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VariZIG

新药编辑:新特药 更新时间:2015-02-04

  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。
  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。
  Varizig是加拿大温尼伯Cangene Corporation制造。
  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
  一般描述
  VARIZIG[水痘带状疱疹[Varicella Zoster]免疫球蛋白(人)]是一种纯制的含抗体对水痘带状疱疹病毒(anti-水痘带状疱疹病毒(VZV))人免疫球蛋白G (IgG)的溶剂/去污剂处理无菌冻干制备物。水痘带状疱疹病毒(VZV) 是水痘的致病病原体。从通过健康,被筛选有高滴度对水痘带状疱疹病毒(VZV)抗体供体捐赠的血浆制备VARIZIG,被阴离子交换色谱柱制造方法纯化。这个供体选择过程包括donors 有高抗-水痘带状疱疹病毒(VZV)滴度由于近期被水痘带状病毒感染,或由复发性带状疱疹感染。
  VARIZIG以一个含单次使用VARIZIG小瓶(为肌肉注射溶液冰冻干燥粉效价125 IU)和为给药前产品配制使用8.5 mL无菌稀释液小瓶药盒供应。VARIZIG意向单次使用和应肌肉注射[见剂量和给药方法]。
  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(5)。
  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(1)。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(2.1)
  患者体重≤2.0 kg剂量62.5 IU,小瓶数0.5;体重2.1–10.0 kg剂量125 IU,小瓶数1;体重10.1–20.0 kg剂量250 IU,小瓶数2;体重20.1–30.0 kg剂量375 IU,小瓶数3;体重30.1–40.00 kg剂量500 IU,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(2.2).
  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3 mL (2.3)。
  剂型和规格
  VARIZIG为肌肉注射溶液冻干粉供应和可得到125 IU单次使用小瓶。VARIZIG伴随有8.5 mL无菌稀释液小瓶为配制使用。建议用1.25 mL无菌稀释液配制每小瓶VARIZIG(3)。
  禁忌证
  (1)对人球蛋白过敏反应或严重全身反应史 (4).
  (2)有抗体对IgAIgA-缺陷和超敏性史患者(4).
  警告和注意事项
  (1)血栓事件 (5.1)
  (2)凝血功能障碍 (5.2)
  (3)超敏性 (5.3)
  (4)传播感染病原体 (5.4)
  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%) (6).
  为报告怀疑不良反应,联系Cangene Corporation电话1-800-768-2304或FDA电话1-800-FDA-1088或www.fda.gov/medwatch.
  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 (7).
  特殊人群中使用
  (1)妊娠: 只有明确需要才使用 (8.1)
  (2) 哺乳母亲: 应谨慎处理 (8
  临床研究
  妊娠妇女暴露于水痘带状疱疹病毒
  在60例乳胶凝集试验[latex agglutination test]确证对水痘带状疱疹病毒(VZV)无免疫力的妊娠妇女中进行一项随机化,开放,多中心,阳性对照临床试验。根据首次暴露于水痘的时间患者被分层为:(1)暴露后1至4天和(2)暴露后5至14天两层。
  妇女被随机化至以下三组之一:1)单次静脉剂量125 IU/10 kg体重至最大剂量625 IU的VARIZIG;2)单次肌肉剂量125 IU/10 kg体重至最大剂量625 IU of VARIZIG,或单次静脉剂量125 IU/10 kg体重至最大剂量625 IU的VZIG (已许可的对比产品).
  患者被随访42天。
  所有治疗组临床水痘的发生率有总体发生率33%;但是,暴露于水痘超过24小时的28例受试者子组中,组合治疗组临床水痘的发生率为64%。
  跨越所有组均数加权构成性疾病计分(CIS)(6)相似和受试者无严重水痘并发症,各治疗层少数受试者和与预先指定的假设检验缺乏一致排除正式的统计组间比较。

  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)
  LAST UPDATED:
  4/22/2013

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