For Patients and Caregivers

Help Prevent the Flu After Exposure1

XOFLUZA is the first and only single-dose post-exposure prophylaxis medication for influenza (patients aged ≥5 years)1

 

In patients (aged ≥5 years) who were given single-dose XOFLUZA, their risk of contracting the flu after contact with an infected household member was reduced by 87% compared with patients who received placebo (2% XOFLUZA [95% CI: 1%, 4%] vs 13% placebo [95% CI: 10%, 17%]), corresponding to an estimated adjusted risk ratio of 0.15 (P<0.0001), based on randomization factors.1,14

 

XOFLUZA® (baloxavir marboxil) Efficacy for Post-Exposure Flu Prophylaxis

Trial T0834 was a phase 3, randomized, double-blind, multicenter, placebo-controlled study designed to evaluate the efficacy of a single oral dose of XOFLUZA compared with placebo in the prevention of influenza in subjects who were household contacts of influenza-infected patients in Japan. Influenza-infected index patients were required to have onset of symptoms for ≤48 hours, and subjects (household contacts) were required to have lived with the influenza-infected index patient for ≥48 hours. A total of 715 subjects (XOFLUZA n=360, placebo n=355) aged 5 years and older were randomized and received a single oral dose of XOFLUZA according to body weight and age, or placebo, on Day 1. Subjects received a single dose of 40 mg or 80 mg of XOFLUZA according to body weight (20 kg to <80 kg or ≥80 kg, respectively). The primary efficacy endpoint was the proportion of household subjects who were infected with influenza virus and presented with fever and at least one respiratory symptom from Day 1 to Day 10. Influenza infection was confirmed by RT-PCR, fever was defined as a body temperature (axillary) ≥37.5°C, and respiratory symptoms were defined as having a symptom of “cough” or “nasal discharge/nasal congestion” with a severity of moderate or severe as assessed by the subject. In subjects that were 5 years of age and older, there was a statistically significant reduction in the proportion of household contacts (subjects) with laboratory-confirmed clinical influenza from 13% in the placebo group to 2% in the XOFLUZA group.1

RT-PCR= reverse transcription polymerase chain reaction.

 

XOFLUZA may be prescribed to patients 5 years and older who have been exposed to the flu, including patients aged ≥12 years at high risk for developing flu-related complications.1

 

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

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Treat With a Single Dose

Keep it simple with a full course of treatment in a single dose.1

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The Burden of the Flu

Most people who get the flu recover in 3 to 14 days, but this isn't the case for all patient types.5,13

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Important Safety Information & Indication

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.