Drug updated on 9/4/2024
| Dosage Form | Tablet (oral; 40 mg, 80 mg); Suspension (oral; 40 mg/20 mL [2 mg/mL]) |
| Drug Class | Influenza virus polymerase acidic endonuclease inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of acute uncomplicated influenza in patients 5 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.
- Indicated for post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.
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Summary
- Xofluza (baloxavir marboxil) is indicated for the treatment of acute uncomplicated influenza in patients 5 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. It is also indicated for post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.
- This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
- Baloxavir marboxil (40 mg/day) significantly reduced the time to symptom alleviation (TTAS) by -28.2 hours compared to placebo, with similar reductions compared to laninamivir (MD = -14.67; 95% CI: [-26.75, -2.58]) and zanamivir (difference in median time 19.96 hours; 95% CrI [3.23, 39.07]), and an insignificant reduction compared to oseltamivir (MD, -1.29 hours).
- Baloxavir demonstrated a significant reduction in influenza virus titers and viral RNA loads compared to oseltamivir, placebo, zanamivir, and peramivir.
- Baloxavir was shown to be significantly more effective than placebo across all outcomes except for the risk of pneumonia in high-risk patients, and had a significantly lower incidence of adverse events in outpatients compared to oseltamivir.
- Baloxavir demonstrated a significantly lower incidence of adverse events compared to oseltamivir in outpatients and placebo, with an overall reduction in total drug-related adverse events (OR, 0.82 for oseltamivir; OR, 0.79 for placebo) and specific adverse event rates, such as 5.1% for baloxavir compared to 11% for neuraminidase inhibitors and 8.9% for placebo.
- Baloxavir was associated with the best efficacy in adverse events (SUCRA = 83.4%) and showed comparable safety to other antivirals in high-risk patients, maintaining a non-inferior safety profile relative to neuraminidase inhibitors in various populations.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Xofluza (baloxavir marboxil) Prescribing Information. | 2024 | Genentech USA, Inc., South San Francisco, CA |