In recognition of National Influenza Vaccination Week (NIVW), our latest edition of the Guidelines+ Monographs Series will delve into the medication baloxavir marboxil, marketed under the brand name Xofluza® by Genentech. Xofluza is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for the 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 and post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. It was initially approved in 2018.
In the following sections, we will provide a comprehensive overview of baloxavir marboxil and analyze its positioning across various guidelines for its approved indications.
Note* – This Guidelines+ Monographs for baloxavir marboxil (Xofluza) is current as of December 2024. Consult our clinical guidelines library and/or or medication information look up tool to ensure you are always accessing the most current information.
Without further delay, let’s jump in!
Medication Overview
- Brand name: Xofluza
- Generic name: baloxavir marboxil
- Manufacturer(s): Genentech
- Initial FDA Approval: October 2018
Indications and FDA Approval Details
| Indicated Condition | Indicated | Age Range | Date Approved |
|---|---|---|---|
| Influenza | for the treatment of Influenza in Children Aged Five and Older and to prevent influenza in children aged five and older following contact with an infected person. | 5 years of age and older | August 11, 2022 |
| Influenza | as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). | 12 years of age and older | November 23, 2020 |
| Influenza | for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications. | 12 years of age and older | October 17, 2019 |
| Influenza | for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours. | 12 years of age and older | October 24, 2018 |
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.
Dosage and Administration
Treatment and Post-Exposure Prophylaxis of Influenza
XOFLUZA should be taken as a single dose as soon as possible and within 48 hours of influenza symptom onset for treatment of acute uncomplicated influenza or following contact with an individual who has influenza. XOFLUZA may be taken with or without food.
| Patient Body Weight (kg) | Recommended Single Oral Dose in Patients 5 Years of Age and Older (Tablets) |
|---|---|
| 20 kg to less than 80 kg | One 40 mg tablet(blister card contains one 40 mg tablet) |
| At least 80 kg | One 80 mg tablet(blister card contains one 80 mg tablet) |
| Patient Body Weight (kg) | Recommended Single Oral Dose in Patients 5 Years of Age and Older (For Oral Suspension) |
|---|---|
| Less than 20 kg | 2 mg/kg taken as a single dose |
| 20 kg to less than 80 kg | 40 mg (20 mL) taken as a single dose |
| At least 80 kg | 80 mg (40 mL) taken as a single dose |
Refer to the Full Prescribing Information for additional information on the recommended dosage and preparation of XOFLUZA for oral suspension for oral or enteral use in patients 5 years of age and older.
Dosage Forms and Strengths
- Tablets: 40 mg and 80 mg.
- For oral suspension: 40 mg/20 mL when constituted for final concentration of 2 mg/mL.
Contraindications
XOFLUZA is contraindicated in patients with a history of hypersensitivity to baloxavir marboxil or any of its ingredients.
Warnings and Precautions
- Hypersensitivity such as anaphylaxis, angioedema, urticaria, and erythema multiforme: Initiate appropriate treatment 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, 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 than older subjects.
- Risk of bacterial infection: 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
Adverse events reported in at least 1% of adult and adolescent influenza subjects treated with XOFLUZA included diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%).
Drug Interactions
- 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).
- Live attenuated influenza vaccines may be affected by antivirals.
Now that we’ve covered the basic monograph information for Xofluza, let’s take a closer look at how it is currently recommended in various clinical practice guidelines.
Specific Inclusions of Baloxavir Marboxil in the Guidelines
- Recommendations for Prevention and Control of Influenza in Children
- Authoring Society: American Academy of Pediatrics (AAP)
- Publication: August 26, 2024
- The AAP Guidelines notes the following: oral baloxavir marboxil is approved by the FDA for treatment of acute uncomplicated influenza within 2 days of illness onset. It is administered orally or by feeding tube. It should not be administered with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (eg, calcium, iron, magnesium, selenium, or zinc). Baloxavir marboxil is not recommended as monotherapy for treatment of influenza in individuals who are severely immunocompromised. It is not recommended for persons who are pregnant, or breastfeeding.
- Clinical Practice Guidelines for Influenza
- Authoring Organization: World Health Organization (WHO)
- Publication: September 12, 2024
- New recommendations for antiviral and antibiotic treatment of patients with non-severe influenza includes a conditional recommendation for the use of baloxavir for patients with nonsevere influenza and at high risk of progression to severe disease.
- New recommendations for prevention amongst persons with exposure to seasonal influenza virus but without infection includes a conditional recommendation for the use of baloxavir for asymptomatic persons at extremely high risk for hospitalization if they were to develop seasonal influenza.
This concludes our Guidelines+ Monographs for baloxavir marboxil (Xofluza). This list is current as of December 2024 and may be updated over time as new indications are approved and/or new guidelines published or updated. Sign up for alerts and stay informed on the latest published guidelines and articles.
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