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.
What is the most important information I should know about XOFLUZA?
Who should not take XOFLUZA
What should I tell my healthcare provider before using XOFLUZA?
What are the possible side effects of XOFLUZA?
Serious side effects may include
The most common side effects of XOFLUZA for treatment of the flu in adults and adolescents (12 years of age and older) were diarrhea, bronchitis, nausea, sinusitis, and headache.
The most common side effects of XOFLUZA for treatment of the flu in children (5 years of age to less than 12 years of age) were diarrhea and vomiting.
These are not all the possible side effects of XOFLUZA. Call your healthcare provider for medical advice about side effects.
XOFLUZA is not effective in treating or preventing 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.
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.
Please see full Prescribing Information, including Patient Product Information.
"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."