Xofluza Application Scope

Treatment: Acute uncomplicated influenza in patients aged 12 years and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications.
Post-exposure Prophylaxis: Prevention of influenza in individuals aged 12 years and older following contact with an individual who has influenza.

Xofluza Characteristics

Ingredients: Active ingredient: Baloxavir marboxil.
Properties: Baloxavir marboxil is a selective inhibitor of the influenza virus polymerase acidic (PA) endonuclease, which is essential for viral replication. It is a prodrug that is metabolized to its active form, baloxavir acid, in the body.
Packaging Specification: Available in 40 mg film-coated tablets.
Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in the original package to protect from moisture.
Expiry Date: Not specified in the provided sources; refer to the product packaging for the specific expiry date.
Executive Standard: Complies with the United States Pharmacopeia (USP) standards.
Approval Number: NDA 210854.
Date of Revision: December 2018.
Manufacturer: Genentech, Inc.

Dosage and Administration: Xofluza should be taken as a single dose as soon as possible and within 48 hours of influenza symptom onset. It can be taken with or without food.
- Recommended Dose: based on body weight:
  - 40 kg to <80 kg: 40 mg.
  - ≥80 kg: 80 mg.
- Administration: Oral tablet taken once.
- Missed Dose: If a dose is missed, take it as soon as remembered, unless it is almost time for the next dose. Do not take two doses at the same time.
Adverse Reactions:
- Common Adverse Reactions: Diarrhea, bronchitis, nausea, sinusitis, headache.
- Serious Adverse Reactions: Hypersensitivity reactions, including anaphylaxis, urticaria, angioedema, and erythema multiforme.
Contraindications: Xofluza is contraindicated in patients with a history of hypersensitivity to baloxavir marboxil or any of its ingredients.
Precautions:
- Hypersensitivity: Serious allergic reactions have been reported; appropriate treatment should be instituted if an allergic-like reaction occurs or is suspected.
- Drug Interactions: Avoid co-administration with dairy products, calcium-fortified beverages, or supplements containing calcium, iron, magnesium, selenium, aluminum, or zinc, as they may reduce the effectiveness of Xofluza.

Antacids: May reduce the effectiveness of Xofluza; avoid co-administration.
Live Vaccines: The effectiveness of live vaccines may be reduced if administered within 2 weeks before or 48 hours after taking Xofluza.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.