Baloxavir: A Novel Single-Dose Oral Antiviral for the Treatment of Influenza.

Abstract

OBJECTIVE: To review the pharmacology, pharmacokinetics, pharmacodynamics, clinical efficacy, tolerability, dosing, and administration of baloxavir marboxil (BXM), as well as its place in the treatment of influenza.<br/> DATA SOURCES: A search of PubMed and Google Scholar using the terms "baloxavir" and "S-033188" was performed. The manufacturer's website was also reviewed to further identify relevant information.<br/> STUDY SELECTION/DATA EXTRACTION: All Englishlanguage articles from January 2008 to December 2018 appearing in these searches were reviewed for relevance to this paper. In addition, their bibliographies were reviewed to identify any articles not identified in the searches.<br/> DATA SYNTHESIS: BXM is a selective cap-dependent endonuclease inhibitor approved by the Food and Drug Administration for the treatment of acute uncomplicated influenza in adults and adolescents 12 years of age and older who weigh at least 40 kg. Clinical trials demonstrated that BXM was associated with a significantly shorter time to alleviation of influenza symptoms compared with placebo when taken within 48 hours of symptom onset. The time to alleviation of symptoms was similar with BXM and oseltamivir. The most common adverse reactions associated with BXM were diarrhea, bronchitis, nausea, nasopharyngitis, and headache. BXM is administered orally as a single-dose of 40 mg or 80 mg, depending on body weight. No dosage adjustment is needed in patients with mild-to-moderate hepatic or renal impairment.<br/> CONCLUSION: BXM has been proven safe and effective in the treatment of acute uncomplicated influenza in patients 12 years of age and older when administered within 48 hours of symptom onset.