Xofluza^®

baloxavir marboxil

Indications & Important Safety Information

What is XOFLUZA?

XOFLUZA is a prescription medicine used to:

• treat the flu (influenza) in people 5 years of age and older who have flu symptoms for no more than 48 hours and who are:
  • otherwise healthy or
  • at high risk of developing problems from the flu.
• prevent the flu in people 5 years of age and older following contact with a person who has the flu (post-exposure prophylaxis).

XOFLUZA does not treat or prevent illness that is caused by infections other than the influenza virus.

XOFLUZA does not prevent bacterial infections that may happen with the flu.

It is not known if XOFLUZA is safe and effective for the treatment and prevention of the flu in children less than 5 years of age. XOFLUZA is not for use in children less than 5 years of age.

Important Safety Information

Who should not take XOFLUZA?

• Do not take XOFLUZA if you are allergic to baloxavir marboxil or any of the ingredients in XOFLUZA.

What should I tell my healthcare provider before using XOFLUZA?

• Tell your healthcare provider about all of your medical conditions, including if you are:
  • Pregnant or plan to become pregnant. It is not known if XOFLUZA can harm your unborn baby.
  • Breastfeeding or plan to breastfeed. It is not known if XOFLUZA passes into your breast milk.
• Talk to your healthcare provider before you receive a live flu vaccine after taking XOFLUZA.
• Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, antacids, laxatives, vitamins, and herbal supplements.

What are the possible side effects of XOFLUZA?
Serious side effects may include

• Allergic reaction. Get emergency medical help right away if you develop any of the following signs or symptoms of an allergic reaction:
  • trouble breathing
  • skin rash, hives or blisters
  • swelling of your face, throat or mouth
  • dizziness or lightheadedness

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.