Baloxavir marboxil: Difference between revisions

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==Administration==
==Administration==
*Type:  
*Type: [[Antiviral]]
*Dosage Forms:
*Dosage Forms:
*Routes of Administration:
**20 mg, 40 mg tab
*Common Trade Names:  
**reconstituted solution 2 mg/mL
**30 mg, 40 mg packets for reconstitution
*Routes of Administration: PO
*Common Trade Names: Xofluza
 
==Indications==
* [[Influenza]]


==Adult Dosing==
==Adult Dosing==
 
* 40-79.9 kg: 40 mg PO x1
**Start within 48 hours of symptom onset
**Avoid co-administration with dairy products, calcium supplements
*>80 mg: 80 mg PO x1
**Start within 48 hours of symptom onset
**Avoid co-administration with dairy products, calcium supplements


==Pediatric Dosing==
==Pediatric Dosing==
 
As of 2025, FDA-approved for 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.
*Oral bottle suspension:
**Less than 20kg: 2mg/kg PO x1
**20kg to <80kg: 40 mg (20 mL)
**80kg and up: 80 mg (40 mL)
*Oral packet suspension:
**15kg to <20kg: 30mg oral packet (suspension) PO x1
**20kg to <80kg: 40mg oral packet (suspension) PO x1
**80kg and up: 80 mg (two 40 mg packets) PO x1
*Oral tablet:
**40kg to <80kg: 40 mg PO x1
**80 kg and up: 80 mg PO x1
*Notes:
**Start within 48 hours of symptom onset
**Avoid co-administration with dairy products, calcium supplements


==Special Populations==
==Special Populations==
===[[Drug pregnancy categories|Pregnancy Rating]]===
*[[Pregnancy Category]]: Not assigned (insufficient data)
*
*[[Lactation risk]]: Avoid use while breastfeeding
 
===Lactation risk===
*


===Renal Dosing===
===Renal Dosing===
*Adult:
*Adult and Pediatric:  
*Pediatric:
**CrCl>50: no adjustment
**CrCl<50 or HD/PD: not defined


===Hepatic Dosing===
===Hepatic Dosing===
*Adult:
*Adult and Pediatric:
*Pediatric:
**Child-Pugh Class A or B: no adjustment
**Child-Pugh Class C: not defined


==Contraindications==
==Contraindications==
*Allergy to class/drug
*Allergy to class/drug
*Pregnancy
*Breastfeeding


==Adverse Reactions==
==Adverse Reactions==
===Serious===
===Serious===
 
*[[Anaphylaxis]]
*[[Angioedema]]
*[[Erythema multiforme]]
*[[Urticaria]]


===Common===
===Common===
 
*Nausea (Especially in older patients)


==Pharmacology==
==Pharmacology==
*Half-life:  
*Half-life: 79.1 hours
*Metabolism:  
*Metabolism: liver (CYP450)
*Excretion:  
*Excretion: Feces (predominant), urine<ref>Baloxavir marboxil [monograph]. Epocrates Version. 20.2 [iPhone]. Epocrates, Inc, San Francisco, CA. Available from https://online.epocrates.com/. Accessed March 18, 2020.</ref>


==Mechanism of Action==
==Mechanism of Action==
 
*Inhibits viral polymerase acidic protein endonuclease activity, which inhibits viral replications


==Comments==
==Comments==
''Only approved for patients >12 years old and >40kg in weight, no current safety data exists for pregnancy and breastfeeding.<ref>https://www.cdc.gov/flu/treatment/baloxavir-marboxil.htm</ref> More expensive but one time dosing. Genentech, its creator, states a recent phase III trial has shown it to be effective for prophylaxis but not currently FDA indicated for this.<ref>https://www.gene.com/download/pdf/xofluza_prescribing.pdf</ref>
*''More expensive but one time dosing.  Only approved for patients 5 years old and older, no current safety data exists for pregnancy and breastfeeding.<ref>https://www.cdc.gov/flu/treatment/baloxavir-marboxil.htm</ref> The effect of severe renal or hepatic impairment on baloxavir pharmacokinetics has not been evaluated. <ref>https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210854s023,214410s008lbl.pdf</ref>
*'''The trial reported a 29.1-hour advantage over placebo (73.2h vs 102.3h), but this represents only a 28% relative improvement in a soft endpoint. The more clinically relevant metric, time to return to pre-illness health, showed no significant difference (126.4h vs 149.8h, p=0.46)<ref>Ison MG, Portsmouth S, Yoshida Y, Shishido T, Mitchener M, Tsuchiya K, Uehara T, Hayden FG. Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2020 Oct;20(10):1204-1214. doi: 10.1016/S1473-3099(20)30004-9</ref>'''


