Baloxavir marboxil - Revision history

Ostermayer: /* Comments */

2026-01-14T12:51:58Z

Comments

← Older revision		Revision as of 12:51, 14 January 2026
Line 74:		Line 74:

	==Comments==		==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.<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>		*''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>		*'''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==

Ostermayer: /* Comments */

2026-01-14T12:51:39Z

Comments

← Older revision		Revision as of 12:51, 14 January 2026
Line 75:		Line 75:
	==Comments==		==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.<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>		''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==

Colm at 16:40, 13 January 2026

2026-01-13T16:40:48Z

← Older revision		Revision as of 16:40, 13 January 2026
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	==Administration==		==Administration==
	*Type: [[Antiviral]]		*Type: [[Antiviral]]
	*Dosage Forms: 20 mg, 40 mg tab		*Dosage Forms:
			**20 mg, 40 mg tab
			**reconstituted solution 2 mg/mL
			**30 mg, 40 mg packets for reconstitution
	*Routes of Administration: PO		*Routes of Administration: PO
	*Common Trade Names: Xofluza		*Common Trade Names: Xofluza
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	==Pediatric Dosing==		==Pediatric Dosing==
	*Approved for ~~use~~ in ~~pediatric~~ patients 12 and older		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.
	* ~~40-79.9~~ kg: 40 mg PO x1		*Oral bottle suspension:
	**~~Start within 48 hours of symptom onset~~		**Less than 20kg: 2mg/kg PO x1
	**~~Avoid co-administration with dairy products, calcium supplements~~		**20kg to <80kg: 40 mg (20 mL)
	*>80 mg: 80 mg PO x1		**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		**Start within 48 hours of symptom onset
	**Avoid co-administration with dairy products, calcium supplements		**Avoid co-administration with dairy products, calcium supplements
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	==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>

	==See Also==		==See Also==

Ihearttroponin at 14:49, 18 March 2020

2020-03-18T14:49:05Z

← Older revision		Revision as of 14:49, 18 March 2020
Line 68:		Line 68:
	*[[Influenza]]		*[[Influenza]]
	*[[Antiviral]]		*[[Antiviral]]
	*[[Tamiflu]]		*[[Tamiflu]]/[[Oseltamivir]]

	==References==		==References==

Ihearttroponin at 14:48, 18 March 2020

2020-03-18T14:48:18Z

← Older revision		Revision as of 14:48, 18 March 2020
Line 1:		Line 1:
	==Administration==		==Administration==
	*Type:		*Type: [[Antiviral]]
	*Dosage Forms:		*Dosage Forms: 20 mg, 40 mg tab
	*Routes of Administration:		*Routes of Administration: PO
	*Common Trade Names:		*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==
			*Approved for use in pediatric patients 12 and older
			* 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

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

	==References==		==References==

Rossdonaldson1: Created page with "==Administration== Type: Dosage Forms: Routes of Administration: Common Trade Names: ==Adult Dosing== ==Pediatric Dosing== ==Special Populations== ===Drug pregnan..."

2020-03-10T21:38:49Z

Created page with "==Administration== *Type: *Dosage Forms: *Routes of Administration: *Common Trade Names: ==Adult Dosing== ==Pediatric Dosing== ==Special Populations== ===Drug pregnan..."

New page

==Administration==
*Type:
*Dosage Forms:
*Routes of Administration:
*Common Trade Names:

==Adult Dosing==

==Pediatric Dosing==

==Special Populations==
===[[Drug pregnancy categories|Pregnancy Rating]]===
*

===Lactation risk===
*

===Renal Dosing===
*Adult:
*Pediatric:

===Hepatic Dosing===
*Adult:
*Pediatric:

==Contraindications==
*Allergy to class/drug

==Adverse Reactions==
===Serious===

===Common===

==Pharmacology==
*Half-life:
*Metabolism:
*Excretion:

==Mechanism of Action==

==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>

==See Also==

==References==
<references/>

[[Category:Pharmacology]]

Baloxavir marboxil - Revision history

Ostermayer: /* Comments */

Ostermayer: /* Comments */

Colm at 16:40, 13 January 2026

Ihearttroponin at 14:49, 18 March 2020

Ihearttroponin at 14:48, 18 March 2020

Rossdonaldson1: Created page with "==Administration== *Type: *Dosage Forms: *Routes of Administration: *Common Trade Names: ==Adult Dosing== ==Pediatric Dosing== ==Special Populations== ===Drug pregnan..."

Rossdonaldson1: Created page with "==Administration== Type: Dosage Forms: Routes of Administration: Common Trade Names: ==Adult Dosing== ==Pediatric Dosing== ==Special Populations== ===Drug pregnan..."