For Patients and Caregivers

Recognize and Treat the Flu Promptly With an Antiviral*

How effective is vaccination against the flu?

Despite their availability and essential role in flu prevention, flu vaccines are not always used or are not always effective, leaving millions of people at risk.9

In the 2019-2020 flu season, vaccination coverage across the United States was only 48% for adults and 53% for adolescents aged 13 to 17 years.18

In the 2019-2020 flu season, the adjusted estimated vaccine effectiveness against the influenza A and B viruses was only 39%. Vaccine effectiveness has varied from 19% to 60% over the 2009-2020 flu seasons.19,20

Flu (Influenza) Vaccine Efficacy Against Predominant Strains
Influenza antivirals have been shown to shorten the duration of flu symptoms.15

What serious risks are associated with the flu?

Most patients who get the flu recover in 3 to 14 days, but influenza can cause complications that could be life threatening.4,10

For high-risk patients, the dangers of the flu are even greater and can lead to serious complications or even death.4,10

How is the flu different from a cold or COVID-19?10,21-28†

The below table can serve as a convenient reference for summarizing the differences between the flu, the common cold, and COVID-19.

Chart comparing possible symptoms of the flu, the common cold and COVID-19.

Some symptoms of the flu can be quite similar to and/or overlap with the typical symptoms of COVID-19 and the common cold.21,22

When there is a clinical diagnosis of flu or suspected flu, the CDC recommends treating flu patients empirically—especially those at high risk for developing complications—with an antiviral flu treatment. Empiric antiviral treatment is also recommended for non–high-risk outpatients with suspected influenza based on clinical judgment, including without an office visit, in communities where influenza is circulating.15‡

The CDC updates its Antiviral and Treatment Recommendations every year and has included XOFLUZA among its list of antiviral medications recommended for the flu.15‡

*Treating with single-dose XOFLUZA promptly (within 48 hours of symptom onset) can help alleviate flu symptoms.1

†Single-dose XOFLUZA does not treat COVID-19 or the common cold.
‡Source: Centers for Disease Control and Prevention (CDC). The CDC does not endorse private products, services, or enterprises. The content provided is for informational purposes only. Find the latest at CDC.gov.

XOFLUZA® (baloxavir marboxil) Safety Icon

Help Prevent the Flu


Patients can reduce their risk of contracting the flu after exposure to an infected household member by taking single-dose XOFLUZA.

Post-exposure prophylaxis efficacy

Indication

XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor 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

XOFLUZA is also indicated for post-exposure prophylaxis (PEP) of influenza in patients 12 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.

Important Safety Information

Contraindications
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.

 

Warnings and Precautions

Hypersensitivity: Cases of anaphylaxis, urticaria, angioedema, and erythema multiforme have been reported in postmarketing experience with XOFLUZA.  Appropriate treatment should be instituted if an allergic-like reaction occurs or is suspected.

 

Risk of bacterial Infections: There is no evidence of the 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.

Adverse Reactions
The most common adverse reactions (≥1%) in clinical studies for acute uncomplicated influenza were diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%).


The most common adverse reaction in a clinical study for post-exposure prophylaxis (PEP) was nasopharyngitis (6%).

 

Drug Interactions

Polyvalent cations: Coadministration with polyvalent cation-containing products may decrease plasma concentrations of baloxavir, which may reduce XOFLUZA efficacy. 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).

 

Vaccines: 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.


For additional important safety information, please see the XOFLUZA full Prescribing Information.

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.