Recognize and Treat the Flu Promptly With an Antiviral*

There are serious risks associated with the flu5,13

Most patients who get the flu recover in 3 to 14 days, but influenza can cause complications that could be life threatening. For high-risk patients, dangers of the flu are even greater and can lead to serious complications, make chronic health problems worse, or even cause death.5,13

During the 2021 to 2022 flu season in the United States, the CDC estimated that influenza was associated with up to15:

13,000,000
FLU ILLNESSES

170,000
HOSPITALIZATIONS

14,000
DEATHS

 


Flu vaccines are widely available and play an essential role in flu prevention. However, they are not always used or may not always be effective, leaving people at risk.10

 

Treat the flu immediately

XOFLUZA® (baloxavir marboxil) Serious Disease Icon

The flu is a serious, contagious disease that impacts people of all ages and ethnicities. To make matters more serious, some symptoms of the flu can be quite similar to and/or overlap with the typical symptoms of COVID-19.13,16-23

SYMPTOMS FLU COVID-19 COMMON COLD
Incubation Period 1-4 days Varies 2-4 days
Symptom Onset Sudden Gradual or Sudden Gradual
Fever Common Common Rare
Chills Common Common Rare
Cough Common Common Mild to Moderate
Fatigue Common Common Sometimes
Runny Nose Common Sometimes Common
Nasal Congestion/Stuffy Nose Common Sometimes Common
New Loss of Taste/Sense of Smell Not
Reported/
Rare
Common Not Reported/Rare
Diarrhea Sometimes Sometimes Rare
Body Aches Common Sometimes Mild
Sore Throat Sometimes Sometimes Common
Headache Common Sometimes Rare
Shortness of Breath Sometimes Common Mild

While single-dose XOFLUZA does not treat COVID-19 or the common cold, coinfection with the flu and COVID-19 is possible. If the flu is confirmed or suspected, consider prescribing a flu antiviral immediately, regardless of COVID-19 infection.1,16,17


Influenza antivirals have been shown to shorten the duration of flu symptoms.24

The CDC Recommends Treating the Flu Empirically With an Antiviral24

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. The CDC updates its Antiviral and Treatment Recommendations every year and has included XOFLUZA among its list of antiviral medications recommended for the flu.24‡


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

 

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.

 

Indication

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

  • Treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours and who are:
    • otherwise healthy adults and pediatric patients 5 years of age and older, OR
    • adults and pediatric patients 12 years of age and older who are at high risk of developing influenza-related complications
  • Post-exposure prophylaxis (PEP) 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.

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.
 

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, the 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 (43%, 36/83) than in pediatric subjects ≥5 years to <12 years of age (16%, 19/117) or subjects ≥12 years of age (7%, 60/842). The potential for transmission of resistant strains in the community has not been determined.
 

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 adult and adolescent patients (≥12 years of age) in clinical studies for acute uncomplicated influenza were diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%).
  • The most frequently reported adverse reactions (≥5%) in pediatric patients (5 to <12 years of age) in clinical studies for acute uncomplicated influenza were vomiting (5%) and diarrhea (5%).
  • The safety profile reported in a clinical study for post-exposure prophylaxis was similar in pediatric patients ages 5 to <12 years old as that reported in adults and adolescents 12 years of age and older.

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.