Active Ingredient: Icatibant
Icatibant is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency.
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
10 - 30 mg
From 10 To 30 mg once every day
The recommended dose of icatibant based on body weight in children and adolescents (aged 2 to 17 years) is provided in the table below.
Dosage regimen for paediatric patients:
| Body Weight | Dose (Injection Volume) |
|---|---|
| 12 kg to 25 kg | 10 mg (1.0 ml) |
| 26 kg to 40 kg | 15 mg (1.5 ml) |
| 41 kg to 50 kg | 20 mg (2.0 ml) |
| 51 kg to 65 kg | 25 mg (2.5 ml) |
| >65 kg | 30 mg (3.0 ml) |
In the clinical trial, not more than 1 injection of Fiicatibantrazyr per HAE attack has been administered.
No dosage regimen for children aged less than 2 years or weighing less than 12 kg can be recommended as the safety and efficacy in this paediatric group has not been established.
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