Baloxavir

Class: Antivirals, Miscellaneous
VA Class: AM800
Chemical Name: Carbonic acid, [[(12aR)-12-[(11S)-7,8-difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-3,4,6,8,12,12a-hexahydro-6,8-dioxo-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl]oxy]methyl methyl ester
Molecular Formula: C₂₇H₂₃F₂N₃O₇S
CAS Number: 1985606-14-1
Brands: Xofluza

Medically reviewed by Drugs.com on Oct 4, 2021. Written by ASHP.

Introduction

Antiviral; prodrug of baloxavir, a polymerase acidic (PA) endonuclease inhibitor active against influenza A and B.

Uses for Baloxavir

Treatment of Seasonal Influenza A and B Virus Infections

Treatment of acute, uncomplicated influenza caused by influenza A or B viruses in adults and adolescents ≥12 years of age who have been symptomatic for ≤48 hours, including those who are otherwise healthy and those who are at high risk for influenza-related complications. Efficacy if administered >48 hours after symptom onset not evaluated.

Data not available to date regarding use for treatment of severe or complicated influenza in hospitalized patients or outpatients.

For treatment of suspected or confirmed acute, uncomplicated seasonal influenza in otherwise healthy outpatients, CDC, IDSA, and others state that any age-appropriate influenza antiviral (oral oseltamivir, inhaled zanamivir, oral baloxavir marboxil, IV peramivir) can be used if not contraindicated. CDC states may consider early empiric antiviral treatment in outpatients with suspected influenza (e.g., influenza-like illness such as fever with either cough or sore throat) based on clinical judgement if such treatment can be initiated within 48 hours of illness onset.

For treatment of suspected or confirmed seasonal influenza in hospitalized patients or outpatients with severe, complicated, or progressive illness (e.g., pneumonia, exacerbation of underlying chronic medical conditions), CDC states oseltamivir is the preferred influenza antiviral because of lack of data regarding use of other influenza antivirals in such patients. CDC states baloxavir marboxil not recommended for treatment of influenza in hospitalized patients.

Consider that influenza and coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have overlapping signs and symptoms and coinfection with influenza A or B viruses and SARS-CoV-2 can occur. Although laboratory testing can help distinguish between influenza virus infection and SARS-CoV-2 infection, CDC recommends initiating empiric influenza treatment in patients with suspected influenza who are hospitalized, have severe, complicated, or progressive illness, or are at high risk for influenza complication without waiting for results of influenza testing, SARS-CoV-2 testing, or multiplex molecular assays that detect influenza A and B viruses and SARS-CoV- 2.

Consider viral surveillance data available from local and state health departments and CDC when selecting an antiviral for treatment of seasonal influenza. Strains of circulating influenza viruses and the antiviral susceptibility of these strains constan...