This information is not for clinical use. These highlights do not include all the information needed to use Xofluza safely and effectively. Before taking Xofluza please consult with your doctor. See full prescribing information for Xofluza.

Indications And Usage

XOFLUZA™ is indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours. XOFLUZA™ is a polymerase acidic (PA) endonuclease inhibitor indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours. (1) Limitations of Use: Influenza viruses change over time, and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use XOFLUZA. (1) Limitations of Use: Influenza viruses change over time, and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use XOFLUZA [see Microbiology (12.4) and Clinical Studies (14)].

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Dosage And Administration

Patient Body Weight (kg) Recommended Oral Dose
40 kg to less than 80 kg Single dose of 40 mg
At least 80 kg Single dose of 80 mg

Dosage Forms And Strengths

XOFLUZA 20 mg Tablets are white to light yellow, oblong shaped film-coated tablets debossed with "772" on one side and "20" on the other side. XOFLUZA 40 mg Tablets are white to light yellow, oblong shaped film-coated tablets debossed with "BXM40" on one side. Tablets: 20 mg and 40 mg (3) Chemical Structure

Contraindications

XOFLUZA is contraindicated in patients with a history of hypersensitivity to baloxavir marboxil or any of its ingredients. XOFLUZA is contraindicated in patients with a history of hypersensitivity to baloxavir marboxil or any of its ingredients. (4)

Warning and Cautions

Risk of Bacterial Infection: Serious bacterial infections may begin with influenza-like symptoms, may coexist with, or occur as a complication of influenza. XOFLUZA has not been shown to prevent such complications. Prescribers should be alert to potential secondary bacterial infections and treat them as appropriate. (5.1) 5.1 Risk of Bacterial Infections There is no evidence of efficacy of XOFLUZA in any illness caused by pathogens other than influenza viruses. Serious bacterial infections may begin with influenza-like symptoms, may coexist with, or occur as a complication of influenza. XOFLUZA has not been shown to prevent such complications. Prescribers should be alert to potential secondary bacterial infections and treat them as appropriate.

Adverse Reactions

Adverse events reported in at least 1% of adult and adolescent subjects treated with XOFLUZA included diarrhea (3%), bronchitis (2%), nasopharyngitis (1%), headache (1%) and nausea (1%). (6.1) 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 Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety profile of XOFLUZA is based on data from 2 placebo-controlled trials, in which a total of 910 subjects received XOFLUZA: 834 (92%) were adults (18 years and older) and 76 (8%) were adolescents (12 to less than 18 years). Of these, 710 subjects received XOFLUZA at the recommended dose. In Trial 1, adult subjects 20 to 64 years of age received a single oral dose of XOFLUZA or placebo. In Trial 2, adult subjects 20 to 64 years of age received XOFLUZA, placebo as a single oral dose on Day 1, or oseltamivir twice a day for 5 days, and adolescent subjects 12 to less than 20 years of age received XOFLUZA or placebo as a single oral dose. Table 2 displays the most common adverse events (regardless of causality assessment) reported in at least 1% of adult and adolescent subjects who received XOFLUZA at the recommended dose in Trials 1 and 2. Table 2 Incidence of Adverse Events Occurring in Greater Than or Equal to 1% of Subjects Receiving XOFLUZA in the Acute Uncomplicated Influenza Trials Adverse Event XOFLUZA (N = 710) Placebo (N = 409) Diarrhea 3% 5% Bronchitis 2% 4% Nausea 1% 1% Nasopharyngitis 1% 1% Headache 1% 2%

Drug Interactions

Avoid co-administration of XOFLUZA with polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc). (7.1) Live attenuated influenza vaccines may be affected by antivirals. (7.2) 7.1 Effect of Other Drugs on XOFLUZA Co-administration with polyvalent cation-containing products may decrease plasma concentrations of baloxavir which may reduce XOFLUZA efficacy. Avoid co-administration of XOFLUZA with polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc). 7.2 Vaccines The concurrent use of XOFLUZA with intranasal live attenuated influenza vaccine (LAIV) has not been evaluated. Concurrent administration of antiviral drugs may inhibit viral replication of LAIV and thereby decrease the effectiveness of LAIV vaccination. Interactions between inactivated influenza vaccines and XOFLUZA have not been evaluated.

