Recurrent attacks of hereditary angioedema (HAE)

Active Ingredient: Garadacimab

Indication for Garadacimab

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

Garadacimab 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:

Initial loading dose of 400 mg on the first day of treatment, followed by a monthly dose of 200 mg

For:

Dosage regimens

Subcutaneous, 400 milligrams garadacimab, 1 one dose. Afterwards, subcutaneous, 200 milligrams garadacimab, once monthly.

Detailed description

The recommended dose of garadacimab, in adults and children 12 years of age and above, is an initial loading dose of 400 mg administered subcutaneously on the first day of treatment, followed by a monthly dose of 200 mg.

Consideration should be given to discontinuing treatment in patients with normal C1-INH HAE (nC1-INH) who have shown insufficient reduction in attacks after 3 months of treatment.

Garadacimab is not intended for the treatment of acute HAE attacks.

Missed doses

If a dose of garadacimab is missed, the patient should be instructed to administer the dose as soon as possible.

Dosage considerations

The injection should be restricted to the following injection sites: the abdomen, the thighs and the upper outer arms. Rotation of the injection site is recommended.

Active ingredient

Garadacimab

Garadacimab is a fully human IgG4/lambda recombinant monoclonal antibody which binds to the catalytic domain of activated Factor XII (FXIIa and βFXIIa) and inhibits its catalytic activity. The inhibition of FXIIa, the first factor activated in the contact system, prevents HAE attacks by blocking the activation of prekallikrein to kallikrein and the generation of bradykinin, which is associated with inflammation and swelling in HAE attacks.

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