Seladelpar
Biliary Liver Cirrhosis
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Drug Status
Government Approvals
US(FDA)
WHO Essential Medicine
NO
Known Teratogen
NO
Pharmaceutical Class
NA
Controlled Drug Substance
No
Seladelpar
Summary
Seladelpar is used to treat primary biliary cholangitis (PBC) in adults. This is a liver condition where bile ducts in the liver are slowly destroyed, leading to severe liver damage.
Seladelpar works by activating a receptor in the body called PPAR-delta. This helps to regulate bile acid synthesis in the liver, reducing bile acid production and decreasing liver damage.
The usual daily dose for adults is 10 mg, taken orally once a day. It can be taken with or without food, but for consistency, it should be taken at the same time each day.
Common side effects include headache, abdominal pain, nausea, and dizziness. Some people may experience mental changes like confusion or mood changes. If you experience any severe or persistent side effects, contact your doctor right away.
Seladelpar may cause bone fractures and liver test abnormalities. It's not recommended for patients with severe liver disease or complete bile duct blockage. If you're pregnant, breastfeeding, or taking certain other medications, consult your doctor before starting Seladelpar.
Indications and Purpose
How does Seladelpar work?
Seladelpar is a peroxisome proliferator-activated receptor (PPAR)-delta agonist. It works by activating PPARδ, which is a nuclear receptor that helps regulate bile acid synthesis in the liver. This activation leads to a reduction in bile acid production, which can help decrease liver damage in patients with primary biliary cholangitis (PBC).
Is Seladelpar effective?
Seladelpar is approved for the treatment of primary biliary cholangitis (PBC) in adults who have not responded adequately to ursodeoxycholic acid (UDCA) or cannot tolerate it. Its approval is based on clinical trials showing a reduction in alkaline phosphatase (ALP) levels, a marker of liver function. However, improvement in survival or prevention of liver decompensation events has not been demonstrated.
What is Seladelpar?
Seladelpar is used to treat primary biliary cholangitis (PBC) in adults who have not responded well to ursodeoxycholic acid (UDCA) or cannot tolerate it. It works by decreasing bile production in the liver, helping to reduce liver damage. Seladelpar is a peroxisome proliferator-activated receptor (PPAR)-delta agonist, which helps regulate bile acid synthesis.
Directions for Use
For how long do I take Seladelpar?
Seladelpar is typically used as a long-term treatment for primary biliary cholangitis (PBC) in adults. The duration of use depends on the patient's response to the medication and the doctor's recommendation. Regular monitoring by a healthcare provider is essential to assess the effectiveness and safety of the treatment.
How do I take Seladelpar?
Seladelpar should be taken orally once a day, with or without food. It is important to take it at the same time each day for consistency. If you are taking bile acid sequestrants, take Seladelpar at least 4 hours before or after these medications. Consult your healthcare provider for any specific dietary restrictions.
How long does it take for Seladelpar to start working?
Seladelpar may start to show a reduction in alkaline phosphatase (ALP) levels as early as one month after starting treatment. However, the full therapeutic effect may take longer, and regular monitoring by a healthcare provider is necessary to assess its effectiveness.
How should I store Seladelpar?
Seladelpar should be stored at room temperature, between 68°F to 77°F (20°C to 25°C). It should be kept in its original container, tightly closed, and out of reach of children. Avoid storing it in the bathroom to prevent exposure to moisture. Always follow storage instructions provided by your pharmacist or healthcare provider.
What is the usual dose of Seladelpar?
The usual daily dose of Seladelpar for adults is 10 mg taken orally once a day. The safety and effectiveness of Seladelpar in children have not been established, so there is no recommended dose for pediatric patients.
Warnings and Precautions
Can I take Seladelpar with other prescription drugs?
Significant drug interactions with Seladelpar include OAT3 inhibitors, strong CYP2C9 inhibitors, and bile acid sequestrants. These can affect the absorption and effectiveness of Seladelpar. Patients should avoid taking Seladelpar with these medications or consult their healthcare provider for guidance on timing and dosage adjustments.
Can Seladelpar be taken safely while breastfeeding?
There is no data on the presence of Seladelpar in human or animal milk, or its effects on the breastfed infant. The benefits of breastfeeding should be weighed against the mother's need for Seladelpar and any potential risks to the infant. Consult a healthcare provider for personalized advice.
Can Seladelpar be taken safely while pregnant?
There is insufficient data from human pregnancies to assess the risk of major birth defects or other adverse outcomes with Seladelpar. Animal studies have shown no malformations at certain doses, but fetal growth reduction was observed at higher doses. Pregnant women should consult their healthcare provider and report pregnancies to the manufacturer for monitoring.
Is Seladelpar safe for the elderly?
In clinical studies, no overall differences in safety or effectiveness were observed between elderly patients (65 years and older) and younger adults. However, due to limited clinical experience with patients older than 75 years, closer monitoring for adverse events is recommended for this age group. Always consult a healthcare provider for personalized advice.
Who should avoid taking Seladelpar?
Important warnings for Seladelpar include the risk of bone fractures and liver test abnormalities. Patients should be monitored for signs of liver problems, such as jaundice or abdominal pain. Seladelpar is not recommended for patients with decompensated cirrhosis or complete biliary obstruction. Always consult a healthcare provider for personalized advice.
