From the Guidelines
Xofluza (Baloxavir) should not be used to treat influenza in a pediatric patient who is 5 years old, as the recommended antiviral medication for this age group is oseltamivir (Tamiflu) 1.
Treatment Recommendations
For a 5-year-old child, the preferred treatment for influenza is oseltamivir, which is FDA-approved for children as young as 2 weeks of age. The dosing for oseltamivir in children is based on weight, with the following recommendations:
- For children weighing less than 15 kg, the dose is 30 mg twice daily for 5 days 1.
- For children weighing more than 15 kg but less than 23 kg, the dose is 45 mg twice daily for 5 days 1.
- For children weighing more than 23 kg but less than 40 kg, the dose is 60 mg twice daily for 5 days 1.
- For children weighing more than 40 kg, the dose is 75 mg twice daily for 5 days 1.
Rationale for Not Using Xofluza
Xofluza (baloxavir marboxil) is approved by the FDA for treatment of acute uncomplicated influenza within 2 days of illness onset, but it is not recommended for children under 12 years of age due to limited safety and efficacy data in this age group 1. While Xofluza has a convenient single-dose treatment regimen, its use in young children is not supported by current evidence, and oseltamivir remains the preferred treatment option for this age group.
Additional Considerations
In addition to antiviral medication, supportive care including rest, adequate fluid intake, and fever control with acetaminophen or ibuprofen is important for managing influenza symptoms in children. It is also essential to start antiviral treatment within 48 hours of symptom onset for maximum effectiveness.
From the Research
Treatment of Influenza in Pediatric Patients with Xofluza (Baloxavir)
- Xofluza (Baloxavir) can be used to treat influenza in pediatric patients, including those aged 5 years old, as shown in studies 2, 3.
- The safety and efficacy of baloxavir in pediatric patients have been demonstrated in several studies, including a phase 3 study that included children aged 1-<12 years old 3.
- A post hoc analysis of a phase 3 study found that single-dose baloxavir was effective in treating influenza in children aged 5-11 years old, with a similar safety profile to oseltamivir 2.
- Another study found that baloxavir was well-tolerated and effective in alleviating symptoms of influenza in otherwise healthy children aged 1-<12 years old 3.
Age-Specific Considerations
- A pooled analysis of two pediatric studies conducted in Japan found that the safety and effectiveness of single-dose baloxavir were observed in children across all age groups, including those aged <6 years and ≥6 to <12 years 4.
- However, higher rates of fever recurrence and transient virus titer increase were observed in children <6 years old 4.
- A study protocol for a randomized, active-controlled trial in pediatric patients aged 6 to <12 years with influenza found that baloxavir was effective in treating influenza in this age group, with a similar safety profile to oseltamivir 5.
Dosage and Administration
- The dosage of baloxavir for pediatric patients is weight-based, with a single oral dose of 2 mg/kg for patients weighing <20 kg and 40 mg for patients weighing ≥20 kg 3.
- In Japan, the approved dose of baloxavir for pediatric patients is weight-based, with a single oral dose of 10 mg for patients weighing ≥10 to <20 kg, 20 mg for patients weighing ≥20 to <40 kg, and 40 mg for patients weighing ≥40 kg 5.