EKTERLY Film-coated tablet Ref.[115832] Active ingredients: Sebetralstat

The decision to initiate treatment with oral sebetralstat should be made by a healthcare professional experienced in the management of patients with HAE.

Posology

Adults and adolescents aged 12 years and older

The recommended dose is one 300 mg tablet of Ekterly 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.

Patients with normal C1-INH HAE (nC1 INH)

Consideration should be given to discontinuing treatment in patients with normal C1-INH HAE (nC1-INH) if a clinical response is not observed (see sections 4.4 and 5.1).

Elderly

No dose adjustment is required for patients above 65 years of age (see section 5.2).

Renal impairment

No dose adjustment is required for patients with renal impairment (see section 5.2).

Hepatic impairment

No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh A or B).

Use in patients with severe hepatic impairment (Child-Pugh C) is not recommended (see section 5.2).

In patients with moderate hepatic impairment who are taking a strong CYP3A4 inhibitor a single dose of 300 mg is recommended when treating an HAE attack (see section 4.5).

Patients taking CYP3A4 inducers

No dose adjustment is required when taking weak CYP3A4 inducers. In patients taking moderate or strong CYP3A4 inducers a single dose of 900 mg (3 x 300 mg tablets) is recommended when treating an HAE attack (see section 4.5).

Paediatric population

Safety and efficacy in children less than 12 years have not been established. No data are available.

Method of administration

Ekterly is intended for oral use.

The film-coated tablets can be taken with or without food (see section 5.2).

No case of overdose has been reported in clinical trials. There is no available information to identify potential signs and symptoms of overdose. If symptoms should occur, symptomatic treatment is recommended. There is no antidote available.

3 years.

This medicinal product does not require any special storage conditions.

oPA/Al/PVC with aluminium lidding blisters (1 film-coated tablet per blister).

The film-coated tablets are packed in a blister encased in a child-resistant cardboard wallet. The wallets are contained in a cardboard box.

Pack size: 4 or 6 film-coated tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.