What are the side effects of Elafibranor-Iqirvo?

PivotalRelevant phase III clinical trial data demonstrate that Elafibranor-Iqirvo is an effective second-line treatment for patients with primary cholangitis (PBC), with favorable benefit and risk data. The approval of Iqirvo may address an unmet need and potentially reduce alkaline phosphatase (ALP) levels in patients with primary cholangitis. Like other drugs, it may have some intolerable side effects.

The most common adverse reactions to Iqirvo in ≥10% of study participants included weight gain, abdominal pain, diarrhea, nausea, and vomiting. Although these side effects are common, they usually do not have a serious impact on the patient's daily life, and most can be alleviated by adjusting the dosage of the medication or taking other treatment measures.

In addition to the common side effects mentioned above, some study participants who receivedIqirvo also experienced more serious side effects. For example, some patients develop myalgia, myopathy, and rhabdomyolysis, conditions that can lead to muscle pain, weakness, and even kidney failure. Therefore, during the use of Iqirvo, doctors need to pay close attention to the patient's muscle condition and conduct relevant examinations regularly.

In addition,Iqirvo may cause an increased risk of fractures. This may be related to the drug's effect on bone health, so patients should maintain appropriate calcium and vitamin D intake while using Iqirvo to reduce the risk of fractures. Drug-induced liver injury is also a potential risk with Iqirvo. Although this condition is rare, when it occurs it can cause severe liver damage. Therefore, while using Iqirvo, patients should undergo regular liver function tests so that any abnormalities can be detected and dealt with promptly.

For pregnant and nursing women, Iqirvo may have adverse effects on fetal and neonatal development. Therefore, these people should consult a doctor before using Iqirvo and make a decision after weighing the pros and cons.