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Indications of Xofluza

1. Influenza Treatment

Baloxavir marboxil is indicated for the treatment of acute uncomplicated influenza in patients 5 years and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications.

2. Influenza Post-Exposure Prophylaxis

Baloxavir marboxil is indicated for post-exposure prophylaxis of influenza in individuals 5 years and older following contact with a patient with influenza.

3. Limitations of Use

Influenza viruses change over time, and factors such as the emergence of viral types or subtypes, the development of resistance, or changes in viral virulence may reduce the clinical benefit of antiviral drugs. When deciding whether to use baloxavir marboxil, consideration should be given to available information on drug susceptibility patterns of circulating influenza virus strains.

FDA，2025.05