Xofluza contains the active ingredient baloxavir marboxil in its formulation, which acts as an influenza virus PA endonuclease inhibitor. It is available in the form of tablets and granules for oral suspension, with dosage strengths of 40 mg and 80 mg for tablets, and a 2 mg/mL suspension once the granules are mixed with water. Key inactive ingredients include croscarmellose sodium, lactose monohydrate, and titanium dioxide in the tablets, and mannitol and sucralose in the granules intended for suspension.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take products with calcium, iron, magnesium, selenium, or zinc in them at a different time of day than this medication. Talk to your care team if you have questions. Talk to your care team about the use of this medication in children. While it may be given to children as young as 5 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use.

Where should I keep my medication?

Keep out of the reach of children and pets. Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Diarrhea -Headache -Nausea -Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Recent or upcoming vaccine -An unusual or allergic reaction to baloxavir marboxil, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

-Antacids, vitamins, or other products that contain calcium, iron, magnesium, selenium, or zinc -Intranasal influenza vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. This medication is not a substitute for the flu shot. Talk to your care team each year about an annual flu shot.