For Patients and Caregivers

Effective Treatment for the Flu in Patients as Young as 5 Years1

Otherwise Healthy Patients ≥12 Years

33% Faster (1.1 Days) Flu Symptom Relief With XOFLUZA vs Placebo1

42%

FASTER FLU
SYMPTOM RELIEF

PATIENT SUBGROUP

Patients 12 to 17 years old had 42% faster (1.6 days) flu symptom relief with XOFLUZA vs placebo1

  • The XOFLUZA group (n=63) had a median time of 54 hours (95% CI, 43, 81) to symptom alleviation vs 93 hours (95% CI, 64, 118) for placebo (n=27)

In Trial T083l (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% Cl: 50, 59) vs 80 hours (95% Cl: 73, 87) with placebo. 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

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

XOFLUZA is the only approved single-dose oral antiviral to demonstrate improvement in flu symptoms over placebo in patients 12 years and older at high risk of developing flu complications.1

High-Risk Patients ≥12 Years

28% Faster (1.3 days) Improvement of Flu Symptoms With XOFLUZA vs Placebo1

In Trial T0832, subjects aged ≥12 years in the efficacy analysis (N=1158/2182) received XOFLUZA 40 mg or 80 mg according to body weight (n=385), placebo (n=385), or oseltamivir 75 mg twice daily for 5 days (n=388). High-risk factors were based on the Centers for Disease Control and Prevention (CDC) definition of health factors known to increase the risk of developing serious complications from influenza, including underlying asthma or chronic lung disease, diabetes, heart disease, morbid obesity, or ≥65 years of age. The primary efficacy endpoint was time to improvement of influenza symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue). This endpoint included alleviation of new symptoms and improvement of any preexisting symptoms that had worsened due to influenza. The median value of the primary endpoint of time to improvement of symptoms (TTIS) with XOFLUZA was 73 hours (95% CI: 67, 85) vs 102 hours (95% CI: 93, 113) with placebo.1 

Other high-risk factors for inclusion in Trial T0832 were Native American or Alaskan Native ancestry, residents of long-term care facilities, neurological/neurodevelopmental conditions, women ≤2 weeks postpartum and not breastfeeding, metabolic disorders, such as inherited metabolic disorders and mitochondrial disorders, blood disorders, such as sickle cell disease, and persons with immunosuppression.1,5,6

There was no statistically significant difference in the median time to improvement of influenza symptoms in the subjects who received XOFLUZA (73 hours) and those who received oseltamivir (81 hours).1

Who is considered high risk for flu complications?7-9

Millions of people in the United States are at high risk for developing flu complications. These risk factors include but are not limited to:

Pediatric Patients 5-11 Years

Flu-Symptom Relief in 5.75 Days With 1 Dose of XOFLUZA vs 10 Doses of Oseltamivir1

*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. This trial was not powered to detect statistically significant differences in this secondary endpoint. 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

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

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XOFLUZA® (baloxavir marboxil) Virus Icon

Act After Exposure

Patients can reduce their risk of contracting the flu after exposure to an infected household member by taking single-dose XOFLUZA.1

Post-exposure prophylaxis efficacy >
XOFLUZA® (baloxavir marboxil) Safety Icon

Safety Profile

Single-dose XOFLUZA has a generally well-tolerated safety profile.1,2

See safety profile >

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.

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