Who is not suitable for long-term use of Seladelpar?

Although Seladelpar has shown promising efficacy in the treatment of primary biliary cholangitis (PBC), not all patients are suitable for long-term use. First of all, patients who are known to be allergic to Seladelpar or its excipients are absolutely prohibited from using it to avoid the occurrence of rashes, allergic reactions or even serious immune reactions. Secondly, patients with severe liver damage or liver failure are not suitable for long-term use. Although Seladelpar mainly works by regulating hepatic bile metabolism and inflammatory pathways, when liver function is severely impaired, drug metabolism may be delayed or accumulated, causing potential safety risks.

Pregnant and nursing women should also use with caution or avoid use. Existing clinical data are insufficient to evaluate the safety of Seladelpar during pregnancy and lactation. Therefore, patients who are pregnant or planning to become pregnant are generally recommended to take alternative treatments or to postpone medication. In addition, for patients with severely impaired renal function, although clinical data are limited, it is recommended to conduct individualized risk assessment under the guidance of a doctor to avoid adverse reactions caused by abnormal drug metabolism.

Patients with serious cardiovascular disease, immune system abnormalities, or being treated with other experimental drugs also need to carefully evaluate the risks of long-term use. Overseas guidelines emphasize that long-term use of Seladelpar should be done under the supervision of a doctor. Liver function, bilirubin levels and blood indicators should be regularly monitored, and the dose should be adjusted or discontinued based on the results.

In addition, patients with active infections or systemic inflammatory diseases also need to note that althoughSeladelpar has a mild immunosuppressive effect, long-term use may still affect the body's immune defenses. In clinical practice, through strict patient screening, regular laboratory monitoring and individualized adjustment of medication regimens, potential risks can be significantly reduced and medication safety ensured.

In summary, people who are not suitable for long-term use of Seladelpar mainly include people with known allergies, people with severe liver damage, pregnant and lactating women, and patients with complex comorbidities or who are taking specific drugs.

Reference materials:https://go.drugbank.com/drugs/DB12390