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baloxavir marboxil (Xofluza)

Indications: - treatment of influenza infection* - prevention of influenza infection* - post-exposure prevention of influenza for patients >= 12 years - prevents influenza transmission to household contacts (9.5% vs 13.4%) [8] - influenza transmissio resulting insymptoms (5.8% vs 7.6%) [8] * about as effective as oseltamivir (may be better) [2] * must be taken within 2 days of exposure Contraindications: - CDC does not recommend use of baloxavir for treatment of influenza in pregnant women, breastfeeding mothers, or immunosuppressed persons [7] Dosage: tablets granules for mixing in water Pharmacokinetics: - faster reduction of viral levels & viral shedding than oseltamivir, but little difference in alleviating symptoms - emergence of resistance to baloxavir 7.2%* * no transmission of baloxavir-resistant virus to household contacts [8] Drug interactions: - should not be co-administered foods/beverages/supplements containing calcium, iron, magnesium, selenium, aluminum or zinc. Mechanism of action: - cap-dependent endonuclease inhibitor

General

antiviral agent

Database Correlations

PUBCHEM correlations

References

  1. Smith M, North American Correspondent. Investigational Flu Drug a Near Match for Oseltamivir - Clinical outcomes 'identical' but virology different. MedPage Today. October 08, 2017 https://www.medpagetoday.com/MeetingCoverage/IDWeek/68407
  2. Hayden FG, Sugaya N, Hirotsu N Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N Engl J Med 2018; 379:913-923. Sept 6, 2018 PMID: 30184455 https://www.nejm.org/doi/full/10.1056/NEJMoa1716197
  3. Brooks M FDA OKs Xofluza, First New Flu Antiviral in Nearly 20 Years. Medscape - Oct 24, 2018. https://www.medscape.com/viewarticle/903911 - FDA News Release. Oct 24, 2018 FDA approves new drug to treat influenza. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624226.htm
  4. Brooks M FDA Expands Xofluza Indication to People at High-Risk for Flu Complications Medscape - Oct 17, 2019. https://www.medscape.com/viewarticle/920030
  5. Ikematsu H et al. Baloxavir marboxil for prophylaxis against influenza in household contacts. N Engl J Med 2020 Jul 23; 383:309. PMID: 32640124 https://www.nejm.org/doi/10.1056/NEJMoa1915341 - Uyeki TM. Baloxavir for postexposure prophylaxis against influenza in households. N Engl J Med 2020 Jul 23; 383:389 PMID: 32640147 https://www.nejm.org/doi/10.1056/NEJMe2022702
  6. FDA News Release. Nov 23, 2020 FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention. https://www.fda.gov/news-events/press-announcements/fda-expands-approval-influenza-treatment-post-exposure-prevention
  7. Bronze MS Fast Five Quiz: Influenza Practice Essentials Medscape. November 3, 2021 https://reference.medscape.com/viewarticle/962197 - Nguyen HH, Bronze MS Influenza Treatment & Management Medscape. November 5, 2021 https://emedicine.medscape.com/article/219557-treatment
  8. Monto AS et al. Efficacy of baloxavir treatment in preventing transmission of influenza. N Engl J Med 2025; 392:1582. PMID: 40267424 https://www.nejm.org/doi/10.1056/NEJMoa2413156 - Uyeki TM et al. Baloxavir treatment to reduce influenza virus transmission. N Engl J Med 2025; 392:1652 PMID: 40267433 https://www.nejm.org/doi/10.1056/NEJMe2503242