Baloxavir Marboxil
Baloxavir marboxil is an antiviral medication designed to treat influenza A and B virus infections. It is specifically indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have experienced symptoms for 48 hours or less.
A single-dose oral antiviral medication for treating acute influenza infections.
Key facts at a glance
- ATC
- J05AX25
- RxNorm
- 2099995
- Generic
- Baloxavir Marboxil
- Class
- atc-j05
- Brands
- Xofluza
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- tablet, suspension
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 40mg or 80mg as single dose based on body weight
- Maximum
- consult physician
- Frequency
- single dose
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 40mg or 80mg as single dose based on body weight
- Maximum
- consult physician
- Frequency
- single dose
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 40mg or 80mg as single dose based on body weight
- Maximum
- consult physician
- Frequency
- single dose
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid if possible
use only if benefits outweigh potential risks to fetus; avoid unless clearly needed
regular prenatal monitoring recommended
Use with caution and monitor for adverse effects.
pregnancy
second trimesteravoid if possible
use only if benefits outweigh potential risks; pregnant women are at higher risk for influenza complications
regular prenatal monitoring recommended
Use with caution and monitor for adverse effects.
pregnancy
third trimesteravoid if possible
use only if benefits outweigh potential risks; pregnant women at high risk for influenza complications
regular prenatal monitoring recommended
Use with caution and monitor for adverse effects.
lactation
breastfeedinguse with caution
breastfeeding mothers should use baloxavir with caution; discontinue breastfeeding or express and discard breast milk during treatment and for 7 days after dosing
monitor infant for any adverse effects
geriatric
elderly 65 years and olderno adjustment needed
use standard adult dose; elderly patients at higher risk for influenza complications should be treated promptly
monitor for response to treatment and potential adverse effects
Use with caution and monitor for adverse effects.
pediatric_age
adolescents 12 years and olderweight-based dosing required
approved for patients 12 years and older with uncomplicated influenza; single oral dose based on weight
monitor for clinical response
renal_impairment
mild to moderate renal impairmentno adjustment needed
standard dosing for patients with mild to moderate renal impairment
standard monitoring
renal_impairment
severe renal impairmentuse with caution; limited data
use with caution; limited clinical data available for patients with severe renal impairment
monitor renal function closely
Use with caution and monitor for adverse effects.
hepatic_impairment
mild to moderate hepatic impairmentno adjustment needed
standard dosing for patients with mild to moderate hepatic impairment
standard monitoring
hepatic_impairment
severe hepatic impairmentuse with caution; limited data
use with caution; limited clinical data available for patients with severe hepatic impairment
monitor hepatic function closely
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval for treatment of acute uncomplicated influenza
Drug class
Antiviral agent for influenza treatment
Common uses
Therapeutic indications forBaloxavir Marboxil
Mechanism of action
Molecular mechanism of antiviral activity
Treatment of acute uncomplicated influenza A and B virus infections in patients 12 years and older with symptom onset within 48 hours.
Baloxavir marboxil is a cap-dependent endonuclease inhibitor that blocks viral transcription by inhibiting the endonuclease activity essential for influenza virus replication.
Administered as a single oral dose; effectiveness depends on early initiation within 48 hours of symptom onset. Not a substitute for annual flu vaccination. Common side effects may include headache, diarrhea, and nausea.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy