Brand Name
Xofluza
Generic Name
Baloxavir Marboxil
View Brand Information FDA approval date: October 24, 2018
Classification: Polymerase Acidic Endonuclease Inhibitor
Form: Tablet, Granule
What is Xofluza (Baloxavir Marboxil)?
XOFLUZA is an influenza virus polymerase acidic endonuclease inhibitor indicated for: Treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours and who are: - otherwise healthy adults and pediatric patients 5 years of age and older, OR - adults and pediatric patients 12 years of age and older who are at high risk of developing influenza-related complications.
Approved To Treat
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Brand Information
Xofluza (BALOXAVIR MARBOXIL)
1CONTRAINDICATIONS
XOFLUZA is contraindicated in patients with a history of hypersensitivity to baloxavir marboxil or any of its ingredients. Serious allergic reactions have included anaphylaxis, angioedema, urticaria, and erythema multiforme
2OVERDOSAGE
Treatment of an overdose of XOFLUZA should consist of general supportive measures, including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with XOFLUZA.
Baloxavir is unlikely to be significantly removed by dialysis due to high serum protein binding
3DESCRIPTION
Baloxavir marboxil is an influenza virus PA endonuclease inhibitor.
The active component of XOFLUZA is baloxavir marboxil. The chemical name of baloxavir marboxil is ({(12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C
Baloxavir marboxil has a molecular mass of 571.55 grams per mole and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol, and practically insoluble in water.
XOFLUZA is supplied as tablets.
XOFLUZA tablets are white to light yellow, film-coated for oral administration
4REFERENCES
- "People at High-Risk for Flu Complications." Refer to U.S. Centers for Disease Control and Prevention "Influenza (Flu)" website.
5HOW SUPPLIED/STORAGE AND HANDLING
XOFLUZA is supplied as tablets (80 mg). The single oral dose to be administered depends on body weight
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
7PRINCIPAL DISPLAY PANEL
