For Patients and Caregivers

The Only Single-Dose
Oral Antiviral for the Flu1

Treat the Flu With One Dose of XOFLUZA
vs 10 Doses of Oseltamivir1

Treat the flu without 5-day dosing1,2

Help prevent the flu after exposure without 10-day dosing1,2

Single-dose XOFLUZA should be taken as soon as possible and within 48 hours of flu symptom onset for treatment or following contact with a patient who has the flu.1

Single-Dose XOFLUZA Is Available as One 40-mg or 80-mg Tablet1

 Dosing recommendations for XOFLUZA tablets

A full course of flu treatment in one tablet for patients aged ≥5 years:

Patient Body Weight (kg) Recommended Single Oral Dose (Tablets)
20 kg to less than 80 kg One 40-mg tablet
At least 80 kg One 80-mg tablet

Single-dose XOFLUZA can be taken with or without food. It should not be taken with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (eg, calcium, zinc, iron, magnesium, or selenium).1


Oral suspension is not available for commercial market.

Icon of a sample. Order a Sample of Single-Dose XOFLUZA
Order a Sample of Single-Dose XOFLUZA

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

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for XOFLUZA.
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Frequently
asked
questions

XOFLUZA is taken orally as a single dose and may be taken with or without food.1

It should not be taken with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (eg, calcium, iron, magnesium, selenium, or zinc) because these may reduce baloxavir exposure.1

Potential candidates include patients 5 years of age and older with acute uncomplicated influenza whose symptoms began within the 48-hour treatment window, including otherwise healthy patients and patients at high risk of influenza-related complications.1 It is also indicated for post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.

Treatment decisions should consider clinical presentation, timing from symptom onset, influenza activity, patient-specific risk factors, and current CDC or local public health guidance. XOFLUZA is not a substitute for annual influenza vaccination.

Please refer to the XOFLUZA Prescribing Information for the most current FDA-approved indications.

Yes. In the US, XOFLUZA is indicated for post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.1

Post-exposure prophylaxis decisions should consider exposure history, timing, patient-specific risk factors, and current CDC or local public health guidance. Xofluza is not a substitute for annual influenza vaccination.

For treatment, XOFLUZA should be initiated as soon as possible and within 48 hours of influenza symptom onset, per the US label.1

Patients should be managed according to current clinical guidelines and institutional protocols.

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.

    • TAMIFLU. Prescribing information. Genentech, Inc.

      TAMIFLU. Prescribing information. Genentech, Inc.

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