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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: o otherwise healthy, or o 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
Baloxavir, derived from the prodrug baloxavir marboxil, is a cap-dependent endonuclease protein inhibitor within the polymerase acidic protein (PA) subunit of influenza A and B viruses. It blocks influenza virus replication by inhibiting the initiation of mRNA synthesis. Baloxavir is effective against influenza type A and B viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1).
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.
Baloxavir may form a chelate with polyvalent cations in antacids, which may decrease plasma concentrations of baloxavir. Avoid milk and dairy products. Baloxavir may form a chelate with polyvalent cations such as calcium in dairy products, which may decrease plasma concentrations of baloxavir.
Baloxavir Marboxil is contraindicated in patients with a history of hypersensitivity to baloxavir marboxil or any of its ingredients.
The most common side effects of Baloxavir Marboxilfor treatment of the flu in adults and adolescents (12 years of age and older) were diarrhea, bronchitis, nausea, sinusitis, and headache.
There are no adequate and well-controlled studies with Baloxavir Marboxil in pregnant women to inform a drugassociated 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.
Clinical trials and during postmarketing experience. In the majority of cases reporting overdose, no adverse reactions were reported. Data are insufficient to determine what symptoms may be anticipated as a result of an overdose.
Store at room temperature (20°C to 25°C).