Active Ingredient: Sebetralstat
Sebetralstat is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A
Oral, 300 milligrams sebetralstat, one dose.
Regimen B
Oral, 300 milligrams sebetralstat, one dose, over the duration of 3 hours. Afterwards, in case that there is poor response to treatment, oral, 300 milligrams sebetralstat, one dose.
The recommended dose is 300 mg administered at the earliest recognition of an attack. A second dose may be taken 3 hours after the first dose if response is inadequate, or if symptoms worsen or recur. No more than two doses should be administered in a 24 hour period.
Consideration should be given to discontinuing treatment in patients with normal C1-INH HAE (nC1-INH) if a clinical response is not observed.
No dose adjustment is required for patients above 65 years of age.
No dose adjustment is required when taking weak CYP3A4 inducers.
In patients taking moderate or strong CYP3A4 inducers a single dose of 900 mg is recommended when treating an HAE attack.
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