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药品英文名
Omalizumab
药品别名
Xolair
药物剂型
奥马佐单抗注射剂：含奥马佐单抗202.5mg(采用标准配置方法后，得到有效剂量为1.2ml，即150mg)，蔗糖145.5mg，盐酸L-组氨酸一水化合物2.8mg，L-组氨酸1.8mg，聚山梨醇酯200.5mg。2～8℃冰箱冷藏，避光保存。运输温度30℃以下。
注射用XOLAIR®(奥马珠单抗 omalizumab)，为皮下使用
——批准新适应证： 2014年3月21日：公司：Genentech
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150 mg。
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300mg 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。
Omalizumab Solution for injection
What is this medicine?
OMALIZUMAB (oh mah lye ZOO mab) is used to help treat allergic asthma and other allergies. It may be given with other treatments for these conditions.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
•lymphoma or other cancer
•an unusual or allergic reaction to omalizumab, hamster proteins, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding
How should I use this medicine?
This medicine is for injection under the skin. It is given by a health care professional in a hospital or clinic setting.
A special MedGuide will be given to you with each injection. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What may interact with this medicine?
Interactions are not expected.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
After receiving each injection, you will be monitored for a short time in your doctor's office or clinic.
Improvement of your asthma or allergies will not be immediate. Improvements will occur gradually.
You will have regular blood tests to determine how often you will need this medicine.
Do not stop taking any of your other asthma or allergy treatments unless otherwise directed by your doctor.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
•breathing problems
•pain, tingling, numbness in the hands or feet
•unusual bleeding or bruising
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
•headache
•mild redness, itching, swelling, or bruising at the injection site
•nausea
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
