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▼ This medicinal product is subject to additional monitoring. Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in Google Play or Apple App Store. Adverse events should also be reported to Ipsen via email at pharmacovigilance.uk-ie@ipsen.com or phone on 01753 627777.

IQIRVO®▼ (elafibranor) therapeutic indication1

IQIRVO is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.1

IQIRVO dosing

IQIRVO dosing

A once-daily tablet for all eligible patients

Recommended dose:

  • Once-daily 80 mg dose, taken orally in adults with PBC, with or without food
Recommended dose:

No dose adjustment required:

  • For patients with renal impairment
  • For patients over 65 years of age
  • For patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment
No dose adjustment required:

Hepatic impairment

  • Use in patients with severe hepatic impairment (Child-Pugh C) is not recommended
Hepatic impairment

In case of a missed dose:

  • Patients should take the subsequent dose at the next scheduled time point. They should not take a double dose to make up for a missed dose
In case of a missed dose:

Contact your Ipsen representative

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Abbreviation

PBC, primary biliary cholangitis.

Reference

  1. IQIRVO® (elafibranor) Summary of product characteristics (SmPC). 2024.
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