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Side Effect Reporting

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.


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Indication

XOFLUZATM is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for:

  • Treatment of acute uncomplicated influenza in patients 12 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 12 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.

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.

Important Safety Information

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.
  • 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 clinical studies for acute uncomplicated influenza were diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%).
  • The most common adverse reaction in a clinical study for post-exposure prophylaxis (PEP) was nasopharyngitis (6%).

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.