On October 24, 2018, the FDA approved XOFLUZA™ (baloxavir marboxil) for the treatment of acute, uncomplicated influenza in people 12 years of age and older. XOFLUZA is the first and only single-dose oral antiviral medicine with a novel proposed mechanism of action approved to treat the flu.
Do not take XOFLUZA if you are allergic to baloxavir marboxil or any of the ingredients in XOFLUZA.
Before you take XOFLUZA, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Talk to your healthcare provider before you receive a live flu vaccine after taking XOFLUZA.
Take Xofluza with or without food. Do not take XOFLUZA with dairy products, calcium-fortified beverages, laxatives, antacids, or oral supplements containing iron, zinc, selenium, calcium, or magnesium.
If you take too much Xofluza, go to the nearest emergency room right away.
XOFLUZA may cause serious side effects, including allergic reactions.
Get emergency medical help right away if you develop any of these signs and symptoms of an allergic reaction:
The most common side effects are diarrhea, bronchitis, sinusitis, headache, and nausea.
XOFLUZA is not effective in treating infections other than influenza. Other kinds of infections can have symptoms like those of the flu or occur along with flu and may need different kinds of treatment. Tell your healthcare provider if you feel worse or develop new symptoms during or after treatment with XOFLUZA or if your flu symptoms do not start to get better.
Please see the XOFLUZA full Prescribing Information for complete safety information.
You are encouraged to report side effects to Genentech by calling 1-888-835-2555 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
"XOFLUZA is the first new flu medicine with a novel proposed mechanism of action approved in nearly 20 years, and we’re excited to offer a convenient treatment option that reduces flu symptoms by more than a day with a single oral dose. If patients see their doctors within 48 hours of symptom onset, one dose of XOFLUZA can significantly reduce the duration of flu symptoms."