Livdelzi (seladelpar) is a medicine that can treat primary biliary cholangitis (PBC) by reducing the amount of bile in your body. It does this by signaling the body to stop making bile acid.
People with PBC usually have a buildup of bile in their body. You may have no symptoms or you may have fatigue or itching. Over time, you may develop more serious symptoms due to the buildup of bile in your body. Too much bile in the body can lead to inflammation and damage to the liver.
Livdelzi is usually taken together with another medicine for PBC called ursodeoxycholic acid (also called ursodiol or urso).
How Was Livdelzi Studied?
Livdelzi was studied in 193 people with PBC. The people in the study were treated for up to a year with either Livdelzi 10 milligrams daily or a placebo pill. Placebo pills do not contain any active medicine.
In this study, most people were also taking another medicine for PBC – ursodeoxycholic acid – unless they were allergic or had side effects from that medication.
The investigators of this study looked to see if there were any improvements in liver laboratory values, such as the alkaline phosphatase level and bilirubin level, to determine if the medicine worked. They also looked at improvements in itching.
What Types of People Were Included in the Study?
The average age for people in this study was about 57, and most of the people (>90%) were female. Of the people who received Livdelzi, more than 89% were white, about 23% were Hispanic or Latino, about 6% were Asian, and less than 3% were Black or American Indian/Alaska native.
In order to participate in this study, people had to have been taking ursodeoxycholic acid for at least a year or had to have unacceptable side effects with that medicine.
What Are the Main Benefits of Livdelzi Based on the Study?
About 62% of people who received Livdelzi had improvements in their liver tab tests. Only 20% of people who received the placebo pill had improvements in these tests.
People treated with Livdelzi also reported less itching.
Your results may differ from what was seen in clinical studies.
How Long Until I See the Full Effects of Livdelzi?
In the study that evaluated Livdelzi, people started to see improvements in their liver laboratory values right away, usually within the first month.
People started to see improvements in their itching within the first month, and this continued to improve steadily over nine months.
Your results may differ from what was seen in clinical studies.
How Do I Know if Livdelzi Is Working?
If Livdelzi is working, you should start to see your liver lab tests get better over time. You may also see an improvement in itching.
Is It Right for Me?
You should not take Livdelzi if any of the following apply:
- You have advanced liver disease including an advanced form of cirrhosis known as decompensated cirrhosis.
- You have a blockage of the bile ducts in your liver, also known as biliary obstruction.
- You are pregnant.
- You are breastfeeding.
How Do I Manage Side Effects?
Although not common, some people who were treated with Livdelzi in clinical studies had bone fractures. Tell your health care provider if you have had a fracture in the past or are at risk for fractures. Here are some things you can do to improve your bone health:
- Make sure you are getting enough calcium from supplements or calcium-rich foods such as yogurt, tofu, or salmon.
- Make sure you are getting enough vitamin D from supplements or vitamin D-rich foods such as fatty fish, eggs, or fortified eggs or cereal.
- Exercise regularly. This can help build muscle and reduce your risk for falls.
- Quit smoking.
- Reduce your intake of added sugars.
- Limit alcohol.
About 10% of people who were treated with Livdelzi in clinical studies had an increase in a kidney laboratory value called serum creatinine and a reduction in estimated glomerular filtration rate (eGFR). Increases in serum creatinine may be linked to decreased kidney function, although this was not reported in this study. Eventually, the serum creatine returned to normal values. Tell your health care provider if you have any changes in your urine output while taking Livdelzi, and keep all appointments for blood tests while on this medicine.
Common side effects with Livdelzi include headache, abdominal pain, nausea, bloating, and dizziness. Here are some tips for managing these side effects:
- Headaches can be managed with over-the-counter pain-relieving medicines such as aspirin.
- If you have nausea, try to drink clear liquids or ginger ale. Bland foods like crackers or toast may help as well.
- If you are dizzy, avoid sudden movements. Take your time standing up.
- Bloating can be managed with some over-the-counter medicines such as simethicone. Exercise may also help clear gas from your body.
What Types of Drug Interactions Can Happen With Livdelzi?
Several medicines can interact with Livdelzi. This can affect how well it works or increase your risk of side effects.
Livdelzi is ultimately broken down and removed from the body by enzymes, which are called CYP2C9, CYP2C8, CYP3A4, BCRP, P-gp, and OAT3. Other medicines that you may be taking may increase or decrease the amount of these enzymes in your body. Too much or too little of these enzymes may increase or decrease the amount of Livdelzi that is in your body. This may reduce its ability to work or lead to an increased risk for side effects.
Medicines known as bile acid sequestrants may attach to Livdelzi and prevent it from being absorbed into your bloodstream. Medicine that is not absorbed cannot get to the site of action to work. These medicines are sometimes used to lower cholesterol and include colestipol (Colestid), cholestyramine, or colesevelam (Welchol). If you are taking one of these medicines, you should not take it at the same time that you take Livdelzi. Take Livdelzi at least four hours before or four hours after your bile acid sequestrant.
It is important to let your health care provider and pharmacist know about any other medicines that you are taking.
This may not be a complete list of medicines that interact with Livdelzi. Always check with your health care provider.
Is There Any Cost Assistance Available for Livdelzi?
There may be cost assistance to help you afford Livdelzi. You may have options even if you do not have health insurance. Support Path is a service that can help with the following:
- Benefits investigation
- Information on prior authorization or appeals
- Information on patient assistance programs for eligible, uninsured patients
- Information on a copay coupon program
Your health care provider can help you get started, or you can call 855-769-7284 (855-7-MYPATH).
