Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Ipsen Pharma, 65 quai George Gorse, 92100 Boulogne-Billancourt, France
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 patients unable to tolerate UDCA.
The recommended dose is 80 mg once daily.
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.
No dose adjustment is necessary in patients older than 65 years of age (see section 5.2).
There is no relevant use of elafibranor in the paediatric population (below 18 years of age) for the indication of PBC.
No dose adjustment is necessary in patients with renal impairment (see section 5.2).
No dose adjustment is necessary in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.
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).
For oral use.
In the event of suspected overdose, patients should be carefully observed, and appropriate symptomatic treatment and supportive care should be initiated.
3 years.
This medicinal product does not require any special storage conditions.
40 mL high-density polyethylene (HDPE) bottle with a polypropylene child-resistant screw cap.
Each bottle contains 30 film-coated tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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