英文名称：Hizentra 20％ S.C. Injection(human immunoglobulin) 中文名称：免疫球蛋白[人]注射剂 生产厂家：CSL Behring ハイゼントラ20％皮下注１g/５mL／ハイゼントラ20％皮下注２g/10mL／ハイゼントラ20％皮下注４g/20mL 药物分类名称 血浆分离制剂（皮下注射人免疫球蛋白制剂） 批准日期：2016年11月 商標名 Hizentra 20％ S.C. Injection 1g/5mL Hizentra 20％ S.C. Injection 2g/10mL Hizentra 20％ S.C. Injection 4g/20mL 本品为含有L-脯氨酸作为稳定剂的高浓度人免疫球蛋白，为淡黄色或浅棕色透明溶液。 该药物含有50μg/ mL或更低的IgA。 IgG亚类的近似分布如下。 IgG1 62-74％ IgG 2 22-34％ IgG3 2-5％ IgG4 1-3％ 处理注意事项 因为这种药物属于特定生物制品的产品，使用该药物时，药品名称（销售名称），序列号或制造代码（批号），使用日期，使用的患者姓名， 记录地址等，并从使用之日起保存至少20年。 药用药理学 IgG功能对于Fab功能和Fc功能是已知的，并且IgG分子的Fab部分确定抗体特异性（Fab功能）。 为了使多价IgG产品具有治疗效果，必须具有生理学上有意义的抗体特异性谱，但该药物含有五种不同的特异性抗体（抗-HBs，抗脊髓灰质炎） 已经证实病毒1型，抗白喉毒素，抗细小病毒B19，抗链球菌溶血素O）。 IgG分子的Fc部分介导效应功能（Fc功能），但确认该药剂的Fc效应功能与其他市售的人免疫球蛋白制剂相同。 因此，有人提出该试剂对多种细菌和病毒因子具有广泛的光谱调理作用和中和作用，并具有适当的Fc效应子功能。 适应症 没有或低γ球蛋白血症 用法与用量 通常，每周一次皮下施用50至200mg（0.25至1mL）/kg体重的人免疫球蛋白G. 根据患者的情况，每周的剂量和给药次数应相应增加或减少。 临床结果 国内临床试验 25例原发性免疫缺陷综合征（IVIG）患者，经常接受静脉注射人免疫球蛋白制剂（IVIG）治疗（3岁至12岁以下：7例，12岁至16岁及以下：4例，17例）14岁和58岁以上的人用这种药物治疗24周。该药物每周给药一次，总共584次，功效评价期间的平均剂量为87.81mg/kg体重。 在整个功效评估期间，保持IgG谷值（平均IgG浓度7.21-7.53g/L）。 与在试验期间进行的IVIG治疗相比，转换为该药物后IgG谷值略有增加，IgG值的几何平均值的比率为1.09。 没有观察到严重的细菌感染，非严重感染的发生率为2.98次/人/年。IVIG和本产品的感染次数，住院天数，上学或工作天数以及抗生素使用年率相似。 包装 H20％皮下注射 1g/5mL 1小瓶 2g/10mL 1小瓶 4g/20mL 1小瓶 制造和销售（进口） CSL Behring 注：以上中文处方资料不够完整，使用者以原处方资料为准。 完整说明书附件：http://www.info.pmda.go.jp/go/pack/6343439A1024_1_04/ Immunoglobulin replacement therapy Hizentra approved for the treatment of primary immunodeficiency disease On March 4, 2010, CSL Behring announced that the US Food and Drug Administration (FDA) has approved Hizentra for the treatment of patients with primary immunodeficiency disease (PI). Hizentra is a subcutaneous immunoglobulin replacement therapy, which is commercially available in a 20% liquid formulation at a higher concentration than certain alternative drugs. The use of immunoglobulin replacement therapy in patients with PI may help treat existing or chronic infections and prevent new infections from occurring. The patient can be administered subcutaneously at home using a portable pump. This humanized preparation can be stored at room temperature and once a week. FDA approval of Hizentra is based on a prospective, open-label, multicenter, single-group clinical study in the United States designed to evaluate the efficacy, tolerability, and safety of Hizentra in the treatment of adult and pediatric PI patients. In the study, patients who received an intravenous immunoglobulin infusion every 3 or 4 weeks were switched to subcutaneous administration of Hizentra once a week for 15 months (3 months of wash or elution) After, followed by a 12-month efficacy period). The efficacy of Hizentra was analyzed in 38 patients who received at least 1 infusion after the wash-in or wash-out period. The most common adverse effects associated with drugs (ie, the incidence observed in clinical studies ≥ 5%) were local reactions at the injection site, headache, vomiting, pain, and fatigue. Hizentra is banned in the following populations: those with a history of allergic reactions to immunoglobulin preparations or Hizentra components or a history of severe systemic reactions; those with selective immunoglobulin A (IgA) deficiency, antibodies known to target IgA, and those with a history of allergies . In the event of an allergic reaction to a suspected Hizentra medication, the infusion should be stopped immediately and appropriate treatment should be given to the patient. Since Hizentra contains the stabilizer L-valine, it should also be banned in patients with hyperprolineemia. Hizentra is derived from human plasma. The risk of transmitting a source of infection such as a virus cannot be completely eliminated. In theory, the virus of Kreuzfeld-Jacob disease cannot be completely eliminated.