Prescribing Information for Ireland

IQIRVO^▼ (elafibranor) 80 mg film-coated tablets

See full Summary of Product Characteristics (SmPC) before prescribing. Available at [www.medicines.ie](https://www.medicines.ie)

Presentation: Film-coated, round orange tablets containing 80mg of elafibranor. Indications: 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. Dosage and Administration: Iqirvo should be taken orally. Take one tablet once daily with or without food. The tablet should not be crushed, chewed, or split prior to administration. 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. Additional dosing information: No dose adjustment is necessary in patients older than 65 years of age (There is no supporting data on using Elafibranor in those over 80 years of age). There is no relevant use of elafibranor in the paediatric population (below 18 years of age) for the indication of PBC. Renal impairment: No dose adjustment is necessary in patients with renal impairment. 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. Use in patients with severe hepatic impairment (Child-Pugh C) is not recommended. Contraindications: Known hypersensitivity to the active substance or to any of the following excipients: Microcrystalline cellulose, Povidone, Croscarmellose sodium, Anhydrous colloidal silica, Magnesium stearate, Polyvinyl alcohol-part hydrolysed, Titanium dioxide (E171), Macrogol, Talc, Iron oxide yellow (E172), Iron oxide red (E172). Warnings and precautions: Liver related events: Increases in liver biochemical tests including transaminases and bilirubin increase levels have been reported. 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. Elevated blood creatine phosphokinase and muscle injury: Increases in blood creatine phosphokinase (CPK) have been reported. Rhabdomyolysis has been reported 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 levels and should be monitored thereafter according to 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 should be considered in patients starting elafibranor treatment, especially those on concomitant HMG-CoA reductase inhibitors. Advise patients to report any unexplained muscle symptoms such as pain, soreness, or weakness especially if accompanied by malaise or fever. If increases in CPK or unexplained signs and symptoms of muscle injury are observed, prompt investigation of the cause is recommended. Interruption of elafibranor treatment should be considered and levels monitored as per standard medical practice. Embryo-Foetal Toxicity: Based on data from animal studies, elafibranor may cause foetal harm when administered to pregnant women. Patients should be informed of the potential risk to the foetus if elafibranor is taken during pregnancy. The use of elafibranor is not recommended during pregnancy and in women of childbearing potential not using effective contraception. 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. Elafibranor contains less than 1 mmol sodium (23 mg) per dose that is to say essentially ‘sodium-free’. Hypersensitivity Reactions: If severe hypersensitivity reactions occurs, permanently discontinue elafibranor. If a mild or moderate hypersensitivity reaction occurs, stop elafibranor and treat promptly before continuing with the follow up until resolution of the signs and symptoms. Fractures: Consider the risk of fractures in the care of patients treated with elafibranor and monitor bone health according to current standards of care. Interaction with fibrates: Fibrates and elafibranor act on some similar pathways. Due to the potential for pharmacodynamic interactions and the exclusion of concomitant fibrate use in clinical studies, data on their combined use is limited. Therefore, concomitant administration is not recommended. Fertility, pregnancy and lactation: No human data on the effect of elafibranor on fertility are available. Animal studies do not indicate any direct or indirect effects on fertility or the ability to reproduce. Elafibranor is not recommended in women of childbearing potential not using effective contraception because of potential harm to the foetus. Women of childbearing potential should continue to use effective contraception during and up to at least for 3 weeks following the final dose of elafibranor. The pregnancy status of patients of childbearing potential should be checked prior to initiation of elafibranor treatment. Women planning to become pregnant are recommended to consult with their physician regarding alternate treatment options. There is limited amount of data from the use of elafibranor in pregnant women. Studies in pregnant animals have shown reproductive toxicity. Elafibranor is not recommended during pregnancy. It is unknown whether elafibranor or its metabolites are excreted in human milk. A risk to the suckling child cannot be excluded. Elafibranor should not be used during breastfeeding and for at least 3 weeks following last dose of elafibranor. Undesirable effects: Very Common (≥1/10): abdominal pain, diarrhoea, nausea, vomiting. Common (≥1/100 to <1/10): headache, constipation, cholelithiasis, myalgia, blood CPK increased. Uncommon (≥1/1 000 to <1/100): rash pruritic, blood creatinine increased. Post-marketing experience: Not known. Prescribers should consult the SmPC in relation to other adverse events. Overdose: In the event of suspected overdose, patients should be carefully observed, and appropriate symptomatic treatment and supportive care should be initiated. Legal category: Package quantity: Bottle containing 30 film-coated tablets. Marketing authorisation numbers: EU/1/24/1877/001, 004 and 006. MA Holder: 70 rue Balard, 75015 Paris France. Further information can be obtained from IPSEN Pharmaceuticals Ltd, Blanchardstown Industrial Park, Blanchardstown, Dublin 15. Tel: 018098256. IQIRVO^® is a registered trademark. Date of PI preparation: May 2026 . Ref. IQV-IE-000002