抗病毒藥品
1. Acute uncomplicated influenza (A or B) infection in patients >5 y/o
2. Postexposure prophylaxis of influenza (A or B) infection in patients >5 years of age following contact with an individual who has influenza.
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Antiviral Agent; Endonuclease Inhibitor
Baloxavir marboxil is an oral prodrug that is converted to baloxavir, an inhibitor of the endonuclease activity of a selective polymerase acidic (PA) protein, which is required for viral gene transcription, resulting in inhibition of influenza virus replication. Baloxavir has demonstrated antiviral activity against influenza A and B viruses, including strains resistant to standard current antiviral agents.

Absorption:
Tmax: 4 hrs; Effects of food: 48% decrease in Cmax, 36% decrease in AUC
Distribution:
1. Protein binding: ~93-94%
2. Vd: 1180 L
Metabolism:
Baloxavir marboxil is a prodrug, completely converted via UGT1A3 (major) and CYP3A4 (minor) to the active metabolite (baloxavir)
Excretion:
1. Renal excretion: 14.7% (Baloxavir marboxil); 3.3% ( baloxavir)
2. Fecal excretion: 80.1%
Elimination Half Life:
79.1 hrs

Hypersensitivity (eg, anaphylaxis, angioedema, urticaria, erythema multiforme)

Adverse events were not observed in animal reproduction studies. Other agents are currently recommended for the treatment of influenza in pregnant females and females up to 2 weeks postpartum.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk and benefits.

Diarrhea, abnormal behavior, anaphylactic shock, anaphylaxis, angioedema, bloody diarrhea, colitis, delirium, erythema multiforme, eyelid edema, facial swelling, hallucination, hypersensitivity reaction, melena, nonimmune anaphylaxis, skin rash, swollen tongue, urticaria, voice disorder, vomiting

Dosage:
1. <80 kg: 40 mg as a single dose within 48 hours of influenza exposure or onset of influenza symptoms
2. ≥80 kg: 80 mg as a single dose within 48 hours of influenza exposure or onset of influenza symptoms
Administration:
1. May administer with or without food.
2. Avoid administering with dairy, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (eg, calcium, iron, magnesium, selenium, zinc).

No data in <12 y/o

No dosage adjustments (no studies proved)

No dosage adjustments (no studies proved)