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
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