For Patients and Caregivers

TREAT AND HELP PREVENT* THE FLU WITH SINGLE-DOSE XOFLUZA1

XOFLUZA is approved for the treatment and prevention* of the flu in patients as young as 5 years.1

*After exposure.

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TREAT AND HELP PREVENT* THE FLU WITH SINGLE-DOSE XOFLUZA1

XOFLUZA is approved for the treatment and prevention* of the flu in patients as young as 5 years.1

*After exposure.

Patient savings
Help your patients find XOFLUZA

Help your patients fight the flu

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XOFLUZA dosing

Keep it simple with a single dose.1

Single-dose Rx

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Efficacy data

Treats and helps prevent the flu after contact in patients as young as 5 years of age.1

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In patients aged ≥12 years, median times to improvement of symptoms vs placebo were 54 hours vs 80 hours (Trial T0831) and 73 hours vs 102 hours (Trial T0832). In patients aged 5 to <12 years, the median times to alleviation of influenza signs and symptoms were 138 hours in the XOFLUZA arm and 126 hours in the oseltamivir arm (Trial CP40563); proportion of patients aged ≥5 years contracting the flu after exposure vs placebo was 2% vs 13% (Trial T0834).1

XOFLUZA is a single-dose antiviral medication indicated for the treatment of acute uncomplicated influenza (flu) in patients aged 5 years and older who have been symptomatic for no more than 48 hours. It is also indicated for post-exposure prophylaxis of influenza in patients 5 years and older following contact with an individual who has the flu. Over-the-counter medicines just treat symptoms. Prescription XOFLUZA works differently, with only one dose to attack the flu virus at its source.
 

One-dose XOFLUZA is available as a film-coated 40- or 80- mg tablet. The medication is administered as a single, weight-based dose. The recommended dose for patients weighing between 20 - <80 kg (~44 - 176 lbs) is 40 mg, and the recommended dose for patients ≥80 kg (~176 lbs) is 80 mg. Avoid coadministration of XOFLUZA with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (eg, calcium, iron, magnesium, selenium, or zinc).
 

The most common adverse reactions reported in clinical trials include diarrhea, bronchitis, nausea, sinusitis, headache, and vomiting. Cases of anaphylaxis, urticaria, angioedema, and erythema multiforme have been reported.
 

Patient’s out-of-pocket cost will vary by insurance, including their coverage, co-pay, deductible, and out-of-pocket max. XOFLUZA offers two ways to help patients afford treatment: (1) If a patient’s out-of-pocket cost is more than $35, the XOFLUZA coupon can help. Eligible patients may pay as little as $35 for XOFLUZA (up to $70 off). (2) With the XOFLUZA $50 Cash Pay Option, eligible patients pay $50 if choosing to self-pay at select pharmacies. Terms & conditions apply.
 

XOFLUZA is available with a prescription in-store or online. The XOFLUZA product finder can help you identify pharmacy options that best meet your needs based on your ZIP code, including local pharmacies with likely availability, same-day, and mail delivery options.

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 (eg, 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, Inc.

      XOFLUZA. Prescribing information. Genentech, Inc.

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