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

• Treatment of acute uncomplicated influenza in patients 12 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 12 years of age and older following contact with an individual who has influenza.

Treatment and Post-Exposure Prophylaxis of Influenza: Baloxavir Marboxil 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. Baloxavir Marboxil should be taken with or without food.

Recommended Single Oral Dose in Patients 12 Years of Age and Older:

• Less than 80 kg: One 40 mg tablet
• At least 80 kg: One 80 mg tablet

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

Adverse events reported in at least 1% of adult and adolescent influenza subjects treated with Baloxavir Marboxil included diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%).

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

Risk of bacterial infection: Serious bacterial infections may begin with influenza-like symptoms or may coexist with, or occur as, a complication of influenza. Baloxavir Marboxil has not been shown to prevent such complications. Prescribers should be alert to potential secondary bacterial infections and treat them as appropriate.

Pregnancy & Lactation

There are no adequate and well-controlled studies with Baloxavir Marboxil 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. 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.