下注用）75毫克/瓶 中文参考药品译名: 奥马佐单抗 生产厂家中文参考译名: 瑞士诺华 生产厂家英文名: Novartis ------------------------------------------ 产地国家: 日本 原产地英文商品名: XOLAIR for s.c. injection（ゾレア皮下注用）75mg/Vial 原产地英文药品名: OMALIZUMAB 中文参考商品译名: XOLAIR（ゾレア皮下注用）75毫克/瓶 中文参考药品译名: 奥马佐单抗 生产厂家中文参考译名: 瑞士诺华 生产厂家英文名: Novartis ------------------------------------------ 产地国家: 西班牙 原产地英文商品名: XOLAIR 150mg/Vial 原产地英文药品名: OMALIZUMAB 中文参考商品译名: XOLAIR 150毫克/瓶 中文参考药品译名: 奥马佐单抗 生产厂家中文参考译名: 瑞士诺华 生产厂家英文名: Novartis ------------------------------------------ 产地国家: 西班牙 原产地英文商品名: XOLAIR 150mg/Vial 原产地英文药品名: OMALIZUMAB 中文参考商品译名: XOLAIR 150毫克/瓶 中文参考药品译名: 奥马佐单抗 生产厂家中文参考译名: 瑞士诺华 生产厂家英文名: Novartis ------------------------------------------ 产地国家: 美国 原产地英文商品名: XOLAIR 150mg/Vial 原产地英文药品名: OMALIZUMAB 中文参考商品译名: XOLAIR 150毫克/瓶 中文参考药品译名: 奥马佐单抗 生产厂家中文参考译名: 基因技术公司 生产厂家英文名: Genentech