Xofluza Tablet

Xofluza is an influenza virus 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 and who are:

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

Xofluza is also indicated for post-exposure prophylaxis (PEP) of influenza in patients 12 years of age and older following contact with an individual who has influenza.

Baloxavir Marboxil is an antiviral polymerase endonuclease inhibitor. Baloxavir is a film-coated tablet for oral administration. The active component of Baloxavir is Baloxavir Marboxil. Baloxavir Marboxil is a prodrug that is converted by hydrolysis to Baloxavir, the active form that exerts anti-influenza virus activity. Baloxavir inhibits the endonuclease activity of the polymerase acidic (PA) protein, an influenza virus-specific enzyme in the viral RNA polymerase complex required for viral gene transcription, resulting in inhibition of influenza virus replication.

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.

Avoid coadministration of Xofluza with dairy products, calcium-fortified 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.

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 Xofluza included diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%).

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.

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. Xofluza has not been shown to prevent such complications. Prescribers should be alert to potential secondary bacterial infections and treat them as appropriate.

Treatment of an overdose of Xofluza should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with Xofluza.

Respiratory viral infections (Influenza)

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.