Drug updated on 3/28/2024
| Dosage Form | Tablet (oral; 40 mg, 80 mg), Oral suspension (oral; 40 mg/20 mL) |
| Drug Class | Influenza virus polymerase acidic endonuclease inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For treatment of acute uncomplicated influenza in patients 12 years of age 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.
- For post-exposure prophylaxis of influenza in patients 12 years of age and older following contact with an individual who has influenza.
Summary
- Baloxavir marboxil (Xofluza) is indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours, as well as post-exposure prophylaxis following contact with an individual who has influenza.
- A systematic review and meta-analysis showed that baloxavir was safer and more effective than oseltamivir in both outpatients and inpatients with influenza virus infections, reducing mortality rates among hospitalized patients while also shortening hospitalization periods.
- In a comparison against other antiviral drugs including lopinavir/ritonavir, triazavirin, remdesivir, zanamivir, peramivier,and laninamiver; baloxavair demonstrated superior or similar efficacy results along with a comparable safety profile.
- For high-risk patients suffering from uncomplicated influenza symptoms; single-dose administration of baloxvir proved to be non-inferior to neuraminidase inhibitors (NAIs), significantly reducing complications by up to 40% compared to placebo treatments.
- The analysis included nine Systematic Reviews / Meta-Analyses documents which collectively suggested that baloxvir is superior to placebo in terms of clinical outcome and virological response when treating influenza cases.
- Despite its effectiveness against the flu virus strains; there's currently insufficient evidence supporting the use of any antiviral drugs including Xofluza for COVID-19 according one study.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Xofluza (baloxavir marboxil) Prescribing Information. | 2023 | Genentech USA, Inc., South San Francisco, CA |