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These highlights do not include all the information needed to use XOFLUZA safely and effectively. See full prescribing information for XOFLUZA. XOFLUZA® (baloxavir marboxil) tablets, for oral use XOFLUZA® (baloxavir marboxil) for oral suspension Initial U.S. Approval: 2018
Medication labelWhy this: Advisory · dailymed-prescription
XOFLUZA is indicated for treatment of acute uncomplicated influenza in patients 5 years of age 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 complications1 [see Clinical Studies (14.1, 14.2, and 14.3]. XOFLUZA is indicated for post-exposure prophylaxis of influenza in persons 5 years of age and older following contact with an individual who has influenza [see Clinical Studies (14.4)]. Influenza viruses change over time, and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use XOFLUZA [see Warnings and Precautions (5.2), Microbiology (12.4) and Clinical Studies (14)].
- generic_name
- baloxavir marboxil
- product_names
- BALOXAVIR MARBOXIL, Baloxavir Marboxil
- ndc
- 50242-583, 50242-860, 50242-877, 50242-860-01, 50242-860-86, 50242-583-01, 50242-877-01, 50242-877-86, 50242-599, 50242-599-01, 50242-617, 50242-617-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en