Iqirvo (Elafibranor) for PBC

Overview
Iqirvo is approved by the U.S. Food and Drug Administration (FDA) for the treatment of primary biliary cholangitis (PBC) in adults. It is prescribed in combination with ursodeoxycholic acid (UDCA) for individuals who don’t have an adequate response to UDCA or as a monotherapy (stand-alone therapy) for those who are unable to tolerate UDCA. This FDA approval is based on the drug's ability to reduce alkaline phosphatase (ALP) levels, but as of June 2024, it is not yet confirmed that the drug improves survival or prevents liver decompensation (worsening of liver function). Continued approval depends on further confirmation of its benefits in clinical trials. Iqirvo is also known by its drug name, elafibranor.

Iqirvo belongs to the peroxisome proliferator-activated receptors (PPAR) agonist category. It works by activating PPARs, which play a role in regulating inflammation and metabolism in the liver. This action helps manage PBC by reducing liver enzyme levels, particularly ALP.

How do I take it?
Prescribing information states that Iqirvo is taken orally once daily, with or without food. It is important to follow the prescribed dosing schedule exactly as directed by a healthcare provider.

Side effects
According to the prescribing information, common side effects of Iqirvo include weight gain, diarrhea, abdominal (stomach) pain, nausea, vomiting, arthralgia (joint pain), constipation, muscle injury, fractures, gastroesophageal reflux disease (GERD), dry mouth, weight loss, and rash.

Rare but serious side effects may include myalgia (muscle pain), myopathy (muscle disease), rhabdomyolysis (severe muscle breakdown), bone fractures, drug-induced liver injury, hypersensitivity reactions, and biliary obstruction (blockage of bile ducts). Pregnant individuals should be aware that the drug may also harm an unborn fetus.

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Highlights of Prescribing Information: Iqirvo (elafibranor) Tablets, for Oral Use — U.S. Food and Drug Administration