IQIRVO

Posology The recommended dose is 80 mg once daily with or without food. 2). 2). Hepatic impairment Prior to initiation of treatment with Elafibranor the patient's hepatic status must be known. No dose adjustment is necessary in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.

Whether the patient has decompensated cirrhosis (including Child-Pugh C) or has had a prior decompensation event should be determined prior to initiation of treatment because the safety and efficacy of elafibranor have not been established in patients with PBC with severe hepatic impairment.

2). Paediatric population There is no relevant use of elafibranor in the paediatric population (below 18 years of age) for the indication of PBC. 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. Method of administration For oral use. Take one tablet once daily. The tablet should not be crushed, chewed or split prior to administration.

Summary of the safety profile In the pivotal phase 3 ELATIVE study, 161 participants were randomised in a 2:1 ratio to receive elafibranor 80 mg (n=108) or placebo (n=53) for at least 52 weeks. 00 weeks in the elafibranor and placebo groups, respectively.

1%). These were non-serious and mild to moderate in severity. 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. Post-marketing experience Not applicable Paediatric population Not applicable 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

7% of participants receiving placebo. 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.

7% in elafibranor group compared to 0% in placebo group). In addition to these reported CPK increases, there was one case of rhabdomyolysis which occurred in the pivotal phase 3 ELATIVE study in a participant with cirrhosis and ongoing treatment with an HMG-CoA reductase inhibitor.

CPK should be evaluated prior to initiation of elafibranor treatment to determine the baseline CPK level and thereafter, according to the routine patient management. Caution should be used in patients with predisposing factors including old age (>65 years), hypothyroidism, personal or familial history of hereditary muscular disorders, severe infection, trauma, surgery, disturbances of hormone or electrolyte imbalance or alcohol abuse.

Periodic CPK measurements may be considered in patients starting elafibranor treatment, especially those on concomitant HMG-CoA reductase inhibitors. Patients on elafibranor treatment should be advised to report promptly any unexplained muscle symptoms such as pain, soreness, or weakness to their treating physician, especially if accompanied by malaise or fever.

8), and levels monitored as per standard medical practise. Embryo-Foetal Toxicity Based on data from animal studies, elafibranor may cause foetal harm when administered to a pregnant woman. 6). 6). The pregnancy status of women of childbearing potential should be checked prior to initiation of elafibranor treatment.

Women of childbearing potential should be advised to use effective contraception during treatment and for 3 weeks following the final dose of elafibranor. Hypersensitivity Reactions If severe hypersensitivity reactions occur, permanently discontinue Iqirvo.

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