- Approval Id
- 7d4a7643994e2b6f
- Drug Name
- IQIRVO® FILM-COATED TABLET 80MG
- Product Name
- IQIRVO® FILM-COATED TABLET 80MG
- Approval Number
- SIN17332P
- Approval Date
- 2025-09-18
- Registrant
- IPSEN PHARMA SINGAPORE PTE. LTD.
- Licence Holder
- IPSEN PHARMA SINGAPORE 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 is 80 mg once daily with or without food.</p>
<p><u>Special Populations</u></p>
<p><em>Elderly patients (65 years of age and above)</em><br>
No dose adjustment is necessary in patients older than 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 necessary in patients with renal impairment (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>Hepatic impairment</em><br>
No dose adjustment is necessary in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.<br>
The safety and efficacy of elafibranor have not been established in patients with PBC with severe hepatic impairment. Use in patients with severe hepatic impairment (Child-Pugh C) is not recommended (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>Paediatric population</em><br>
There is no relevant use of elafibranor in the paediatric population (below 18 years of age) for the indication of PBC.</p>
<p><em>Missed dose</em><br>
If a dose of elafibranor is missed, the patient should not take the missed dose and instead take their subsequent dose at the next scheduled time point. The patient should not take a double dose to make up for the missed dose.</p>
<p><u>Method of administration</u></p>
<p>For oral use.<br>
Take one tablet once daily.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>IQIRVO® is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adult patients with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.</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>
