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.

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Related Clinical Trials

A Phase IIIb Multicenter, Single-Arm, Open-Label Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Patients With Influenza and Transmission of Influenza to Household Contacts

Summary: This study consists of two parts: Part A Surveillance and Part B Transmission. The main purpose of Part A is to evaluate the prevalence of pre-dose and treatment-emergent amino acid substitutions in pediatric participants' susceptibility \<12 years with influenza treated with baloxavir marboxil. Part B will include a subset of Part A participants who have household contacts (HHCs) recruited to the...

Efficacy of Combination Baloxovir and Oseltamivir Therapy in Influenza Infected Immunocompromised Hosts

Summary: This phase II trial studies the effect of baloxavir in combination with oseltamivir in treating severe influenza infection in patients who have previously received a hematopoietic (blood) stem cell transplant or have a hematological malignancy. Baloxavir is an antiviral drug that inhibits the growth of influenza virus, reduces viral load and prevents further influenza infection. Osetamivir is an a...

A Swiss Multi-center, Randomized, Placebo-controlled Trial on the Efficacy of Baloxavir Marboxil to Reduce Time to Clinical Improvement in Adult Patients Hospitalized for Influenza

Summary: The purpose of this clinical trial is to find out if the medication called baloxavir marboxil (sold under the brand name Xofluza®) can help to reduce the time needed to recover from flu when patients need an hospitalization. Patients infected by influenza and requiring a hospitalization will be approched to be included in the study. The main questions are: 1. When someone is hospitalized with a se...

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
Chemical Structure
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
  1. "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).