2012年12月21日,美国食品药品监督管理局(FDA批准Varizig为在高危个体中当暴露后4天内给予减轻水痘(水痘带状疱疹[varicella zoster]病毒)感染的严重程度。 Varizig是一种水痘带状疱疹免疫球蛋白制备物。 水痘带状疱疹病毒(VZV)在儿童中引起水痘和在成年中带状疱疹。Varizig是在美国FDA批准的唯一可得到为 水痘带状疱疹病毒(VZV)暴露后的免疫球蛋白。它被FDA指定为孤儿药物和接到优先批准。 在美国大多数人有对水痘带状疱疹病毒(VZV)免疫力来自接种疫苗或来自儿童时曾得水痘。但是，对水痘带状疱疹病毒(VZV)没有免疫力的人们被暴露于病毒可能经受严重感染有时是致命性的。 处在风险的人们包括儿童或成年有免疫系统减弱，妊娠妇女，和妊娠期间或产后暴露的婴儿。偶尔对水痘带状疱疹病毒(VZV)无免疫力健康人可能受严重感染。抗病毒治疗不是总有效在某些情况不能使用。 美国FDA药物评价和研究中心主任Karen Midthun，M.D.说：“这个批准满足了在脆弱患者中紧迫需求提供一种为减低潜在致死性水痘感染的风险”。 研究还显示：对其意向使用是安全的，最常见副作用是注射部位疼痛和头痛。 批准日期： 2012年12月21日；公司： Cangene Corporation VARIZIG[水痘带状疱疹[Varicella Zoster] 免疫球蛋白[Immune Globulin] (人)]-只为肌肉注射给药。为注射用溶液冻干粉 美国初次批准： TBD 作用机制 VARIZIG为无-免疫个体暴露于水痘带状疱疹病毒(VZV)提供被动免疫作用，减轻水痘感染严重程度。 适应证和用途 VARIZIG是一种水痘带状疱疹免疫球蛋白(人)适用为在高危个体中暴露后预防。高危组包括： （1）免疫力低下儿童和成年， （2）分娩前或后短期有水痘新生儿母亲， （3）早产婴儿， （4）小于1岁婴儿， （5）没有免疫力的成年人， （6）妊娠妇女. 给予VARIZIG意向减低水痘严重程度。 剂量和给药方法 只为肌肉注射。 VARIZIG的给药是根据体重。建议按以下肌肉注射给予单剂量 患者体重≤2.0kg剂量62.5IU，小瓶数0.5；体重2.1–10.0kg剂量125IU，小瓶数1；体重10.1–20.0kg剂量250IU，小瓶数2；体重20.1–30.0kg剂量375IU，小瓶数3；体重30.1–40.00kg剂量500IU，小瓶数4；体重>40.1kg剂量625 IU，小瓶数5 给药前只用提供的无菌稀释液配制。遗弃剩余的无菌稀释液. 肌肉注射的量应分开在两个部位给药，依赖于患者的大小。每个注射部位不要超过3mL。 剂型和规格 VARIZIG为肌肉注射溶液冻干粉供应和可得到125IU单次使用小瓶。VARIZIG伴随有8.5mL无菌稀释液小瓶为配制使用。建议用1.25mL无菌稀释液配制每小瓶VARIZIG。 禁忌证 （1）对人球蛋白过敏反应或严重全身反应史. （2）有抗体对IgAIgA-缺陷和超敏性史患者. 警告和注意事项 （1）血栓事件 （2）凝血功能障碍 （3）超敏性 （4）传播感染病原体 不良反应 来自临床试验最常见不良反应是注射部位疼痛(2%)和头痛(2%) 药物相互作用 给予免疫球蛋白可能损害活减毒病毒疫苗的疗效；可能需要再次接种疫苗. 特殊人群中使用 （1）妊娠： 只有明确需要才使用 （2） 哺乳母亲： 应谨慎处理 VariZIG (Varicella Zoster Immune Globulin Human) is an antibody drug that is indicated for the post-exposure prevention of chickenpox in immunocompromised children, newborns and pregnant women. It was developed by Cangene Corporation, a Canada-based company. In October 2006, Cangene received approval for VariZIG in Canada for the post-exposure prevention of chickenpox in high risk patients. In January 2013, VariZIG was approved by the US Food and Drug Administration (FDA) for the reduction of the severity of chickenpox infections found in patient groups including children, pregnant women and newborns. VARIZIG Rx Pharmacological Class: Immune globulin. Active Ingredient(s): Varicella zoster immune globulin (human) 125 IU; per vial; lyophilized pwd for IM inj after reconstitution; contains <250mg of total protein (mostly human IgG), <40mcg/mL of IgA; preservative- and mercury-free. Company Cangene Corporation Indication(s): Postexposure prophylaxis of varicella in high risk individuals (include immunocompromised children and adults, newborns of mothers with varicella shortly before or after delivery, premature infants, neonates and infants <1 year old, adults without evidence of immunity, pregnant women). To reduce severity of varicella. Pharmacology: Varizig provides passive immunization for non-immune individuals exposed to varicella zoster virus (VZV), reducing the