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Generic Name: baloxavir marboxil
Dosage Form: Tablets
Date of Approval: October 24, 2018
Company: Genentech USA, Inc.

Treatment for: Influenza

Medically reviewed on Oct 30, 2018

FDA Approves Xofluza

The U.S. Food and Drug Administration (FDA) has approved Xofluza (baloxavir marboxil), a polymerase acidic (PA) endonuclease inhibitor for the treatment of acute, uncomplicated influenza (flu) in people 12 years of age and older.

Patient Information

Read this Patient Information before you start treatment. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is Xofluza?

Xofluza is a prescription medicine used to treat the flu (influenza) in people 12 years of age and older who have had flu symptoms for no more than 48 hours.

It is not known if this medicine is safe and effective in children less than 12 years of age or weighing less than 88 pounds (40 kg).

Who should not take Xofluza?

Do not take Xofluza if you are allergic to baloxavir marboxil or any of the other ingredients.

See the end of this leaflet for a complete list of ingredients.

Before taking Xofluza

Before you take 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.
  • are breastfeeding or plan to breastfeed. It is not known if Xofluza passes into your breast milk.

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.

How should I take Xofluza?

  • Take Xofluza exactly as your healthcare provider tells you to.
  • Your healthcare provider will prescribe a single dose (which may be more than one tablet).
  • Take the dose 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 or overdose, go to the nearest emergency room right away.

Xofluza side effects

The most common side effects in adults and adolescents include:

  • diarrhea
  • bronchitis
  • common cold symptoms (nasopharyngitis)
  • headache
  • nausea

Xofluza is not effective in treating infections other than influenza. Other kinds of infections can appear like 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, or if your flu symptoms do not start to get better.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800 FDA-1088.

How should I store Xofluza?

  • Store at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store tablets in the blister package that it comes in.

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Xofluza.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask for information that is written for health professionals.

What are the ingredients in Xofluza?

Active ingredient: baloxavir marboxil

Inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone, sodium stearyl fumarate, talc, and titanium dioxide.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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