Drug updated on 5/17/2024
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.
Latest News
![loading GIF](/img/news-loading.gif)
Summary
- Baloxavir marboxil (Xofluza) is indicated for the treatment of acute uncomplicated influenza in patients 5 years and older who have been symptomatic for no more than 48 hours. It is also used as post-exposure prophylaxis following contact with an individual who has influenza.
- A review of nine studies was conducted to compare the safety and effectiveness of baloxavir marboxil against other antiviral drugs for otherwise healthy individuals and high-risk patients with influenza.
- This medication significantly reduces the time to symptom alleviation in healthy young adults, shortens hospitalization periods, lowers mortality among inpatients, reduces illness duration among outpatients, and exhibits fewer gastrointestinal side effects compared to other treatments.
- For high-risk patients specifically, baloxavir marboxil shows comparable efficacy in symptom alleviation but superior antiviral activity by achieving a significant decline in virus titer from baseline at 24 hours after treatment when compared to oseltamivir or peramivir.
- Compared with neuraminidase inhibitors (NAIs) and single-dose antiviral drugs like peramivir, baloxavir demonstrates superior efficacy regarding the time taken for symptom relief while lowering virus titer variations alongside better adverse event profiles.
- Baloxavir presents a lower risk of total adverse events compared with placebo, indicating its favorable safety profile; it also notably reduced the rate of complications related to the flu, positioning it as an effective alternative treatment option with fewer side effects.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Xofluza (baloxavir marboxil) Prescribing Information. | 2024 | Genentech USA, Inc., South San Francisco, CA |