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Xofluza Generic Name & Formulations
Legal Class
Rx
General Description
Baloxavir marboxil 40mg, 80mg; tabs.
Pharmacological Class
Polymerase acidic (PA) endonuclease inhibitor.
How Supplied
Tabs—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Baloxavir marboxil gets converted to its active form baloxavir, which inhibits the endonuclease activity of the polymerase acidic protein, resulting in inhibition of influenza virus replication.
Xofluza Indications
Indications
Treatment of acute uncomplicated influenza in patients ≥5yrs of age who have been symptomatic for no more than 48hrs and who are otherwise healthy or at high risk of developing influenza-related complications. Post-exposure prophylaxis of influenza in individuals ≥5yrs of age following contact with an individual who has influenza.
Limitations of Use
Consider available information on drug susceptibility patterns for circulating influenza strains when deciding whether to use.
Xofluza Dosage and Administration
Adults and Children
<5yrs: not established. ≥5yrs: (20–<80kg): 40mg as a single dose; (≥80kg): 80mg as a single dose.
Xofluza Contraindications
Not Applicable
Xofluza Boxed Warnings
Not Applicable
Xofluza Warnings/Precautions
Warnings/Precautions
Increased risk of treatment-emergent resistance in patients <5yrs of age. Potential secondary bacterial infections; treat appropriately. Pregnancy. Nursing mothers.
Xofluza Pharmacokinetics
Absorption
Time to maximum concentration: 4 hours.
Distribution
Volume of distribution: 1180 L. 92.9–93.9% serum protein bound.
Elimination
Fecal (80.1%), renal (14.7%). Half-life: 79.1 hours. Clearance 10.3 L/hr.
Xofluza Interactions
Interactions
Avoid coadministration with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (eg, calcium, iron, magnesium, selenium, or zinc). May reduce efficacy of live attenuated influenza vaccines.
Xofluza Adverse Reactions
Adverse Reactions
Diarrhea, bronchitis, nausea, sinusitis, headache, vomiting; hypersensitivity reactions.
Xofluza Clinical Trials
See Literature
Xofluza Note
Not Applicable
Xofluza Patient Counseling
See Literature
