Varizeg获准用于减轻高危患者水痘

圣路易斯(MD Consult) -2012年12月21日，美国食品药品管理局(FDA)宣布，水痘带状疱疹免疫球蛋白制剂Varizeg已通过核准，用于降低发生重度感染高危患者的水痘严重程度。需要在暴露后4天内给予这种药物。

Varizig是一种取材于健康捐赠者血浆的抗体制剂，具有很高的抗水痘带状疱疹病毒(VZV)抗体水平。捐赠血浆来自美国和加拿大的经FDA认证的收集机构。在暴露后96 h内，根据受者的体重，需要给予Varizig注射2次或2次以上。已核准将Varizig用于免疫受损的儿童和成人、新生儿、妊娠妇女、早产儿、不足1岁的婴儿和对VZV无免疫力的成人。

研究显示，Varizig与水痘带状疱疹免疫球蛋白(VZIG)相似，VZIG是较早的一种经FDA核准的产品，已于2006年被撤出美国市场。Varizig预防孕期感染与VZIG同样有效。在扩大准入协议下接受治疗的个体中收集的关于Varizig的数据显示，在易感人群中，接受Varizig治疗者的重度VZV感染发生率低于未经治疗者。这些研究还显示，将Varizig用于意向用途的安全性良好，最常见的不良反应为注射部位疼痛和头痛。

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ST LOUIS (MD Consult) - On December 21, 2012, the US Food and Drug Administration (FDA) announced the approval of Varizeg, a varicella zoster immune globulin preparation. The product is indicated for reducing the severity of chicken pox in persons at high risk of experiencing a severe infection. The product needs to be given within 4 days after exposure.

Varizig is an antibody preparation manufactured from the plasma of healthy donors with high anti-varicella zoster virus (VZV) antibody levels. The donated plasma comes from FDA-licensed collection facilities in the United States and Canada. Varizig is administered in 2 or more injections, depending on the weight of the recipient, within 96 hours after exposure. Varizig is approved for use in immunocompromised children and adults, newborns, pregnant women, premature infants, children younger than 1 year, and adults with no immunity to VZV.

In studies, Varizig was shown to be comparable with varicella zoster immune globulin (VZIG)-an earlier FDA-licensed product that was removed from the US market by the manufacturer in 2006-and was as effective as VZIG in preventing infection during pregnancy. Data on Varizig collected from persons treated under an expanded access protocol showed a low rate of severe VZV infection in susceptible persons compared with the rate in untreated persons. The studies also showed that Varizig is safe for its intended use, with the most common adverse effects being pain at the injection site and headache.