Patient Medication Information: uses, side effects, how to take - Xofluza
Serious warnings and precautions box
What XOFLUZA is used for:
- XOFLUZA is used to treat influenza (the flu) in patients 12 years or older who have had flu symptoms for no more than 48 hours. It is given to healthy patients or patients that are more likely to have health problems from the flu.
How XOFLUZA works:
- XOFLUZA stops the flu virus from making more copies of itself inside of your body. This will help kill the flu virus.
The ingredients in XOFLUZA are:
Medicinal ingredients: Baloxavir marboxil
Non-medicinal ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone, sodium stearyl fumarate, talc, titanium dioxide.
XOFLUZA comes in the following dosage forms:
Tablets, 20 mg, 40 mg, and 80 mg
Do not use XOFLUZA if:
- you are allergic to baloxavir marboxil or any of the non-medicinal ingredients
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take XOFLUZA. Talk about any health conditions or problems you may have, including if you:
are pregnant, planning on becoming pregnant, or are breastfeeding. XOFLUZA was not studied
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- in pregnant or breastfeeding women and the risk, if any, to your baby is not known.
Other warnings you should know about:
- XOFLUZA is only used to treat the flu caused by virus types A and type B.
- XOFLUZA is not used for treatment after 48 hours of symptoms, or for the prevention of the flu.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with XOFLUZA:
- Dairy products
- Calcium-fortified beverages
- Laxatives, antacids, and oral supplements containing iron, zinc, selenium, calcium, magnesium.
How to take XOFLUZA:
- XOFLUZA should be taken once as a single dose.
- Take XOFLUZA exactly as your healthcare professional tells you to take it.
Usual dose:
Patients 12 years of age and older: Your healthcare professional will determine your dose based on your weight:
| Body Weight (kg) | XOFLUZA dose: |
|---|---|
| 40 kg to less than 80 kg | Two 20 mg tablets OR One 40 mg tablet |
| 80 kg or more | Two 40 mg tablets OR One 80 mg tablet |
Overdose:
| If you think you, or a person you are caring for, have taken too much XOFLUZA, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed Dose:
XOFLUZA is taken as a single dose.
Possible side effects from using XOFLUZA:
These are not all the possible side effects you may feel when taking XOFLUZA. If you experience any side effects not listed here, tell your healthcare professional.
- Hives
- Diarrhea
- Nausea
- Vomiting
- Sinus infection
- Headache
- Bronchitis
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | ||||
|---|---|---|---|---|---|---|
| Only if severe | In all cases | |||||
| Unknown | ||||||
| Anaphylaxis (Allergic Reaction): difficulty swallowing or breathing, wheezing; drop in blood pressure; feeling sick to your stomach and throwing up; hives or rash; swelling of the face, lips, tongue or throat. | ✓ | |||||
| Angioedema (swelling of tissue under the skin): difficulty breathing; swollen face, hands and feet, genitals, tongue, throat; Swelling of the digestive tract causing diarrhea, nausea or vomiting. | ✓ | |||||
| Gastrointestinal disorders (Stomach and bowel problems): bloody diarrhea or dark bloody stool. | ✓ | |||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store between 15-30°C, store in the original package in order to protect from moisture.
Keep out of reach and sight of children.
If you want more information about XOFLUZA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.rochecanada.com, or by calling 1-888-762-4388.
Date of Authorization: 2025-05-27
XOFLUZA® is a registered trademark of F. Hoffmann-La Roche AG, used under license.
©Copyright 2020-2025, Hoffmann-La Roche Limited.
 | Hoffmann-La Roche Limited Mississauga, Ontario L5N 5M8 |
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