Effective Treatment for the Flu

Otherwise healthy patients aged ≥12 years had flu symptom relief in just 2.3 days1

XOFLUZA® (baloxavir marboxil) Flu Symptom Alleviation for Otherwise Healthy Patients in Clinical Trial

33% (1.1 days) faster alleviation of flu symptoms (in patients aged ≥12 years) with single-dose XOFLUZA compared with placebo.1

In Trial T0831 (conducted in the United States and Japan), subjects aged 20 to 64 years received either XOFLUZA (n=612), oseltamivir (n=514), or placebo (n=310). Adolescent subjects 12 to less than 20 years of age received weight-based XOFLUZA or placebo as a single oral dose. For subjects aged 12 to 64 years, the median value of the primary endpoint of time to alleviation of symptoms (TTAS) with XOFLUZA was 54 hours (95% CI: 50, 59) vs 80 hours (95% CI: 73, 87) with placebo.1

TTAS was defined as the time when all 7 symptoms (cough, sore throat, nasal congestion, headache, feverishness, myalgia, and fatigue) had been assessed by the subject as none or mild for a duration of at least 21.5 hours.1,4

 


42% (1.6 days) faster relief from flu symptoms (in patients aged 12 to 17 years) with single-dose XOFLUZA compared with placebo.1

For subjects aged 12 to 17 years in Trial T0831, TTAS was achieved 39 hours (1.6 days) faster with XOFLUZA (n=63) when compared with placebo (n=27; median time of 54 hours [95% CI: 43, 81] vs 93 hours [95% CI: 64, 118]).1

Otherwise healthy patients aged 5 to <12 years had flu symptom relief in 5.75 days

XOFLUZA® (baloxavir marboxil) Trial CP40563

Trial CP40563 was not powered to detect statistically significant differences in this secondary endpoint.

 

In Trial CP40563, otherwise healthy pediatric subjects aged 5 to <12 years (n=118) were randomized (2:1) and received a single one-time oral dose of XOFLUZA (n=79) based on body weight (2 mg/kg for subjects weighing <20 kg or 40 mg for subjects weighing ≥20 kg) or oseltamivir (n=39) for 5 days (dose based on body weight). The secondary efficacy endpoint included time to alleviation of influenza signs and symptoms (TTASS) of a single one-time dose of XOFLUZA with 5 days of oseltamivir administered twice daily. TTAS was defined as the time when all of the following were met for at least 21.5 hours: cough and nasal symptoms were assessed by the caregiver as no problem or minor problem, subject was able to return to normal daily activity, and subject was afebrile (temperature ≤37.2°C). TTASS was comparable between XOFLUZA (138 hours [95% CI: 117, 163]) and olseltamivir (126 hours [95% CI: 96, 156]).1

Single-dose XOFLUZA tablet size

XOFLUZA® (baloxavir marboxil) Tablet Size
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Order a Sample of Single-Dose XOFLUZA

Sample a full course of flu treatment with single-dose XOFLUZA.1

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.