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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 – with no dose adjustment1

Recommended dose:

  • Once-daily 80 mg dose, taken orally in adults with PBC, with or without food
  • The tablet should not be crushed, chewed or split prior to administration.
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
  • Prior to initiation of treatment with IQIRVO the patient’s hepatic status must be known.
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:

For full list of posology and dosing information, please refer to the SMPC before prescribing IQIRVO.

Abbreviation

PBC, primary biliary cholangitis.

Reference

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

To access relevant information about Primary Biliary Cholangitis, please confirm the following:

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. Reporting of side effects. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in Google Play or Apple App Store. Side effects should also be reported to Ipsen via email at pharmacovigilance.uk-ie@ipsen.com or phone 01753 627777. By reporting side effects, you can help provide more information on the safety of this medicine.