HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciBal safely and effectively. See full prescribing information for LuciBal.

INDICATIONS AND USAGE

LuciBal is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for:

• Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications.

• Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.

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 LuciBal.

DOSAGE AND ADMINISTRATION

Treatment and Post-Exposure Prophylaxis of Influenza

LuciBal should be taken as a single dose as soon as possible and within 48 hours of influenza symptom onset for treatment of acute uncomplicated influenza or following contact with an individual who has influenza. LuciBal may be taken with or without food.

DOSAGE FORMS AND STRENGTHS

Tablets: 20 mg×4 tablets

CONTRAINDICATIONS

LuciBal is contraindicated in patients with a history of hypersensitivity to baloxavir marboxil or any of its ingredients.

WARNINGS AND PRECAUTIONS

• Hypersensitivity such as anaphylaxis, angioedema, urticaria, and erythema multiforme: Initiate appropriate treatment if an allergic-like reaction occurs or is suspected.

• Increased incidence of Treatment-Emergent Resistance in Patients Less Than 5 Years of Age: LuciBal 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 with reduced susceptibility to baloxavir (resistance) was higher in pediatric subjects younger than 5 years of age than older subjects.

• Risk of bacterial infection: Serious bacterial infections may begin with influenza-like symptoms or may coexist with, or occur as, a complication of influenza. LuciBal 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 influenza subjects treated with LuciBal included diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%).

Adverse events reported in at least 5% of pediatric subjects (5 to < 12 years) treated with LuciBal included vomiting (5%) and diarrhea (5%).

DRUG INTERACTIONS

• Avoid coadministration of LuciBal with dairy products, calciumfortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc).

• Live attenuated influenza vaccines may be affected by antivirals.

Storage

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.