Use In Specific Populations

Safety and efficacy in patients less than 12 years of age or weighing less than 40 kg have not been established. (8.4) 8.1 Pregnancy Risk Summary There are no available data on XOFLUZA use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. There are risks to the mother and fetus associated with influenza virus infection in pregnancy (see Clinical Considerations). In animal reproduction studies, no adverse developmental effects were observed in rats or rabbits with oral administration of baloxavir marboxil at exposures approximately 5 (rats) and 7 (rabbits) times the systemic baloxavir exposure at the maximum recommended human dose (MRHD) (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Pregnant women are at higher risk of severe complications from influenza, which may lead to adverse pregnancy and/or fetal outcomes including maternal death, stillbirth, birth defects, preterm delivery, low birth weight and small for gestational age. Data Animal Data Baloxavir marboxil was administered orally to pregnant rats (20, 200, or 1,000 mg/kg/day from gestation day 6 to 17) and rabbits (30, 100, or 1,000 mg/kg/day from gestation day 7 to 19). No adverse embryo-fetal effects were observed in rats up to the highest dose of baloxavir marboxil (1,000 mg/kg/day), resulting in systemic baloxavir exposure (AUC) of approximately 5 times the exposure at the MRHD. In rabbits, fetal skeletal variations occurred at a maternally toxic dose (1,000 mg/kg/day) resulting in 2 abortions out of 19 pregnancies. No adverse maternal or embryo-fetal effects were observed in rabbits at the middle dose (100 mg/kg/day) resulting in systemic baloxavir exposure (AUC) approximately 7 times the exposure at the MRHD. In the prenatal and postnatal development study in rats, baloxavir marboxil was administered orally at 20, 200, or 1,000 mg/kg/day from gestation day 6 to postpartum/lactation day 20. No significant effects were observed in the offspring at maternal systemic baloxavir exposure (AUC) approximately 5 times the exposure at the MRHD. 8.2 Lactation Risk Summary There are no data on the presence of baloxavir marboxil in human milk, the effects on the breastfed infant, or the effects on milk production. Baloxavir and its related metabolites were present in the milk of lactating rats (see Data). The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for XOFLUZA and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. Data In a lactation study, baloxavir and its related metabolites were excreted in the milk of lactating rats administered baloxavir marboxil (1 mg/kg) on postpartum/lactation day 11, with peak milk concentration approximately 5 times that of maternal plasma concentrations occurring 2 hours post-dose. No effects of baloxavir marboxil on growth and postnatal development were observed in nursing pups at the highest oral dose tested in rats. Maternal systemic exposure was approximately 5 times the baloxavir exposure in humans at the MRHD. 8.4 Pediatric Use The safety and effectiveness of XOFLUZA for the treatment of influenza have been established in pediatric patients 12 years of age and older weighing at least 40 kg [see Adverse Reactions (6.1) and Clinical Studies (14) ]. The safety and effectiveness of XOFLUZA have not been established in pediatric patients less than 12 years of age. The use of XOFLUZA in pediatric patients 12 years of age and older weighing at least 40 kg is supported by one randomized, double-blind, controlled trial [see Clinical Studies (14)]. In this phase 3 trial, 118 adolescents were randomized to receive either XOFLUZA (N=80) or placebo (N=38). The median time to alleviation of symptoms in adolescent subjects was 54 hours compared to 93 hours for subjects who received placebo. Adverse reactions reported in adolescents were similar to those reported in adults [see Adverse Reactions (6.1)]. 8.5 Geriatric Use Clinical trials of XOFLUZA did not include subjects 65 years of age and older to determine whether they respond differently from younger subjects.