severity of varicella infections. Clinical Trials: A randomized, open-label, multi-center, active controlled clinical trial was conducted in 60 pregnant women without immunity to VZV as confirmed by latex agglutination test. Patients were stratified on the basis of time from first exposure to varicella: 1–4 days post-exposure and 5–14 days post-exposure. The women were randomized into one of three study arms as follows: (1) single Varizig 125 IU/10kg IV dose to max dose of 625 IU, (2) single Varizig 125 IU/10kg IM dose to max dose of 625 IU, or (3) single VZIG (comparator product) 125 IU/10kg IM dose to max dose of VZIG 625 IU. Patients were followed for 42 days. Incidence of clinical varicella was similar across all treatment groups with an overall incidence of 33%; however, in the subset of 28 subjects with more than 24 hours exposure to varicella, the incidence of clinical varicella in the combined treatment groups was 64%. Mean weighted constitutional illness scores (CIS) (6) were similar across all groups and none of the subjects has serious complications of varicella. The small number of subjects in each treatment stratum and the lack of agreed upon pre-specified hypothesis testing precluded formal statistical comparisons between groups. Legal Classification: Rx Contraindication(s): IgA-deficiency with IgA antibodies and history of hypersensitivity. Previous severe reaction to human immune globulin. Adults & Children: See full labeling. Administer one single-dose by IM inj ideally within 96 hours of exposure. Based on patient size: divide dose and give in ≥2 inj sites; max 3mL per inj site. Inject into deltoid muscle or anterolateral aspects of the upper thigh. Avoid gluteal region; if needed, only use upper, outer quadrant. ≤2kg: 62.5 IU; 2.1–10kg: 125 IU; 10.1–20kg: 250 IU; 20.1–30kg: 375 IU; 30.1–40kg: 500 IU; ≥40.1kg: 625 IU. Consider 2nd full dose for high risk patients with additional exposure >3 weeks after initial dose. Warnings/Precautions: Risk of thrombotic events: in patients with history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, prolonged immobilization periods, and/or known/suspected hyperviscosity. Monitor baseline blood viscosity including those with cryoglobulins, fasting chylomicronemia/markedly high triglycerides, or monoclonal gammopathies. Severe thrombocytopenia. Coagulation disorders. Risk of transmission of blood-borne diseases. Elderly. Pregnancy (Cat.C). Nursing mothers. Interaction(s) May affect response to live virus vaccines; may defer until 3 months after Varizig administration. Adverse Reaction(s) Inj site pain, headache, chills, fatigue, rash, nausea; hypersensitivity reactions (discontinue if occurs). How Supplied: Kit—1 (vial + diluent) https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac96a331-e2ff-4839-a4d5-fda3d858c969