==See Also==
==See Also==
 
*[[Influenza]]
*[[Antiviral]]
*[[Tamiflu]]/[[Oseltamivir]]


==References==
==References==

Latest revision as of 12:51, 14 January 2026

Administration

  • Type: Antiviral
  • Dosage Forms:
    • 20 mg, 40 mg tab
    • reconstituted solution 2 mg/mL
    • 30 mg, 40 mg packets for reconstitution
  • Routes of Administration: PO
  • Common Trade Names: Xofluza

Indications

Adult Dosing

  • 40-79.9 kg: 40 mg PO x1
    • Start within 48 hours of symptom onset
    • Avoid co-administration with dairy products, calcium supplements
  • >80 mg: 80 mg PO x1
    • Start within 48 hours of symptom onset
    • Avoid co-administration with dairy products, calcium supplements

Pediatric Dosing

As of 2025, FDA-approved for 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.

  • Oral bottle suspension:
    • Less than 20kg: 2mg/kg PO x1
    • 20kg to <80kg: 40 mg (20 mL)
    • 80kg and up: 80 mg (40 mL)
  • Oral packet suspension:
    • 15kg to <20kg: 30mg oral packet (suspension) PO x1
    • 20kg to <80kg: 40mg oral packet (suspension) PO x1
    • 80kg and up: 80 mg (two 40 mg packets) PO x1
  • Oral tablet:
    • 40kg to <80kg: 40 mg PO x1
    • 80 kg and up: 80 mg PO x1
  • Notes:
    • Start within 48 hours of symptom onset
    • Avoid co-administration with dairy products, calcium supplements

Special Populations

Renal Dosing

  • Adult and Pediatric:
    • CrCl>50: no adjustment
    • CrCl<50 or HD/PD: not defined

Hepatic Dosing

  • Adult and Pediatric:
    • Child-Pugh Class A or B: no adjustment
    • Child-Pugh Class C: not defined

Contraindications

  • Allergy to class/drug
  • Pregnancy
  • Breastfeeding

Adverse Reactions

Serious

Common

  • Nausea (Especially in older patients)

Pharmacology

  • Half-life: 79.1 hours
  • Metabolism: liver (CYP450)
  • Excretion: Feces (predominant), urine[1]

Mechanism of Action

  • Inhibits viral polymerase acidic protein endonuclease activity, which inhibits viral replications

Comments

  • More expensive but one time dosing. Only approved for patients 5 years old and older, no current safety data exists for pregnancy and breastfeeding.[2] The effect of severe renal or hepatic impairment on baloxavir pharmacokinetics has not been evaluated. [3]
  • The trial reported a 29.1-hour advantage over placebo (73.2h vs 102.3h), but this represents only a 28% relative improvement in a soft endpoint. The more clinically relevant metric, time to return to pre-illness health, showed no significant difference (126.4h vs 149.8h, p=0.46)[4]

See Also

References

  1. ↑ Baloxavir marboxil [monograph]. Epocrates Version. 20.2 [iPhone]. Epocrates, Inc, San Francisco, CA. Available from https://online.epocrates.com/. Accessed March 18, 2020.
  2. ↑ https://www.cdc.gov/flu/treatment/baloxavir-marboxil.htm
  3. ↑ https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210854s023,214410s008lbl.pdf
  4. ↑ Ison MG, Portsmouth S, Yoshida Y, Shishido T, Mitchener M, Tsuchiya K, Uehara T, Hayden FG. Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2020 Oct;20(10):1204-1214. doi: 10.1016/S1473-3099(20)30004-9
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