Recurrent attacks of hereditary angioedema (HAE)

Active Ingredient: Berotralstat

Indication for Berotralstat

Population group: only adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Preventive action

Berotralstat is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.

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

150 mg once daily

Route of admnistration

Oral

Defined daily dose

150 - 150 mg

Dosage regimen

From 150 To 150 mg once every day

Detailed description

The recommended dose for adults and adolescents aged 12 years and older weighing ≥ 40 kg is 150 mg berotralstat once daily.

Missed doses

If a dose of berotralstat is missed, the patient should take the forgotten dose as soon as possible without exceeding one dose per day.

Berotralstat is not intended for treatment of acute HAE attacks.

Dosage considerations

The capsule can be taken at any time of the day, with food.

Active ingredient

Berotralstat

Berotralstat is an inhibitor of plasma kallikrein. In patients with hereditary angioedema (HAE) due to C1-INH deficiency or dysfunction, normal regulation of plasma kallikrein activity is impaired, which leads to uncontrolled increases in plasma kallikrein activity and bradykinin release, resulting in HAE attacks consisting of swelling (angioedema).

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