Single-Dose XOFLUZA Was as Safe and as Well Tolerated as Placebo 1*

Single-dose XOFLUZA had a similar adverse event (AE) rate as placebo—including in patients at high risk of developing complications from the flu. 1


The below table shows AEs that occurred in at least 1% of patients (aged ≥12 years) receiving either XOFLUZA or placebo in acute uncomplicated influenza in Trials 1-3. 1

*Based on combined data from 3 trials, a total of 1640 subjects received XOFLUZA: 1334 (81%) were adults (18-64 years of age), 209 (13%) were adults 65 years of age or older, and 97 (6%) were adolescents (12-17 years of age). Of these, 1440 subjects received XOFLUZA at the recommended dose. 1

A Safe Antiviral Flu Rx for Post-Exposure Prophylaxis 1

The safety of XOFLUZA in adult and adolescent patients is based on data from one placebo-controlled clinical study in which 374 patients received XOFLUZA, of which 303 were adult and adolescent patients aged ≥12 years: eight patients (3%) were adults 65 years of age or older, and 12 patients (4%) were adolescents 12 to 17 years of age. 1,11

The most frequently reported AEs in the total study population of Trial 4:

No serious treatment-related adverse events were reported. 1,11


Single-dose XOFLUZA helps protect people who’ve been exposed to the flu by reducing their risk of infection. 1


In Trial 4, conducted in Japan, 607 subjects (XOFLUZA n=303, placebo n=304) ≥12 years of age were randomized to receive a single oral dose of XOFLUZA, based on body weight and age, or placebo. In total, 374 subjects were treated with XOFLUZA and 375 with placebo. Subjects aged ≥12 years received 40 mg or 80 mg of XOFLUZA according to body weight. Subjects aged <12 years were dosed according to body weight. Subjects were household members of influenza-infected index patients and were required to have lived with the influenza-infected index patient for ≥48 hours. Index patients were required to have onset of symptoms for ≤48 hours. The primary efficacy endpoint was the proportion of household subjects who were infected with influenza virus and presented with fever and ≥1 respiratory symptom (cough or nasal discharge/nasal congestion assessed by the subject as moderate or severe) from day 1 to day 10. The proportion of subjects ≥12 years of age who met the primary endpoint was 1% (95% CI: 0.4, 3.3) in the XOFLUZA group and 13% (95% CI: 9.6, 17.5) in the placebo group, corresponding to an estimated adjusted risk ratio of 0.10 (95% CI: 0.04, 0.28), based on randomization factors. 1,11

XOFLUZA® (baloxavir marboxil) Clipboard Icon

Treats the Flu

See the clinical efficacy for single-dose XOFLUZA. 1

XOFLUZA® (baloxavir marboxil) Stop Replication Icon

Stops Viral Replication

Single-dose XOFLUZA works differently by targeting the flu at its source to stop viral replication. 1