Baloxavir marboxil

(Xofluza®)

Xofluza®

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Drug updated on 5/17/2024

Dosage FormTablet (oral; 40 mg, 80 mg); Suspension (oral; 40 mg/20 mL [2 mg/mL])
Drug ClassInfluenza 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.

Summary
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  • 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 TitleYearSource
Xofluza (baloxavir marboxil) Prescribing Information.2024Genentech USA, Inc., South San Francisco, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy of pharmacotherapy for seasonal influenza in young and middle-aged adults: a systematic review and network meta-analysis.2024Internal Medicine
Comparison of clinical efficacy and safety of baloxavir marboxil versus oseltamivir as the treatment for influenza virus infections: a systematic review and meta-analysis. 2023Journal of Infection and Chemotherapy
Antiviral drugs for coronavirus disease 2019 (COVID-19): a systematic review with network meta-analysis. 2022Expert Review of Anti-infective Therapy
Efficacy and safety of single-dose antiviral drugs for influenza treatment: A systematic review and network meta-analysis.2022Journal of Medical Virology
Clinical efficacy and safety of baloxavir marboxil in the treatment of influenza: a systematic review and meta-analysis of randomized controlled trials.2021Journal of Microbiology, Immunology and Infection
Comparison of antiviral agents for seasonal influenza outcomes in healthy adults and children. 2021JAMA Network Open
Neuraminidase inhibitors and single dose baloxavir are effective and safe in uncomplicated influenza: a meta-analysis of randomized controlled trials.2021Expert 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.2021Current Medical Research and Opinion
A network meta-analysis of the efficacy and safety of baloxavir marboxil versus neuraminidase inhibitors for the treatment of influenza in otherwise healthy patients.2019Current Medical Research and Opinion