XOFLUZA: Effective Treatment for the Flu1

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 in the efficacy analysis received either XOFLUZA (n=455), placebo (n=230), or oseltamivir (n=377). Subjects aged ≥12 years received weight-based XOFLUZA or placebo as a single oral dose. For subjects aged ≥12 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
 


In Trial T0831, there was no difference in the time to alleviation of symptoms between subjects (age ≥20 years) who received XOFLUZA (54 hours) and those who received oseltamivir (54 hours).1

Patients aged 5 to <12 years had flu symptom relief in 5.75 days1

XOFLUZA® (baloxavir marboxil) Trial CP40563

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

 

In Trial CP40563, 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). Subjects at high risk of developing complications associated with influenza were included in the trial (16% [19/118]). The secondary efficacy endpoint included time to alleviation of influenza signs and symptoms (TTASS) of a single one-time dose of XOFLUZA compared with 5 days of oseltamivir administered twice daily. TTASS 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 oseltamivir (126 hours [95% CI: 96, 166]).1

Single-dose XOFLUZA tablet size

XOFLUZA 40-mg tablet is only 11 mm in length or .43 inches.

XOFLUZA 80-mg tablet is only 16 mm in length or .63 inches.

 

XOFLUZA® (baloxavir marboxil) Tablet Size
 XOFLUZA® (baloxavir marboxil) Sample Icon

Order a Sample of Single-Dose XOFLUZA

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

XOFLUZA® (baloxavir marboxil) Single Dose Icon

Treat With a Single Dose

XOFLUZA is the first and only single-dose oral antiviral for the flu.1

XOFLUZA® (baloxavir marboxil) Safety Icon

Safety Profile

View single-dose XOFLUZA safety data results from clinical trials.1,2

Important Safety Information & Indication

Indication

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 (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 (40%, 38/96) 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.

    • XOFLUZA. Prescribing information. Genentech USA, Inc.

      XOFLUZA. Prescribing information. Genentech USA, Inc.

    • Baker J, Block SL, Matharu B, et al. Baloxavir marboxil single-dose treatment in influenza-infected children: a randomized, double-blind, active controlled phase 3 safety and efficacy trial (miniSTONE-2). Pediatr Infect Dis J. 2020;39(8):700-705. doi:10.1097/INF.0000000000002747

      Baker J, Block SL, Matharu B, et al. Baloxavir marboxil single-dose treatment in influenza-infected children: a randomized, double-blind, active controlled phase 3 safety and efficacy trial (miniSTONE-2). Pediatr Infect Dis J. 2020;39(8):700-705. doi:10.1097/INF.0000000000002747

    • TAMIFLU. Prescribing information. Genentech USA, Inc.; 2019.

      TAMIFLU. Prescribing information. Genentech USA, Inc.; 2019.

    • Hayden FG, Sugaya N, Hirotsu N, et al; Baloxavir Marboxil Investigators Group. Baloxavir marboxil for uncomplicated influenza in adults and adolescents. N Engl J Med. 2018;379(10):913-923.

      Hayden FG, Sugaya N, Hirotsu N, et al; Baloxavir Marboxil Investigators Group. Baloxavir marboxil for uncomplicated influenza in adults and adolescents. N Engl J Med. 2018;379(10):913-923.

    • Ison MG, Portsmouth S, Yoshida Y, et al. Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2020;20(10):1204-1214. doi:10.1016/S1473-3099(20)30004-9

      Ison MG, Portsmouth S, Yoshida Y, et al. Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2020;20(10):1204-1214. doi:10.1016/S1473-3099(20)30004-9

    • Ison MG, Portsmouth S, Yoshida Y, et al. Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2020;20(10)(suppl):1-63. doi:10.1016/S1473-3099(20)30004-9

      Ison MG, Portsmouth S, Yoshida Y, et al. Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2020;20(10)(suppl):1-63. doi:10.1016/S1473-3099(20)30004-9

    • People at Increased Risk for Flu Complications. Centers for Disease Control and Prevention (CDC). Accessed January 30, 2025. https://www.cdc.gov/flu/highrisk/index.htm

      People at Increased Risk for Flu Complications. Centers for Disease Control and Prevention (CDC). Accessed January 30, 2025. https://www.cdc.gov/flu/highrisk/index.htm

    • National Diabetes Statistics Report. CDC. Accessed January 30, 2025. https://www.cdc.gov/diabetes/php/data-research/index.html

      National Diabetes Statistics Report. CDC. Accessed January 30, 2025. https://www.cdc.gov/diabetes/php/data-research/index.html

    • Most recent national asthma data. CDC. Accessed August 6, 2024. https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm

      Most recent national asthma data. CDC. Accessed August 6, 2024. https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm

    • About COPD. CDC. Accessed January 30, 2025. https://www.cdc.gov/copd/about/index.html

      About COPD. CDC. Accessed January 30, 2025. https://www.cdc.gov/copd/about/index.html

    • Heart disease. CDC. Accessed January 30, 2025. https://www.cdc.gov/nchs/fastats/heart-disease.htm

      Heart disease. CDC. Accessed January 30, 2025. https://www.cdc.gov/nchs/fastats/heart-disease.htm

