Xofluza

Xofluza is an antiviral used to treat or prevent influenza (the flu). Xofluza is a prescription medicine FDA-approved to:

• treat the flu 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 (baloxavir marboxil) 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.

Xofluza (baloxavir marboxil) is a prodrug that is converted in the body into the active compound baloxavir. It works by blocking the flu virus's polymerase acidic (PA) endonuclease, an enzyme the virus needs to "snatch" host RNA fragments and start copying its genes. By inhibiting this influenza-specific enzyme, baloxavir stops viral gene transcription and halts replication. Resistance can arise from mutations in PA proteins. Xofluza belongs to the drug class called influenza virus polymerase acidic (PA) endonuclease inhibitors.

Xofluza (baloxavir marboxil) received FDA approval on October 24, 2018. Generic Xofluza tablets have been approved and will be available for the 2026-2027 flu season.

Take or give Xofluza exactly as directed by your healthcare provider or pharmacist.

• Your healthcare provider will prescribe Xofluza as a single, one-time dose.
• Your healthcare provider will prescribe Xofluza tablets, or Xofluza oral suspension packets or Xofluza oral suspension bottles (provided with an oral syringe).
• Your healthcare provider will prescribe Xofluza based on your or your child's weight.
• Xofluza may be given through a feeding tube that is 4 French or larger. Follow your healthcare provider's instructions for giving Xofluza through a feeding tube. Take Xofluza with or without food.
• Do not take Xofluza with dairy products, calcium-fortified beverages, laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, or zinc.
• If you take too much Xofluza, go to the nearest emergency room right away.

Xofluza for oral suspension (packets)

If your healthcare provider prescribes Xofluza for oral suspension (packets):

• See the detailed Instructions for Use for information about how to prepare and take or give a dose of Xofluza for oral suspension (packets).
• Your or your child's total prescribed dose of Xofluza for oral suspension (packets) may require preparing one or two packets of Xofluza.
• Disperse the oral granules from the Xofluza for oral suspension packets into a small container with 1 tablespoon (about 15 to 20 mL) of room temperature drinking water, and take or give the medicine right away.
• Contact your healthcare provider or pharmacist if you have any questions on how to take or give the prescribed dose of Xofluza for oral suspension (packets).

Xofluza for oral suspension (bottles)

If your healthcare provider prescribes Xofluza for oral suspension (bottles):

• The pharmacist will prepare Xofluza for oral suspension in a bottle and provide you with an oral syringe. If Xofluza is not given to you as a liquid medicine or an oral syringe was not provided, contact your pharmacist.
• Take Xofluza before the expiration time and date written by the pharmacist on the bottle label. Do not take Xofluza if the expiration time and date have passed. Throw away (discard) the bottle and contact your healthcare provider.
• Your or your child's prescribed dose of Xofluza for oral suspension may require less than one bottle, one bottle, or two bottles of Xofluza.
• The total prescribed dose of Xofluza for oral suspension may require more than one withdrawal from the bottle with the oral syringe.
• Contact your healthcare provider or pharmacist if you have any questions on how to take or give the prescribed dose of Xofluza for oral suspension (bottles).

Taking or giving a dose of Xofluza for oral suspension (bottles):

• Step 1. Swirl the Xofluza for oral suspension bottle well before each use. Do not shake.
• Step 2. Open the bottle by pushing downward on the child resistant bottle cap and twisting it in the direction of the arrow.
• Step 3. Measure the Xofluza for oral suspension with the oral syringe provided by the pharmacist to be sure you give the prescribed dose. If the prescribed dose requires more than one withdrawal from the bottle, repeat Steps 3 and 4 for each withdrawal until you take or give the full prescribed dose.
• Step 4. Take or give the full contents of the oral syringe.
• Step 5. Close the bottle. Throw away any remaining Xofluza for oral suspension and the oral syringe.

Do not take Xofluza if you are allergic to baloxavir marboxil or any of the ingredients in Xofluza. See the end of this leaflet for a complete list of ingredients in 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.

Talk to your healthcare provider before you receive a live flu vaccine after taking Xofluza.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Serious side effects

Xofluza may cause serious side effects, including:

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

Common side effects

The most common side effects of Xofluza for treatment of the flu in adults and adolescents (12 years of age and older) include:

• diarrhea
• bronchitis
• nausea
• sinusitis
• 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) include:

• vomiting
• diarrhea

Xofluza is not effective in treating or preventing 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 with Xofluza or if your flu symptoms do not start to get better.

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

Xofluza tablets:

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

Xofluza for oral suspension (packets):

• Store Xofluza for oral suspension at 68°F to 77°F (20°C to 25°C).
• Keep Xofluza for oral suspension in the original package.
• Xofluza for oral suspension in packets has no preservative.

Xofluza for oral suspension (bottles):

• Store Xofluza for oral suspension at 68°F to 77°F (20°C to 25°C). Keep Xofluza for oral suspension in the original bottle.
• Xofluza for oral suspension in a bottle has no preservative.
• Use Xofluza for oral suspension by the expiration time and date written on the bottle label. Throw away any Xofluza for oral suspension not used by the time and date on the bottle label, or if it has been stored at a temperature above 77°F (25°C).
• Xofluza for oral suspension comes in a bottle with a child-resistant cap.

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

Active ingredient: baloxavir marboxil

Xofluza tablets inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone K25, sodium stearyl fumarate, talc, and titanium dioxide.

Xofluza for oral suspension (packets and bottles) inactive ingredients: hypromellose, maltitol, mannitol, povidone K25, silicon dioxide, sodium chloride, strawberry flavor, sucralose, and talc.

Available as oral tablets (40 mg, 80 mg), packets for oral suspension (30 mg, 40 mg), bottles for oral suspension (40 mg/20 mL).

Xofluza is distributed by Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. For more information, go to www.Xofluza.com or call 1-855-XOFLUZA (1-855-963-5892).

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