FDA

• Treatment of uncomplicated influenza, ages ≥ 5 years with symptoms < 48 hours.
  • Limitations of use:
    • Consider susceptibility patterns for circulating influenza virus strains when deciding whether to use baloxavir, as viruses change over time, and virus type or subtype, the emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs.
  • Baloxavir carries the FDA label for individuals at high risk (based on the Capstone 2 trial), unlike neuraminidase inhibitors (e.g., oseltamivir).
• Post-exposure prophylaxis (PEP) in patients ≥5 years