FDA Approves New Single-dose Treatment For Influenza

October 24th, 2018

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.

News in brief

• XOFLUZA is the first and only single-dose oral medicine approved by the FDA to treat the flu, and is the first new flu medicine with a novel proposed mechanism of action approved in nearly 20 years.
• Patients now have 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, a single dose of XOFLUZA can significantly reduce the duration of flu symptoms.
• New treatment options for the flu are important. Each year, an estimated 3-11 percent of the U.S. population gets the flu, and it can be very serious, resulting in hospitalization or even death. Since 2010, the Centers for Disease Control and Prevention (CDC) estimates that the flu has resulted annually in 9.2 to 35.6 million illnesses, 140,000 to 900,000 hospitalizations and 12,000 to 80,000 deaths.

Supporting Information

Important Safety Information

What is the most important information I should know about XOFLUZA?

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.