Xofluza FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 12, 2022.
FDA Approved: Yes (First approved October 24, 2018)
Brand name: Xofluza
Generic name: baloxavir marboxil
Dosage form: Tablets and Granules for Oral Suspension
Company: Genentech, Inc.
Treatment for: Influenza, Influenza Prophylaxis
Xofluza (baloxavir marboxil) is a polymerase acidic (PA) endonuclease inhibitor for the treatment and post-exposure prophylaxis of influenza in people 5 years of age and older.
- Xofluza is 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.
- otherwise healthy adults and pediatric patients 5 years of age and older,
- Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.
- Treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours and who are:
- Xofluza is taken as a single dose as soon as possible (within 48 hours) of influenza symptom onset for treatment of acute uncomplicated influenza, or following contact with an individual who has influenza.
- The approved recommended dosage of Xofluza is based on body weight for patients 5 years of age and older:
- Less than 20 kg: 2 mg/kg (granules for oral suspension) taken as a single dose
- 20 kg to less than 80 kg: 40mg (tablet) or 40 mg/20 mL (granules for oral suspension) taken as a single dose
- At least 80 kg: 80 mg (tablet) or 80 mg/40 mL (granules for oral suspension) taken as a single dose
- Xofluza can be taken with or without food. Do not take Xofluza with dairy products, calcium-fortified beverages, laxatives, antacids or oral supplements containing iron, zinc, selenium, calcium or magnesium.
- The most common side effects of Xofluza include diarrhea, bronchitis, nausea, sinusitis, and headache.
Development timeline for Xofluza
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
