XOFLUZA (baloxavir marboxil)

Baloxavir marboxil is a prodrug that is almost completely converted to its active metabolite, baloxavir, following oral administration. Baloxavir pharmacokinetic parameters are presented for healthy adults and adolescents as the mean [% coefficient of variation (%CV)], unless otherwise specified, in Table 5 . Absorption, distribution, metabolism, and elimination data for XOFLUZA is presented in Table 6 .

Table 5Pharmacokinetic Parameters of Plasma Baloxavir in Adults and Adolescents (≥ 12 Years...

14.1 Treatment of Acute Uncomplicated Influenza—Otherwise Healthy Subjects (12 Years of Age and Older) Two randomized, controlled, double-blinded clinical trials conducted in two different influenza seasons evaluated efficacy and safety of XOFLUZA in otherwise healthy subjects with acute uncomplicated influenza. In Trial T0821, a placebo-controlled phase 2 dose-finding trial, a single oral dose of XOFLUZA was compared with placebo in 400 adult subjects 20 to 64 years of age in Japan. All subjects in Trial T0821 were Asian, the majority of subjects were male (62%), and the mean age was 38 years...

Adverse events reported in at least 1% of adult and adolescent influenza subjects treated with XOFLUZA included diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%). ( 6.1 ) Adverse events reported in at least 5% of pediatric subjects (5 to < 12 years) treated with XOFLUZA included vomiting (5%) and diarrhea (5%). To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience B...

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 [see Warnings and Precautions (5.1) ]. XOFLUZA is contraindicated in patients with a history of hypersensitivity to baloxavir marboxil or any of its ingredients. ( 4 )

Hypersensitivity such as anaphylaxis, angioedema, urticaria, and erythema multiforme: Initiate appropriate treatment if an allergic-like reaction occurs or is suspected. ( 5.1 ) Increased incidence of Treatment-Emergent Resistance in Patients Less Than 5 Years of Age: XOFLUZA is not indicated in patients less than 5 years of age due to increased incidence of treatment-emergent resistance in this age group . In clinical trials, incidence of virus with treatment-emergent substitutions associated w...

7 DRUG INTERACTIONS Avoid coadministration of XOFLUZA with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc). ( 2.1 , 7.1 ) Live attenuated influenza vaccines may be affected by antivirals. ( 7.2 ) 7.1 Effect of Other Drugs on XOFLUZA Baloxavir may form a chelate with polyvalent cat...