    • Clinical signs and symptoms of influenza. CDC. Accessed January 30, 2025. https://www.cdc.gov/flu/hcp/clinical-signs/index.html

      Clinical signs and symptoms of influenza. CDC. Accessed January 30, 2025. https://www.cdc.gov/flu/hcp/clinical-signs/index.html

    • Ikematsu H, Hayden FG, Kawaguchi K, et al. Baloxavir marboxil for prophylaxis against influenza in household contacts. N Engl J Med. 2020;383(4):309-320. doi:10.1056/NEJMoa1915341

      Ikematsu H, Hayden FG, Kawaguchi K, et al. Baloxavir marboxil for prophylaxis against influenza in household contacts. N Engl J Med. 2020;383(4):309-320. doi:10.1056/NEJMoa1915341

    • 2023-2024 U.S. flu season: Preliminary in-season burden estimates. CDC. Accessed January 30, 2025. https://www.cdc.gov/flu-burden/php/data-vis/2023-2024.html

      2023-2024 U.S. flu season: Preliminary in-season burden estimates. CDC. Accessed January 30, 2025. https://www.cdc.gov/flu-burden/php/data-vis/2023-2024.html

    • 2023-2024 Flu Season. Accessed January 30 2025. https://www.cdc.gov/flu/season/2023-2024.html

      2023-2024 Flu Season. Accessed January 30 2025. https://www.cdc.gov/flu/season/2023-2024.html

    • Symptoms of COVID-19. CDC. Updated June 25, 2024. Accessed August 7, 2024. https://www.cdc.gov/covid/signs-symptoms/

      Symptoms of COVID-19. CDC. Updated June 25, 2024. Accessed August 7, 2024. https://www.cdc.gov/covid/signs-symptoms/

    • Allan GM, Arroll B. Prevention and treatment of the common cold: making sense of the evidence. CMAJ. 2014;186(3):190-199. doi:10.1503/cmaj.121442

      Allan GM, Arroll B. Prevention and treatment of the common cold: making sense of the evidence. CMAJ. 2014;186(3):190-199. doi:10.1503/cmaj.121442

    • Cold versus flu. CDC. Accessed January 30, 2025. https://www.cdc.gov/flu/symptoms/coldflu.htm

      Cold versus flu. CDC. Accessed January 30, 2025. https://www.cdc.gov/flu/symptoms/coldflu.htm

    • Is it flu, COVID-19, allergies or a cold? National Institutes of Health. https://newsinhealth.nih.gov/2022/01/it-flu-covid-19-allergies-or-cold. Accessed August 7, 2024.

      Is it flu, COVID-19, allergies or a cold? National Institutes of Health. https://newsinhealth.nih.gov/2022/01/it-flu-covid-19-allergies-or-cold. Accessed August 7, 2024.

    • About adenovirus. Symptoms. CDC. https://www.cdc.gov/adenovirus/about/index.html. Accessed August 7, 2024.

      About adenovirus. Symptoms. CDC. https://www.cdc.gov/adenovirus/about/index.html. Accessed August 7, 2024.

    • Is it a cold, the flu, or COVID-19? National Institute on Aging. https://www.nia.nih.gov/health/covid-19/it-cold-flu-or-covid-19. Accessed January 30, 2025.

      Is it a cold, the flu, or COVID-19? National Institute on Aging. https://www.nia.nih.gov/health/covid-19/it-cold-flu-or-covid-19. Accessed January 30, 2025.

    • COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Updated February 29, 2024. Accessed January 30, 2025. https://www.ncbi.nlm.nih.gov/books/NBK570371/pdf/Bookshelf_NBK570371.pdf

      COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Updated February 29, 2024. Accessed January 30, 2025. https://www.ncbi.nlm.nih.gov/books/NBK570371/pdf/Bookshelf_NBK570371.pdf

    • Influenza antiviral medications: summary for clinicians. CDC. Accessed July 24, 2024. https://www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm#Table1

      Influenza antiviral medications: summary for clinicians. CDC. Accessed July 24, 2024. https://www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm#Table1

    • Samji T. Influenza A: understanding the viral life cycle. Yale J Biol Med. 2009;82(4):153-159.

      Samji T. Influenza A: understanding the viral life cycle. Yale J Biol Med. 2009;82(4):153-159.

    • De Clercq E, Li G. Approved antiviral drugs over the past 50 years. Clin Microbiol Rev. 2016;29(3):695-747.

      De Clercq E, Li G. Approved antiviral drugs over the past 50 years. Clin Microbiol Rev. 2016;29(3):695-747.

    • Fiore AE, Fry A, Shay D, et al. Antiviral agents for the treatment and chemoprophylaxis of influenza—recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011;60(1):1-24.

      Fiore AE, Fry A, Shay D, et al. Antiviral agents for the treatment and chemoprophylaxis of influenza—recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011;60(1):1-24.

    • von Itzstein M. The war against influenza: discovery and development of sialidase inhibitors. Nat Rev Drug Discov. 2007;6(12):967-974. doi:10.1038/nrd2400

      von Itzstein M. The war against influenza: discovery and development of sialidase inhibitors. Nat Rev Drug Discov. 2007;6(12):967-974. doi:10.1038/nrd2400