XofluzaTM for the Treatment of Influenza

Anne M. Schwartz, Pharm.D., Avera Marshall

Now that the flu season is in full swing, it is not only important to wash your hands, but it is also important to know what treatment options are available to fight influenza. XofluzaTM (baloxavir marboxil) was recently approved for the treatment of acute, uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours. After successful clinical trials in Japan during the 2016-2017 flu season, the FDA approved baloxavir marboxil  for use in the United States on October 24, 2018.

These clinical trials resulted in similar times to alleviation of influenza symptoms compared to the current mainstay of therapy, TamifluTM (oseltamivir phosphate). However, some differences are important to note. Baloxavir marboxil was associated with greater reductions in viral load one day after initiation compared to both placebo and oseltamivir phosphate. Baloxavir marboxil also had few incidences of adverse reactions compared to oseltamivir phosphate (20.7% vs. 24.8%, respectively). Overall, these medications resulted in comparable outcomes in regard to treatment of influenza.

Baloxavir marboxil, an endonuclease inhibitor, works differently than oseltamivir phosphate, a neuraminidase inhibitor. This is beneficial as more resistant strains of influenza are emerging. It is also advantageous to have alternatives to therapy for patient-specific reasons including allergies, availability, treatment failure, and cost. With another treatment option available, healthcare professionals have an increased selection of medications to choose from to best treat patients.

An additional benefit of baloxavir marboxil is the short treatment course consisting of one tablet. This may be helpful in patients struggling with adherence compared to oseltamivir phosphate and its twice daily regimen for a total of five days. Unlike oseltamivir phosphate, baloxavir marboxil does not need to be adjusted based on renal function. On the other hand, oseltamivir phosphate is FDA approved for patients two weeks of age and older, can be used prophylactically for influenza, and comes in both a capsule and suspension formulation.

While there are many things to consider when choosing the most appropriate medication regimen to treat influenza, it is helpful to have options. The addition of another antiviral agent to treat influenza is valuable to the healthcare system and may result in better treatment outcomes.


  1. FDA news release: FDA approves new drug to treat influenza. U.S. Food and Drug Administration.  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624226.htm. Published October 24, 2018. Accessed November 14, 2018.

  2. Hayden FG, Sugaya N, Hirotsu N, et al. Baloxavir marboxil for uncomplicated influenza in adults and adolescents. N Engl J Med. 2018;379:913-923.

  3. Micromedex. Baloxavir Marboxil. www.micromedexsolutions.com. Accessed 11/14/18.

  4. Micromedex. Oseltamivir Phosphate. www.micromedexsolutions.com. Accessed 11/14/18.