Elafibranor
Biliary Liver Cirrhosis
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
No
Pharmaceutical Class
NA
Controlled Drug Substance
No
Elafibranor
Summary
Elafibranor is used to treat primary biliary cholangitis (PBC) in adults, especially those who have not responded well to ursodeoxycholic acid (UDCA) or cannot tolerate it.
Elafibranor works by activating peroxisome proliferator-activated receptors (PPARs). This helps decrease the production of bile acids and increases their movement out of the liver, reducing liver damage.
The usual daily dose for adults is 80 mg taken orally once a day with or without food. The safety and effectiveness of Elafibranor in children have not been established.
Common side effects of Elafibranor include weight gain, diarrhea, abdominal pain, nausea, and vomiting. Serious adverse effects can include muscle pain, liver injury, and bone fractures.
Elafibranor is not recommended for use during pregnancy, breastfeeding, or in patients with decompensated cirrhosis. It may cause muscle pain and increase the risk of bone fractures and liver injury.
Indications and Purpose
How does Elafibranor work?
Elafibranor works by activating peroxisome proliferator-activated receptors (PPARs), specifically PPAR-alpha and PPAR-delta. This activation helps decrease the production of bile acids and increases their movement out of the liver, reducing toxic levels and preventing liver damage.
Is Elafibranor effective?
Elafibranor has been shown to be effective in treating primary biliary cholangitis (PBC) in adults, particularly in those who have not responded well to ursodeoxycholic acid (UDCA) or cannot tolerate it. Clinical studies have demonstrated its ability to reduce alkaline phosphatase (ALP) levels, a marker of liver function, which is a key indicator of its effectiveness.
What is Elafibranor?
Elafibranor is used to treat primary biliary cholangitis (PBC) in adults, especially those who have not responded well to ursodeoxycholic acid (UDCA) or cannot tolerate it. It works by activating peroxisome proliferator-activated receptors (PPARs), which help decrease bile acid production and increase their movement out of the liver, reducing liver damage.
Directions for Use
For how long do I take Elafibranor?
Elafibranor is typically used for at least 52 weeks, as seen in clinical studies. However, the exact duration of use should be determined by a healthcare provider based on individual patient needs and response to treatment.
How do I take Elafibranor?
Elafibranor should be taken orally once a day, with or without food, at the same time each day. There are no specific food restrictions, but it should be taken at least 4 hours before or after bile acid sequestrants to ensure proper absorption.
How long does it take for Elafibranor to start working?
Elafibranor may start to show effects as early as 4 weeks after beginning treatment, with continued improvement over time. However, the exact time frame can vary depending on individual response and should be monitored by a healthcare provider.
How should I store Elafibranor?
Elafibranor should be stored at room temperature, between 15°C to 30°C (59°F to 86°F), in its original package to protect from moisture and light. Keep it out of reach of children and do not store it in the bathroom.
What is the usual dose of Elafibranor?
The usual daily dose for adults is 80 mg taken orally once a day, with or without food. The safety and effectiveness of Elafibranor in children have not been established, so there is no recommended dose for children.
Warnings and Precautions
Can Elafibranor be taken safely while breastfeeding?
Elafibranor should not be used while breastfeeding and for at least 3 weeks after the last dose due to the potential for serious adverse reactions in the breastfed infant. Consult your healthcare provider for alternative treatments or feeding options during this period.
Can Elafibranor be taken safely while pregnant?
Elafibranor is not recommended during pregnancy due to potential harm to the fetus, as evidenced by animal studies showing developmental toxicity. Women of childbearing potential should use effective contraception during treatment and for 3 weeks after the last dose. If pregnancy occurs, contact a healthcare provider immediately.
Can I take Elafibranor with other prescription drugs?
Elafibranor may interact with bile acid sequestrants, which can reduce its absorption and effectiveness. It should be taken at least 4 hours before or after these medications. Additionally, Elafibranor can interact with hormonal contraceptives, potentially reducing their effectiveness, so non-hormonal methods are recommended during treatment.
Is Elafibranor safe for the elderly?
For elderly patients, especially those over 75 years old, closer monitoring of adverse events is recommended due to limited clinical experience. No dosage adjustment is necessary for patients 65 years and older, but caution is advised due to potential increased exposure to the drug.
Is it safe to exercise while taking Elafibranor?
Elafibranor may cause muscle pain or weakness, which could potentially limit the ability to exercise. If you experience these symptoms, it is important to contact your healthcare provider for advice on how to manage them.
Who should avoid taking Elafibranor?
Important warnings for Elafibranor include the risk of muscle pain, myopathy, and rhabdomyolysis, especially in patients with cirrhosis or those taking statins. It may also increase the risk of bone fractures and cause liver injury. Elafibranor is not recommended for use in patients with decompensated cirrhosis or during pregnancy and breastfeeding due to potential harm to the fetus or infant.
