CATALENT NOTTINGHAM LIMITED (UNITED KINGDOM)🇸🇬 Health Sciences Authority
Approval Date
Nov 12, 2025
Approval ID
3e02417a01b5d93b
Company
CATALENT NOTTINGHAM LIMITED (UNITED KINGDOM)
Type
Therapeutic
Approval Details
Approval Id
3e02417a01b5d93b
Drug Name
EKTERLY FILM-COATED TABLETS 300 MG
Product Name
EKTERLY FILM-COATED TABLETS 300 MG
Approval Number
SIN17392P
Approval Date
2025-11-12
Registrant
PHARMA TO MARKET PTE. LTD.
Licence Holder
PHARMA TO MARKET PTE. LTD.
Drug Type
Therapeutic
Forensic Classification
PRESCRIPTION ONLY MEDICINES
Dosage Form
TABLET, FILM COATED
Dosage
<p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p>The recommended dose of Ekterly is 300 mg administered at the earliest recognition of an attack. An additional dose may be taken if needed.</p>
<p><u>Special populations</u></p>
<p><em>Elderly population</em><br>
No dose adjustment is required for patients above 65 years of age (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Renal impairment</em><br>
No dose adjustment is required for patients with renal impairment.</p>
<p><em>Hepatic impairment</em><br>
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.</p>
<p><em>Paediatric population</em><br>
The safety and efficacy of sebetralstat in children under 12 years of age have not been established.<br>
No data are available.</p>
<p><em>Patients taking strong CYP3A4 inhibitors</em><br>
In patients who are taking a strong CYP3A4 inhibitor a single dose of 300 mg is recommended when treating an HAE attack. Use of an additional dose is not recommended.</p>
<p><em>Patients taking strong or moderate CYP3A4 inducers</em><br>
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.</p>
<p><u>Method of administration</u></p>
<p>For oral use. The film-coated tablets can be taken with or without food (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
Route Of Administration
ORAL
Indication Info
<p><strong>4.1 Therapeutic indications</strong></p>
<p>Ekterly is indicated for the treatment of hereditary angioedema (HAE) attacks in adult and adolescents aged 12 years and older.</p>
Contraindications
<p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
