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PPAR-DELTA AGONIST
Livdelzi (seladelpar) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat adults with primary biliary cholangitis (PBC).
These insights are based on 121 comments about Livdelzi from myPBCteam members. These are the experiences of a small number of people and are not meant to be medical advice.
Benefits:
Considerations:
Livdelzi is a type of peroxisome proliferator-activated receptor (PPAR) delta agonist that changes signals in the liver to lower bile acid production. It may help reduce the production of bile acids. However, the exact way Livdelzi works in people with primary biliary cholangitis is not fully understood.
Doctors prescribe Livdelzi with ursodeoxycholic acid for adults with PBC who have not responded well enough to ursodeoxycholic acid. Livdelzi may also be used alone in adults who cannot tolerate ursodeoxycholic acid.
Livdelzi is taken as a capsule by mouth. It can be taken with or without food.
The recommended dose of Livdelzi is 10 milligrams by mouth once daily.
People who take a bile acid sequestrant should take Livdelzi at least four hours before or four hours after that medicine. If this is not possible, the medicines should be taken as far apart as possible.
This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
These insights are based on 121 comments about Livdelzi from myPBCteam members.
Members who use Livdelzi often say it helps to keep expectations realistic, watch how your body responds, and stay in close touch with your liver specialist. Many members also mention practical issues like lab follow-up, side effects, and cost support as part of starting or staying on treatment.
Get blood work when your doctor orders it.
“I was in the study for Livdelzi and it helped. Urso alone was not able to get all labs back in line. When the study ended at FDA approval, I was not able to get it any longer. My labs reflected the change.”
Talk to your doctor about side effects that bother you.
“At first I had some nausea, but the pharmacist suggested I take the pill after the evening meal and the nausea went away. I am very happy with it.”
Ask your doctor what to expect with Livdelzi.
“Been on Livdelzi for six months combined with ursodiol; no itching, energetic, not fatigued like before.”
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In clinical studies of adults taking Livdelzi the most common side effects occurred in about 5 percent to 8 percent of people. These include:
Livdelzi can cause serious side effects that may require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
Gilead Sciences, Inc, the manufacturer of Livdelzi, offers the Livdelzi Co-pay Savings Program. Eligible people with commercial insurance may pay as little as $0 per prescription.
The Gilead Support Path Program also offers help understanding insurance benefits, navigating prior authorizations and appeals, learning about Medicare Part D and the Medicare Prescription Payment Plan, and accessing the patient assistance program for eligible uninsured people.
To learn more, visit the Gilead Support Path Program website or call 855-769-7284.
Before you start Livdelzi, your doctor will check your health and perform liver blood tests. These may include ALT, AST, total bilirubin, and alkaline phosphatase.
Tell your doctor if you think you may have a blockage in the bile ducts of your liver. Tell your doctor if you have any allergies to seladelpar or any ingredients in Livdelzi.
Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
Be sure to tell your doctor if you take a bile acid binding resin. These medicines may reduce how much Livdelzi your body absorbs. Take Livdelzi at least four hours before or four hours after a bile acid binding resin. If that is not possible, take the medicines as far apart as possible.
Livdelzi is not recommended for people who have or develop decompensated cirrhosis, which is advanced liver disease. Signs may include fluid buildup in the abdomen, bleeding from enlarged veins, or confusion.
If you are pregnant, planning to become pregnant, or breastfeeding while taking Livdelzi, talk with your doctor about the risks and benefits.
It is not known whether Livdelzi can harm your baby if you are pregnant or pass into breast milk. Pregnancies can be reported to the Livdelzi pregnancy safety study at 800-445-3235.
These answers are fact-checked by our editorial staff.
How effective is Livdelzi for PBC?
In a 12-month study of adults with PBC, 62 percent of people taking Livdelzi met the study’s main blood test goal. This was compared with 20 percent of people taking placebo.
Also, 25 percent of people taking Livdelzi reached normal alkaline phosphatase levels, compared with 0 percent taking placebo. By month 12, average alkaline phosphatase levels fell by 134 units per liter with Livdelzi and by 17 units per liter with placebo.
Among people who started the study with moderate to severe itching, itching improved more at month 6 with Livdelzi than with placebo.
These results are based mainly on changes in blood tests. Livdelzi has not been shown to improve survival or prevent liver decompensation.
How long does Livdelzi take to work for PBC?
A greater drop in average alkaline phosphatase was seen as early as one month after starting Livdelzi 10 milligrams once daily. Lower levels were generally maintained through month 12.
Can Livdelzi be used with other medicines for PBC?
Livdelzi is used with ursodeoxycholic acid in adults whose PBC has not responded well enough to that medicine. It may also be used alone in adults who cannot tolerate ursodeoxycholic acid.
Livdelzi is taken once daily, with or without food.
If you take a bile acid sequestrant, take Livdelzi at least four hours before or four hours after it. If this is not possible, take the medicines as far apart as possible.
Some medicines can affect Livdelzi. Avoid taking Livdelzi with probenecid. Your healthcare provider may need to monitor you if you take rifampin, fluconazole, cyclosporine, or certain other medicines.
On myPBCteam, people share their experiences with primary biliary cholangitis, get advice, and find support from others who understand.
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