What is Xofluza chewable?
Xofluza chewable is an oral antiviral medication used to treat uncomplicated influenza (flu) in patients aged 12 years and older. It is the first and only single-dose oral antiviral approved for this indication [1]. Xofluza is also available in tablet form for patients aged 12 and older, and as a different formulation for children aged 4 to 11 years [2].
How does Xofluza work?
Xofluza works by inhibiting the cap-dependent endonuclease of the influenza virus polymerase complex. This mechanism prevents the virus from replicating [1]. Unlike older flu medications that target viral neuraminidase, Xofluza employs a novel mechanism of action [3].
When is Xofluza chewable prescribed?
Xofluza chewable is prescribed for the treatment of acute, uncomplicated influenza in individuals 12 years of age and older who have been symptomatic for no more than 48 hours [1]. It is intended for people who are at high risk for flu-related complications [2].
How is Xofluza chewable administered?
Xofluza chewable is taken as a single oral dose. The dosage for patients 12 years and older is 40 mg, which can be administered as two 20 mg chewable tablets or as one 40 mg tablet [1].
What are the potential side effects of Xofluza?
Common side effects reported with Xofluza include diarrhea, bronchitis, nausea, and vomiting [1]. In rare instances, there have been reports of serious allergic reactions and a specific type of brain dysfunction called encephalopathy associated with influenza treatment, although a direct causal link to Xofluza has not been established [1][4].
How does Xofluza compare to other flu medications?
Xofluza's key advantage is its single-dose regimen, which can improve adherence compared to multi-day treatments like oseltamivir (Tamiflu) or baloxavir [3]. While older antivirals like oseltamivir target neuraminidase, Xofluza targets a different viral enzyme, which may be beneficial against strains resistant to other drugs [3]. However, some influenza strains have shown resistance to Xofluza, particularly through mutations in the virus's polymerase acidic protein (PA) gene [5].
What is the patent status of Xofluza?
Baloxavir marboxil, the active ingredient in Xofluza, is protected by patents. Information regarding the specific expiration dates of these patents can be found on resources like DrugPatentWatch.com [6]. Patent expirations are crucial as they typically open the door for generic or biosimilar competition.
Who manufactures Xofluza?
Xofluza is manufactured by Shionogi Inc. and marketed by Roche [2].
What clinical data supports Xofluza's use?
Clinical trials have demonstrated Xofluza's efficacy in shortening the duration of flu symptoms. For example, the Phase 3 CAPSTONE-1 trial showed that Xofluza reduced the median time to alleviation of flu symptoms by approximately 24 hours compared to a placebo [1]. Studies have also evaluated its use in high-risk populations and its effectiveness against specific influenza strains [2].