Baloxavir Marboxil is a polymerase acidic (PA) endonuclease inhibitor used for the treatment of acute uncomplicated influenza in patients aged 12 years and older who have had symptoms for no more than 48 hours and who are:

• otherwise healthy, or
• at increased risk of influenza-related complications

Baloxavir is also indicated for post-exposure prophylaxis (PEP) of influenza in patients aged 12 years and above following contact with an infected individual.

Baloxavir Marboxil is an antiviral polymerase endonuclease inhibitor. It is available as a film-coated tablet for oral use. The active component, Baloxavir, is formed when Baloxavir Marboxil is converted in the body by hydrolysis. Baloxavir works by blocking the endonuclease activity of the polymerase acidic (PA) protein, an enzyme specific to the influenza virus that is essential for viral gene transcription. This action prevents the influenza virus from replicating and spreading in the body.

Take a single dose of Baloxavir orally within 48 hours of symptom onset with or without food. The dose of Baloxavir depends on weight

40 to less than 80 kg: Two 20 mg tablets taken at the same time for a total single dose of 40 mg.
At least 80 kg: Two 40 mg tablets taken at the same time for a total single dose of 80 mg.
Pediatric Use: The safety and effectiveness of Baloxavir Marboxil for the treatment of acute uncomplicated influenza
have been established in pediatric patients 12 years of age and older weighing at least 40 kg.

Do not take Baloxavir Marboxil at the same time as dairy products, calcium-fortified drinks, laxatives containing multiple minerals, antacids, or oral supplements such as calcium, iron, magnesium, selenium, or zinc. These may reduce the absorption and effectiveness of Baloxavir. Live attenuated influenza vaccines may also be less effective if taken while using antiviral medicines like Baloxavir.

Baloxavir Marboxil should not be used in patients who have a known allergy or hypersensitivity to Baloxavir Marboxil or any of its ingredients.

In adults and adolescents treated with Baloxavir Marboxil, the most commonly reported side effects (occurring in at least 1% of patients) include diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%).

There are no well-controlled studies on the use of Baloxavir Marboxil in pregnant women, so the risk of harmful effects on the developing baby is unknown. Influenza infection during pregnancy can itself pose risks to both mother and fetus. It is also not known whether Baloxavir Marboxil passes into human breast milk or what effects it may have on a breastfed baby or on milk production.

Hypersensitivity Reactions: Severe allergic reactions such as anaphylaxis, angioedema, hives (urticaria), or skin rashes (erythema multiforme) may occur. If any allergic-like reaction happens or is suspected, start appropriate medical treatment immediately.

Risk of Bacterial Infection: Serious bacterial infections can sometimes start with flu-like symptoms, coexist with influenza, or develop as a complication. Baloxavir Marboxil does not prevent these bacterial infections. Doctors should be vigilant for possible secondary bacterial infections and treat them appropriately.

If an overdose of Baloxavir occurs, treatment should focus on general supportive care, including monitoring vital signs and closely observing the patient’s condition. There is no specific antidote available for a Baloxavir overdose.

Respiratory viral infections (Influenza)

Store Baloxavir at a temperature below 30°C, away from light and moisture. Keep out of reach of children.