Baloxavir marboxil

XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for: 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. Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. 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.

Baloxavir marboxil is an antiviral drug with activity against influenza virus.

Treatment and Post-Exposure Prophylaxis of Influenza Take XOFLUZA as a single dose as soon as possible and within 48 hours of influenza symptom onset for treatment of acute uncomplicated influenza or following contact with an individual who has influenza. XOFLUZA may be taken with or without food.

XOFLUZA is contraindicated in patients with a history of hypersensitivity to baloxavir marboxil or any of its ingredients. Serious allergic reactions have included anaphylaxis, angioedema, urticaria, and erythema multiforme.

Hypersensitivity such as anaphylaxis, angioedema, urticaria, and erythema multiforme: Initiate appropriate treatment if an allergic-like reaction occurs or is suspected. Increased incidence of Treatment-Emergent Resistance in Patients Less Than 5 Years of Age: XOFLUZA is not indicated in patients less than 5 years of age due to increased incidence of treatment-emergent resistance in this age group. In clinical trials, incidence of virus with treatment-emergent substitutions associated with reduced susceptibility to baloxavir (resistance) was higher in pediatric subjects younger than 5 years of age than older subjects. Risk of bacterial infection: Serious bacterial infections may begin with influenza-like symptoms or may coexist with, or occur as, a complication of influenza. XOFLUZA has not been shown to prevent such complications.

Adverse events reported in at least 1% of adult and adolescent influenza subjects treated with XOFLUZA included diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%). Adverse events reported in at least 5% of pediatric subjects (5 to < 12 years) treated with XOFLUZA included vomiting (5%) and diarrhea (5%).

Avoid coadministration of XOFLUZA with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc). Live attenuated influenza vaccines may be affected by antivirals.

Store tablets in their blister package at 20°C to 25°C (68°F to 77°F), excursions are permitted between 15°C and 30°C (59°F to 86°F). Storage: Store granules (bottles) at 20°C to 25°C (68°F to 77°F) and keep in the original bottle, excursions are permitted between 15°C and 30°C (59°F and 86°F). The suspension must be discarded if not used within 10 hours of preparation or if suspension has been stored above 25°C (77°F). Store reconstituted suspension no longer than 10 hours at 20°C to 25°C (68°F to 77°F) when reconstituted with drinking water or sterile water.