<p>Orladeyo is a medicine used to prevent attacks of hereditary angioedema (swelling) in patients from 12 years of age. Patients with hereditary angioedema have attacks of rapid swelling such as in the face, throat, arms and legs, or around the gut.</p><p>Hereditary angioedema is rare, and Orladeyo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 27 June 2018. Further information on the orphan designation can be found <a href="/en/medicines/human/orphan-designations/eu-3-18-2028" data-entity-type="node" data-entity-uuid="c078b692-7b10-4a1c-ac4f-76ee56a27a12" data-entity-substitution="canonical">here</a>.</p><p>Orladeyo contains the active substance berotralstat.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.</p> </div>
Therapeutic Area (MeSH)
ATC Code
B06AC
ATC Item
N/A
Pharmacotherapeutic Group
Other hematological agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| berotralstat dihydrochloride | N/A | berotralstat dihydrochloride |
EMA Name
Orladeyo
Medicine Name
Orladeyo
Aliases
N/ANo risk management plan link.
