达菲适用范围扩展至极低龄婴儿

圣路易斯(MD Consult) -2012年12月21日，美国食品药品管理局(FDA)和基因泰克公司联合宣布扩大达菲（磷酸奥司他韦）的适用范围，允许将该药用于出生后2周以上的急性、无并发症的婴儿流感患者。

尽管已有根据体重分级计算的年龄≥1岁患儿的固定剂量方案，但对于年龄不足1岁的患儿必须根据确切体重计算用药剂量。患者应接受的治疗剂量为3 mg/Kg，每日2次，治疗5天。这种较小剂量将需要不同于当前产品包装配备的配药器。

FDA的这一决定是基于在136例年龄小于1岁的流感婴儿患者中进行的2项开放安全性与药代动力学研究。结果显示达菲对婴儿的疗效和安全特性与较大儿童和成人相似。在婴儿中报告的最常见不良反应包括呕吐和腹泻。临床试验显示，在不足1岁的婴儿中，达菲的安全特性与其他人群一致。

达菲并不能代替早期、每年1次的流感疫苗接种。美国疾病预防控制中心建议，对于所有年龄≥6个月的个体，每年均应进行1次流感疫苗接种。

爱思唯尔版权所有  未经授权请勿转载

ST LOUIS (MD Consult) - On December 21, 2012, the US Food and Drug Administration (FDA) and Genentech announced the expanded approval of Tamiflu (oseltamivir phosphate). This new approval allows Tamiflu to be used for the treatment of acute, uncomplicated influenza (flu) in infants aged 2 weeks and older.

Although a fixed dosing regimen for patients aged 1 year and older according to weight categories exists, the dosing for children younger than 1 year must be calculated for each patient based on their exact weight. These children should receive 3 mg/Kg twice daily for 5 days. These smaller doses will require a different dispenser than that which is currently copackaged with the product.

The FDA approval was granted on the basis of 2 open label safety and pharmacokinetic studies conducted in 136 infants younger than 1 year who were infected with influenza. It is expected that the drug will have a similar safety and efficacy profile to that observed in older children and adults. The most common adverse effects reported with Tamiflu use in this age group include vomiting and diarrhea. The clinical trials showed that the safety profile in infants younger than 1 year was consistent with other populations.

Tamiflu is not a substitute for early, annual flu vaccination. The US Centers of Disease Control and Prevention recommends all persons aged 6 months and older receive an annual flu vaccine.