Hospital Pharmacy - June 2019 - 165

841044
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HPXXXX10.1177/0018578719841044Hospital PharmacyBaker

Formulary Drug Reviews
Hospital Pharmacy
2019, Vol. 54(3) 165-169
© The Author(s) 2019
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https://doi.org/10.1177/0018578719841044
DOI: 10.1177/0018578719841044
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Baloxavir Marboxil
Danial E. Baker1

Abstract
Each month, subscribers to The Formulary Monograph Service receive 5 well-documented monographs on drugs that are newly
released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers
also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A
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Keywords
Formulary Management/P & T, Infectious Diseases, Drug Information
Generic Name: Baloxavir Marboxil
Proprietary Name: Xofluza (Genentech)
Approval Rating: 1P
Therapeutic Class: Cap-Dependent Endonuclease Protein
Inhibitors
Similar Drugs: Oseltamivir
Sound-/Look-Alike Names: Xolair

Indications
Baloxavir marboxil is approved by the Food and Drug
Administration (FDA) for the treatment of acute, uncomplicated influenza in patients 12 years of age and older who
have been symptomatic for no more than 48 hours.1,2

Clinical Pharmacology
Baloxavir, derived from the prodrug baloxavir marboxil, is a
cap-dependent endonuclease protein inhibitor within the
polymerase acidic protein (PA) subunit of influenza A and B
viruses. It blocks influenza virus replication by inhibiting the
initiation of mRNA synthesis. Baloxavir is effective against
influenza type A and B viruses, including oseltamivirresistant strains and avian strains (H7N9, H5N1).2-7

Pharmacokinetics
Baloxavir marboxil is metabolized to the active form (baloxavir acid).7,8 Median time to peak plasma concentration
(Cmax) is 4 hours.2,7 Administration with food decreases

systematic exposure to baloxavir (48% decrease in Cmax and
36% decrease in area under the curve [AUC]).2
Cmax and AUC increase in a dose-proportional manner
(dose range, 6-80 mg), and mean half-life of baloxavir acid is
79.1 hours.2,7,8 Baloxavir acid is highly protein bound (93%94%). The metabolic pathways include UGT1A3 and
CYP3A4. Following a single dose of radiolabeled baloxavir
40 mg in healthy participants, 80% of the drug was recovered
in the feces and 15% in the urine.2
No clinically significant differences were observed based
on age (adolescents vs adults), race/ethnicity, or gender.
Population pharmacokinetic analysis showed no clinically
meaningful effects of renal function on baloxavir pharmacokinetics in patients with creatinine clearance 50 mL/min or
greater; severe renal impairment has not been evaluated.
Moderate hepatic impairment (Child-Pugh class B) did not
result in clinically meaningful changes, and effects of severe
hepatic impairment have not been evaluated. Body weight
significantly affected baloxavir exposure; increased weight
was associated with decreased baloxavir exposures, leading
to weight-based dosing recommendations.2

1

Washington State University, Spokane, USA

Corresponding Author:
Danial E. Baker, Director of Drug Information Center and Professor of
Pharmacotherapy, College of Pharmacy and Pharmaceutical Sciences,
Washington State University, PO Box 1495, Spokane, WA 99210-1495,
USA.
Email: danial.baker@wsu.edu
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