Flu Treatment Now Approved for Children Aged 5 Years and Older

The FDA has approved the use of baloxavir marboxil (Xofluza) for treatment of acute uncomplicated influenza in otherwise healthy children aged 5 to less than 12 years who have been symptomatic for no more than 48 hours.

Baloxavir marboxil is the first single-dose oral influenza medication approved for children in this age group. In addition, the agency approved baloxavir marboxil for the prevention (postexposure prophylaxis) of influenza in children aged 5 to less than 12 years of age following contact with someone with influenza.

Baloxavir marboxil is a product of Genentech and was already approved to treat influenza in people 12 years of age and older who have had influenza symptoms for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. It is also approved for postexposure prophylaxis in people 12 years of age and older.

Baloxavir marboxil is not approved for use in people less than 5 years of age.

Adverse events reported in at least 5% of pediatric patients (ages 5 to 11 years) treated with baloxavir marboxil included vomiting and diarrhea. For full prescribing information, consult product labeling.