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Outline
What is the generic name?
BALOXAVIR MARBOXIL
What is the Trade Name for BALOXAVIR MARBOXIL?
Xofluza
What are the Indications for BALOXAVIR MARBOXIL?
- 1 INDICATIONS AND USAGE XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: Treatment of acute uncomplicated influenza in patients 12 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. ( 1.1 ) Post-exposure prophylaxis of influenza in patients 12 years of age and older following contact with an individual who has influenza. ( 1.2 ) Limitations of Use Influenza viruses change over time, and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use XOFLUZA. ( 1.3 ) 1.1 Treatment of Influenza XOFLUZA is indicated for the treatment of acute uncomplicated influenza in patients 12 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 1 [see Clinical Studies (14.2) ]. 1.2 Post-Exposure Prophylaxis of Influenza XOFLUZA is indicated for post-exposure prophylaxis of influenza in persons 12 years of age and older following contact with an individual who has influenza [see Clinical Studies (14.3) ]. 1.3 Limitations of Use Influenza viruses change over time, and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use XOFLUZA [see Microbiology (12.4) and Clinical Studies (14) ] .
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References: https://open.fda.gov/
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