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Posology The recommended dose is 80 mg once daily. Missed dose 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.

2). Paediatric population There is no relevant use of elafibranor in the paediatric population (below 18 years of age) for the indication of PBC. 2). 3 Hepatic impairment 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. 2). Method of administration For oral use.

9%). These were non-serious, mild to moderate, occurred early in treatment and tended to resolve within days to a few weeks without any dose modification or supportive measures. 7%). Tabulated list of adverse reactions Within the system organ class, the adverse reactions are listed by frequency using the following categories: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), not known (cannot be estimated from the available data).

3%) participants in the placebo group experienced headache. 7% compared to 0% respectively). 7%) participants in the elafibranor group and no participants in the placebo group had clinically significant blood CPK increase, leading to drug discontinuation.

In 2 of the 4 participants, the CPK was >5 x upper limit of normal (ULN). All events were non-serious and mild to moderate in intensity. Two of the participants also experienced associated symptom of myalgia. At baseline, mean CPK values were similar between the treatment groups and within normal range; values at week 52 remained within normal range in both groups.

0) U/L in the placebo group. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Liver related events Increases in liver biochemical tests including transaminases and bilirubin levels have been reported in participants receiving elafibranor. Clinical and laboratory assessment of liver function should be done prior to initiation of elafibranor treatment and thereafter according to routine patient management.

If increases in liver biochemical tests and/or liver dysfunction are observed, prompt investigation of the cause is recommended and interruption of elafibranor treatment should be considered. 8). CPK should be evaluated prior to initiation of elafibranor treatment and thereafter according to routine patient management.

Periodic CPK measurements may be considered in patients starting elafibranor treatment, especially those on concomitant HMG-CoA reductase inhibitors. 8). 6). 3). Women with childbearing potential should be informed about this. Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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1. 6).