Side Effect Reporting

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Genentech at (888) 835-2555.

Indication

XOFLUZATM 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.

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.

Important Safety Information

Bacterial Infections

There is no evidence of efficacy of XOFLUZA in any illness caused by pathogens other than influenza viruses. 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. Prescribers should be alert to potential secondary bacterial infections and treat them as appropriate.

Drug Interactions

Co-administration with polyvalent cation-containing products may decrease plasma concentrations of baloxavir, which may reduce XOFLUZA efficacy. Avoid co-administration of XOFLUZA with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives or antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc).

Concurrent Use with Live Attenuated Influenza Vaccine

The concurrent use of XOFLUZA with intranasal live attenuated influenza vaccine (LAIV) has not been evaluated. Concurrent administration of antiviral drugs may inhibit viral replication of LAIV and thereby decrease the effectiveness of LAIV vaccination. Interactions between inactivated influenza vaccines and XOFLUZA have not been evaluated.

Most Common Adverse Reactions

Adverse events (regardless of causality assessment) reported in at least 1% of adult and adolescent subjects (n=710) who received XOFLUZA at the recommended dose included diarrhea (3%), bronchitis (2%), nausea (1%), nasopharyngitis (1%), and headache (1%).

For additional important safety information, please see XOFLUZA full prescribing information at www.XOFLUZA.com.

You are encouraged to report side effects to Genentech by calling 1-888-835-2555 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.