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The safety information provided here highlights potential risks and important precautions associated with the use of Iqirvo (elafibranor). It is crucial to review these details and consult your healthcare provider if you have any questions or concerns.

• Muscle Pain and Damage: Some individuals have experienced muscle pain, weakness, or in rare cases, rhabdomyolysis—a severe muscle condition leading to kidney damage. The likelihood of experiencing these issues may increase if you are taking other medications known to cause muscle problems, such as statins.

• Liver Health: The use of Iqirvo (elafibranor) may result in liver injury, indicated by elevated liver enzyme levels. It is not advised for individuals with moderate to severe liver issues or advanced cirrhosis. Those with a history of liver problems or who consume large amounts of alcohol should exercise caution.

• Bone Fractures: Clinical studies have shown a 6% incidence of fractures among those taking this medication, with some occurring months after initiation. If you have a history of fractures or osteoporosis, inform your healthcare provider. They may recommend monitoring your bone health through tests such as calcium levels or bone density screenings (DEXA scans).

• Pregnancy Risks: If you are pregnant or planning to become pregnant, it is important to discuss this with your healthcare team. Iqirvo (elafibranor) should be avoided during pregnancy and for at least three weeks following the last dose to prevent potential harm to the baby.

• Biliary Obstruction Precaution: Individuals with a complete bile duct blockage should not take Iqirvo (elafibranor). Seek immediate medical attention if you experience symptoms such as upper right abdominal pain or yellowing of the skin and eyes, which could indicate a blockage. Your healthcare provider may advise discontinuing the medication to address the issue.

Please ensure you fully understand these warnings and discuss any questions with your healthcare provider for safe use of Iqirvo (elafibranor).

When taking this medication, some common side effects may occur, which are generally mild and manageable. These include diarrhea, nausea, vomiting, constipation, heartburn, dry mouth, joint pain, and changes in weight. While these effects are often temporary, it is important to consult your healthcare provider if they persist or worsen.

There are also other side effects reported by some individuals, such as dizziness, stomach flu, gallstones, higher creatinine levels, and low red blood cell count (anemia). If you experience any of these, particularly if they are severe, it is advisable to contact your healthcare provider.

On rare occasions, more serious side effects may occur, which require immediate medical attention. These include severe muscle damage, known as rhabdomyolysis, with symptoms such as dark brown urine, severe muscle weakness or pain, fever, and tiredness. Liver problems may also arise, indicated by symptoms like swelling of the stomach, yellowing of the skin or eyes, changes in stool, and confusion. Additionally, bone fractures and serious allergic reactions, characterized by rash, itching, trouble breathing, and swelling of the face, lips, tongue, or throat, are possible but rare.

If you notice any other effects not listed here, it is important to reach out to your healthcare provider for guidance. Always monitor your health and seek medical assistance whenever necessary to ensure your safety and well-being.