EKTERLY

Posology The recommended dose of Ekterly is 300 mg administered at the earliest recognition of an attack. An additional dose may be taken if needed. 2). Renal impairment No dose adjustment is required for patients with renal impairment.

Hepatic impairment No dose adjustment of Ekterly is required for patients with mild or moderate hepatic impairment (Child-Pugh A or B). Use of Ekterly in patients with severe hepatic impairment (Child-Pugh C) is not recommended. Paediatric population The safety and efficacy of sebetralstat in children under 12 years of age have not been established.

No data are available. Patients taking strong CYP3A4 inhibitors In patients who are taking a strong CYP3A4 inhibitor a single dose of 300 mg is recommended when treating an HAE attack. Patients taking strong or moderate CYP3A4 inducers In patients who are taking strong or moderate CYP3A4 inducers a single dose of 900 mg (3 x 300 mg tablets) is recommended when treating an HAE attack.

Method of administration For oral use. 2).

Summary of the safety profile Ekterly has been administered to a total of 411 healthy subjects and 239 hereditary angioedema patients. In clinical studies used for registration, 1,945 HAE attacks have been treated with Ekterly. 2% of patients).

The reported events of headache were generally mild to moderate in severity, non-serious and resolved without any further intervention. Tabulated list of adverse reactions The frequency of all adverse reactions listed in the table below is defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).

Table 1. Summary of adverse reactions by system organ class and frequency System organ class Adverse Reaction Frequency Nervous system disorders Headache Common Dyspepsia Common Nausea Uncommon Gastrointestinal disorders Abdominal pain Uncommon General disorders and administration site conditions Fatigue Uncommon Musculoskeletal and connective tissue disorders Back pain Uncommon Vascular disorders Hot flush Uncommon Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Laryngeal attacks:

Following treatment of laryngeal attacks with Ekterly, advise patients to seek immediate medical attention. Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.

Sebetralstat is an in vitro inhibitor of MATE1, MATE2-K and OCT2 and co- administration may raise exposure to substrates of these transporters such as metformin. Clinicians should consider monitoring blood lactate and renal function in patients who carry a higher risk for lactic acidosis.

1.