Influenza

Active Ingredient: Baloxavir marboxil

Indication for Baloxavir marboxil

Population group: only infants (40 days - 1 year old) , children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Curative procedure

Baloxavir marboxil is indicated for the treatment of uncomplicated influenza in patients aged 3 weeks and above.

For this indication, competent medicine agencies globally authorize below treatments:

For patients weighting <20 kg 2 mg per kg of body weight, for patients weighting ≥20 - <80 kg 40 mg, and for patients weighting ≥80 kg 80 mg, single dose

For:

Dosage regimens

Regimen A, in the case that patient age in days is ≥ 21 and patient weight is < 20 kg :

Oral, 2 milligrams baloxavir marboxil per kilogram of body weight, one dose.

Regimen B, in the case that patient age in days is ≥ 21 and patient weight is ≥ 20 kg and patient weight is < 80 kg :

Oral, 40 milligrams baloxavir marboxil, one dose.

Regimen C, in the case that patient age in days is ≥ 21 and patient weight is ≥ 80 kg :

Oral, 80 milligrams baloxavir marboxil, one dose.

Detailed description

A single dose of baloxavir marboxil should be taken as soon as possible within 48 hours of symptom(s) onset.

Adults, adolescents, children and infants (≥3 weeks of age)

The recommended single oral dose of baloxavir marboxil is determined by body weight.

Baloxavir marboxil dosing by patient body weight (≥3 weeks of age):

Body weight (kg)Recommended single dose
of oral suspension
<20 kg2 mg per kg of body weight
≥20 kg to <80 kg40 mg
≥80 kg80 mg

There are no clinical data on the use of a repeat dose of baloxavir marboxil for the treatment of uncomplicated influenza or for post-exposure prophylaxis in any one influenza season.

Dosage considerations

Baloxavir marboxil should not be taken with products that contain polyvalent cations such as laxatives, antacids or oral supplements containing iron, zinc, selenium, calcium or magnesium.

Active ingredient

Baloxavir marboxil

Baloxavir marboxil is a prodrug that is converted by hydrolysis to baloxavir, the active form that exerts anti-influenza activity. Baloxavir acts on the cap-dependent endonuclease (CEN), an influenza virus-specific enzyme in the polymerase acidic (PA) subunit of the viral RNA polymerase complex and thereby inhibits the transcription of influenza virus genomes resulting in inhibition of influenza virus replication.

Read more about Baloxavir marboxil

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