Dosage of Xofluza

1.Dosage and Administration Overview

Baloxavir marboxil is available in two formulations:

• Baloxavir marboxil tablets (40 mg and 80 mg).

• Baloxavir marboxil oral suspension is available in two different packages: sachets (30 mg and 40 mg) and bottle (2 mg/mL). If the patient weighs less than 15 kg, the baloxavir marboxil bottle oral suspension is recommended. Both oral suspension packages are suitable for patients who are unable to swallow or have difficulty swallowing tablets, or for patients who require enteral administration.

Administer baloxavir marboxil as soon as possible after influenza symptoms appear or after influenza exposure.

Baloxavir marboxil can be taken with or without food. However, avoid co-administration of baloxavir marboxil with dairy products, calcium-fortified beverages, laxatives containing polyvalent cations, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc).

2.Recommended Dosage

Treatment of Acute Uncomplicated Influenza or Post-Exposure Prophylaxis in Adult and Pediatric Patients (5 Years of Age and Older)

Administer as a single dose as soon as possible within 48 hours of influenza symptom onset for treatment of acute uncomplicated influenza, or as soon as possible after influenza exposure for post-exposure prophylaxis.

Baloxavir Marboxil Tablets: Recommended Dosage in Adult and Pediatric Patients 5 Years of Age and Older

For patients weighing between 20 kg and less than 80 kg, the recommended single oral dose is one 40 mg tablet (blister card contains one 40 mg tablet). For patients weighing at least 80 kg, the recommended single oral dose is one 80 mg tablet (blister card contains one 80 mg tablet). The recommended dosage of baloxavir marboxil is based on patient body weight.

Baloxavir Marboxil Oral Suspension (Sachets): Recommended Dosage in Adult and Pediatric Patients 5 Years of Age and Older

For patients weighing between 15 kg and less than 20 kg, the recommended single oral dose is one 30 mg sachet. For patients weighing between 20 kg and less than 80 kg, the recommended single oral dose is one 40 mg sachet. For patients weighing at least 80 kg, the recommended single oral dose is 80 mg (two 40 mg sachets). The recommended dosage of baloxavir marboxil is based on patient body weight. Patients weighing less than 15 kg should receive baloxavir marboxil bottle oral suspension.

Baloxavir Marboxil Oral Suspension (Bottle): Recommended Dosage in Adult and Pediatric Patients 5 Years of Age and Older

For patients weighing less than 20 kg, the recommended single oral dose is 2 mg per kg body weight. For patients weighing between 20 kg and less than 80 kg, the recommended single oral dose is 40 mg (20 mL). For patients weighing at least 80 kg, the recommended single oral dose is 80 mg (40 mL). The recommended dosage of baloxavir marboxil is based on patient body weight. Use a measuring device (oral syringe) to measure the prescribed dose. Two bottles of baloxavir marboxil oral suspension are needed for the 80 mg dose.

FDA，2025.05