Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 40 mg, 80 mg); Suspension (oral; 40 mg/20 mL [2 mg/mL]) |
| Drug Class | Influenza virus polymerase acidic (PA) 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
Summary
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- Baloxavir marboxil demonstrated significant efficacy in reducing time to symptom alleviation and influenza-related complications in young and middle-aged adults, showing a reduction of -28.2 hours (95% confidence interval (CI): -42.7, -13.7) in time to symptom alleviation compared to placebo. In high-risk patients, baloxavir exhibited comparable clinical efficacy and superior antiviral activity relative to oseltamivir and peramivir, without increasing the risk of complications. Additionally, baloxavir had a lower incidence of adverse events (5.1%) compared to neuraminidase inhibitors (11%) and placebo (8.9%), indicating a favorable safety profile in various patient populations.
- Baloxavir marboxil was associated with a lower risk of any adverse events compared to oseltamivir, with an odds ratio of 0.82 (95% CI: 0.69-0.98), and compared to placebo, with an odds ratio of 0.79 (95% CI: 0.66-0.96).
- Specifically, oseltamivir was linked to higher occurrences of nausea (relative risk (RR), 1.82; 95% CI: 1.38-2.41) and vomiting (RR, 1.88; 95% CI: 1.47-2.41), while baloxavir reported adverse events in only 5.1% of recipients, lower than the 11% seen with neuraminidase inhibitors and 8.9% with placebo.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Xofluza (baloxavir marboxil) Prescribing Information. | 2024 | Genentech, Inc., South San Francisco, CA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy of Pharmacotherapy for Seasonal Influenza in Young and Middle-aged Adults: A Systematic Review and Network Meta-analysis | 2024 | Internal Medicine |
| Clinical efficacy and safety of baloxavir marboxil in the treatment of influenza: A systematic review and meta-analysis of randomized controlled trials | 2021 | Journal of Microbiology, Immunology and Infection |
| Neuraminidase inhibitors and single dose baloxavir are effective and safe in uncomplicated influenza: a meta-analysis of randomized controlled trials | 2021 | Expert Review of Clinical Pharmacology |
| Efficacy and safety of baloxavir marboxil versus neuraminidase inhibitors in the treatment of influenza virus infection in high-risk and uncomplicated patients - a Bayesian network meta-analysis | 2021 | Current Medical Research and Opinion |
| Comparison of antiviral agents for seasonal influenza outcomes in healthy adults and children. | 2021 | JAMA Network Open |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Management of influenza - updated Swedish guidelines for antiviral treatment | 2023 | Infectious Diseases |